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SURGERY | ORIGINAL RESEARCH
COMPARATIVE STUDY BETWEEN LAPAROSCOPIC
AND OPEN CHOLECYSTECTOMY (STUDY OF 50
CASES)
Ketan Vagholkar∗,1, Siddharth Nachane∗ and Suvarna Vagholkar∗
∗Department of Surgery, D.Y.Patil University school of Medicine, Navi Mumbai-400706. MS. India
ABSTRACT Background: Laparoscopic cholecystectomy is a new alternative to the traditional open approach for
treating calculous cholecystitis. It is, therefore, necessary to assess the efficacy of laparoscopic cholecystectomy over the
open cholecystectomy. Objectives: To compare the surgical outcomes of laparoscopic cholecystectomy with those of open
cholecystectomy. Materials and methods: 50 patients diagnosed as symptomatic cholelithiasis proven by radiological
investigations were distributed into two groups of 25 each. Group A patients were subjected to laparoscopic cholecys-
tectomy, and group B patients underwent open cholecystectomy. The surgical outcomes were studied prospectively.
Intraoperative complications and postoperative care parameters were evaluated. Results: Mean age of patients in group
A was 46.68±13.6 years, and in the group, B was 42.64±14.1 years. Majority of patients were in the age group of 41 to 60
years. Patients who had diabetes in group B developed wound infections, whereas diabetic patients in group A did not
develop any infection. Significant bleeding necessitating blood transfusion occurred in one patient belonging to group B.
The duration of postoperative analgesia required was 3.16 days in group A and 5.16 days in group B. The duration of
postoperative antibiotics administered in laparoscopic and open cases was 1.48 and 4.8 days, respectively. One of the
patients in group A developed a postoperative biliary leak, whereas none in group B had any such complication. The
commencement of oral feeds and after that return of bowel movements was earlier in group A than group B. The mean
hospital stay was 4.5 days in group A as compared to 6.3 days in group B. Conclusion: Laparoscopic cholecystectomy
is superior to open cholecystectomy regarding reduced postoperative discomfort and pain, antibiotic and analgesic
requirement, early commencement of oral feeds, and shorter duration of hospitalization.
KEYWORDS Laparoscopic, Open, Cholecystectomy, Complications, Comparison
Introduction
Gallstone disease is one of the most common digestive disease
encountered by the general surgeon. This was traditionally dealt
Copyright © 2021 by the Bulgarian Association of Young Surgeons
DOI:10.5455/IJMRCR.Comparative-study-between-laparoscopic-and-open-
cholecystectomy
First Received: December 27, 2020
Accepted: January 14, 2021
Associate Editor: Ivan Inkov (BG);
1
Department of Surgery, D.Y.Patil University school of Medicine, Navi Mumbai-400706.
MS. India, Email: kvagholkar@yahoo.com
with by open cholecystectomy. Although open cholecystectomy
has been performed with minimal morbidity and mortality, the
search for better alternatives continued. The advent of minimal
access surgery revolutionised the treatment of gallstone dis-
ease. Laparoscopic cholecystectomy was quickly picked up all
over the world for treating gallstone disease. Patients preferred
laparoscopic technique as it involved significantly less morbid-
ity and shorter hospital. Growing experience in laparoscopic
cholecystectomy has made the procedure safe. However, some
surgeons still suggest that serious complications, particularly
bile duct injuries, are significantly higher during laparoscopic
cholecystectomy resulting in higher morbidity and occasionally
mortality. Open cholecystectomy is still performed in various
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
countries from the developing world. However, one cannot
deny that a surgeon has to be well-versed with the technique of
open surgery as open surgery continues to be the salvage for pre-
venting serious complications during complicated laparoscopic
cholecystectomy. The present study attempts to compare and
contrast laparoscopic cholecystectomy with open cholecystec-
tomy.
Aims and objectives:
The study aims at comparing laparoscopic cholecystectomy and
open cholecystectomy concerning:
1. Blood loss during surgery.
2. Complications, including bile duct injuries.
3. Antibiotic and analgesic requirements.
4. Postoperative pain.
5. Duration of hospital stay.
Materials and methods:
The study protocol was approved by the institutional ethics com-
mittee before commencing the study. Fifty patients diagnosed
as symptomatic cholelithiasis proven by radiological investiga-
tions presenting to a single surgical unit in an urban teaching
hospital from January 2017 to December 2017, were distributed
into two groups of 25 each. Twenty-five patients in group A un-
derwent laparoscopic cholecystectomy, and 25 patients in group
B underwent open cholecystectomy.
Inclusion criteria:
All patients with symptomatic gallstone disease proven by radi-
ological investigations.
Exclusion criteria:
1. History of investigations suggestive of choledocholithiasis.
2. History of previous abdominal surgery.
3. Conversion of laparoscopic to open cholecystectomy be-
cause of difficult anatomy and technical difficulties.
On admission to hospital, a detailed clinical history was ob-
tained from all the patients. The physical examination followed
by blood tests were done. Patients were explained in detail
both the options of cholecystectomy while obtaining written
informed consent.
Patients were equally distributed into two groups based on
odd or even last digit of their indoor medical record number.
Group A, in which patients underwent laparoscopic cholecys-
tectomy, and group B patients underwent open cholecystectomy.
All patients were kept nil strictly orally overnight before surgery.
Perioperative antibiotics were administered, comprising of injec-
tion ceftriaxone 1 gm in three doses. Antibiotics were continued
in patients who developed surgical site infections. A nasogastric
tube was placed in all patients after induction of general anaes-
thesia to prevent the dilated stomach from obscuring the field of
vision. The nasogastric tube was removed on the evening of the
day of surgery. All the operations in both group A and group
B were performed by the first author. Patients were discharged
from the hospital after they passed normal stools. Pain in the
postoperative period was rated by each patient by using a visual
analogue scale from 0 to 10. The data evaluated included patient
demographics, laboratory results, operative findings, postopera-
tive complications, the severity of postoperative pain, duration
of antibiotic and analgesic administration, and length of hospital
stay.
Laparoscopic cholecystectomy
Position
The patient was placed in the supine position with a 15º head
high to improve the respiratory function. Primary 10mm port
was introduced through the sub-umbilical region by the open
method. Another 10 mm port was placed in the epigastrium.
Two 5mm ports were placed laterally, one in anterior axillary
line and another in the midclavicular line. The anterior axillary
line port was used to pass a grasper which holds and pushes the
gallbladder and liver superiorly.
In contrast, the midclavicular port was used to give counter
traction by holding the Hartmann’s pouch laterally with a
grasper during dissection. The gallbladder was dissected as
per standard technique. This included adhesiolysis between
the gallbladder and the omentum. Cystic duct and artery were
identified and skeletonized before clipping. The gallbladder was
dissected free from the cystic plate. Adequate haemostasis was
achieved. The specimen was retrieved by placing it in the plastic
bag through the sub umbilical port. The 10 mm port sites were
closed with 1-0-prolene whereas the skin was approximated
with 3-0 monocryl. Drains were kept in the subhepatic space
only when satisfactory haemostasis could not be achieved and
in cases wherein extensive dissection was carried out. Patients
were allowed a liquid diet on the evening of surgery.
Open cholecystectomy
Position
Patient was placed in the supine position with a slight elevation
of the head end.
Incision:
The Kocher’s right subcostal incision was made in all patients
belonging to the open group. The gallbladder was appropriately
exposed after packs being placed on the hepatic fixture, duode-
num, and liver. Gallbladder found to be distended emptied by
aspirating the bile using the syringe. Fundus first method was
adopted in 25 patients. A subhepatic tube drain was kept in all
patients. Skills staples were removed on 10th postoperative day.
Results
Fifty patients undergoing cholecystectomy were studied after
being divided into two groups, namely group A, in which 25
patients underwent laparoscopic cholecystectomy and group B,
in which 25 patients underwent open cholecystectomy.
1. Age The mean age of patients in group A was 46.68±13.6
years, and group B was 42.64±14.1 years. Majority of pa-
tients were in the age group 41 to 50 across both groups A
and B. (Table 1) these observations did not impact surgical
outcomes.
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
2. Sex Five patients of group A and three patients of group B
were males. Among group A, 20 patients and group B, 22
patients were females.
3. Symptomatology The common presenting symptom in both
groups A and B was a pain in the right hypochondrium.
Three patients in group A and six patients in group B had
only right upper quadrant pain. Six patients in group A
and six patients in group B had vomited in addition to pain.
Sixteen patients in group A and 13 patients in group B had
flatulent dyspepsia. None of the patients had jaundice or
previous history of jaundice. The multitude of symptoms
did not reach statistical significance. (Table 2)
4. Ultrasonography findings All patients in either of the
groups underwent abdominal ultrasonography. Solidary
calculus was found in 4 patients from group A, and six pa-
tients from group B. Multiple stones were seen in 20 and
18 patients of group A and B, respectively. Biliary sludge
was found in 2 patients from group A and one patient from
group B. (Table 3) The data was found to be statistically
significant.
5. Co-morbid Conditions Six patients in group A and seven
patients in group B had diabetes. (Table 4) Though the
observation was not found to be statistically significant.
Five patients in group A and eight patients from group
B were hypertensive. (Table 4) This was statistically not
significant.
6. Intraoperative complications Significant intraoperative
blood loss was defined as ≥ 100 cc, which occurred in
only one patient belonging to group B. The patient was
hypertensive.
The most important intraoperative complication noted was
bile spillage due to accidental rupture of the gall bladder
seen in one patient in group A. Stone spillage was seen
in the same patient in group A and no patient in group B.
There was no CBD injury in either group detected on the
table. Sub hepatic drains were required for ten patients in
group A and 25 patients in group B. Sub hepatic drains were
kept in all patients belonging to group B. This observation
was statistically significant. (Table 5)
7. Duration of drain placement Sub hepatic drains were kept
in all patients in group B and ten patients in group A. The
duration of drains kept was 0.96±1.2 days in group A, and
3.16±1.2 days in group B. (Table 5) The duration was signif-
icantly lower in group A patients.
8. Pain score and medication The pain score on a visual ana-
logue scale (VAS) was less in group A patients as compared
with VAS score in group B for all the three days. (Table 6)
The duration of postoperative analgesia in group A was
3.16±2.41 days compared to 5.16±1.8 days in group B.
(p=0.002). The difference in values was statistically sig-
nificant
9. Postoperative outcomes No surgical site infection was seen
in group A patients, whereas 3 patients belonging to group
B developed surgical site infection.(p=0.297) One patient
from group A developed a biliary leak which was detected
within 48 hours and managed by ERCP with stenting. None
of the group B patients developed any biliary leak. Peri-
operative antibiotics were given (1.48±1.8 days) to group
A patients compared to 4.8±0.7 days in group B patients.
(Table 7)
10. Postoperative recovery Group A commenced oral feeds in
2.36±1.2 days while group B patients commenced oral feeds
in 3.16±0.7 days (significant, p = 0.010). Bowel movements
regained normalcy in 3.52±1.8 days in group A compared
to 4.76±1.1 days in group B (significant, p = 0.005). The
duration of hospital stays was4.48±2.9 days in group A and
6.32±2.1 days in group B. The difference in the duration of
stay between the two groups was statistically significant (p
= 0.015). (Table 8)
Table 1 Age distribution and range
Group N Mean Std. Devia-
tion
A 25 46.68 13.698
B 25 42.64 14.124
Age (Years) Group A Group B
<=30 4 6
31-40 4 6
41-50 10 10
51-60 2 2
61-70 5 1
Total 25 25
(Unpaired
t-test)
P value = 0.310 (Not Significant)
Table 2 Clinical Presentation
Clinical
Presentation
Group A Group B
Only Pain in
RUQ
3 6
Vomiting 6 6
Dyspepsia 16 13
Pain with
other Symp-
toms
25 25
P value >0.05
(chi square
test)
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
Table 3 Ultrasonography findings
USG Findings Group A Group B
Solitary
Calculus
7 6
Multiple Cal-
culi
16 18
Sludge 2 1
Total 25 25
P value >0.05
(chi square
test)
Discussion
Open cholecystectomy has always withstood the test of time as
a standard of care for gallstone disease. With the advent of mini-
mal access surgery, open cholecystectomy for gallstone disease
has become a less preferred technique. Laparoscopic cholecystec-
tomy has now become the gold standard of care. However, one
has to accept that laparoscopic surgery also has its limitations,
wherein open surgery remains the only salvage. The experi-
ence with open surgery in the younger generation of surgeons
is dwindling rapidly almost to the verge of extinction. Many
times, difficult dissections make laparoscopic cholecystectomy a
dangerous procedure. In such circumstances, it is always safe to
convert to an open procedure. [1] Hence the present study was
carried out in order to refresh the pros and cons of open surgery
as compared with laparoscopic surgery.
With the advent of minimal access surgery, younger age
group patients prefer laparoscopic cholecystectomy over the
open procedure. [1] In the present study, most patients in both
groups were in the age group of 41 to 50 years. The efficacy of
laparoscopic cholecystectomy in various age groups was com-
pared with the open procedure. However, the results were not
statistically significant. Older age group patients also prefer to
undergo laparoscopic cholecystectomy. [2] Studies have shown
that they have better outcomes as well as reduced morbidity due
to quick recovery. [1, 2]
Majority of patients in the present study were females. La-
paroscopic cholecystectomy in male patients is associated with
a high conversion rate. Therefore, it is considered a risk factor
for conversion. [3, 4, 5]
Patients selected in each group presented with symptoms of
pain in the right hypochondrium, vomiting, and dyspepsia. All
these patients had a chronic indolent course. The symptomatol-
ogy of the disease presented did not influence the surgical out-
comes irrespective of the type of procedure performed (p>0.05).
The diagnosis of gallstones was confirmed in all the patients by
abdominal ultrasonography. Sixteen patients in group A and 18
patients in group B had multiple calculi. Seven patients in group
A and six patients in group B had a solitary calculus. Two pa-
tients in group A and one patient in group B had biliary sludge.
The severity of stone disease by stone load did not influence the
nature and outcome of the surgical technique. [6]
Diabetes, hypertension, and ischemic heart disease are the
common comorbid medical conditions associated with advanced
age. [7, 8] Diabetes is usually associated with high cholesterol
Table 4 Co-morbid conditions (Diabetes Mellitus & Hyperten-
sion)
Diabetes Mel-
litus
Group A Group B Total
No 19 (76%) 18 (72%) 37 (74%)
Yes 06 (24%) 07 (28%) 13 (26%)
Total 25 (100%) 25 (100%) 50 (100%)
X2 = 0.014 DF=1 P value
=0.747
(Not Sig-
nificant)
(chi square
test)
Hypertension Group A Group B Total
No 17 (68%) 20 (80%) 37 (74%)
Yes 08 (32%) 05 (20%) 13 (26%)
Total 25 (100%) 25 (100%) 50 (100%)
X2 = 0.936 DF=1 P value
=0.333
(Not Sig-
nificant)
(chi square
test)
which predisposes to the development of gallstones. The pecu-
liarity of diabetic patients is that the severity of gallstone disease
is invariably missed due to masking of symptoms. [9, 10, 11]
Diabetic patients are more prone to septic complications, in-
cluding surgical site infections, thereby contributing to the mor-
bidity in these patients. A minimally invasive approach, there-
fore, is of great advantage as it reduces the chances of septic
complications.[9, 10, 11] Open approach involves a bigger inci-
sion and puts increased demand on the wound healing process,
which in diabetic patients is seriously compromised. As a result,
diabetic patients develop a multitude of complications ranging
from intra-abdominal sepsis to surgical site infections. Therefore,
laparoscopic cholecystectomy has a major advantage over the
open method in diabetic patients. In the present study, seven
patients in group B and six patients in group A had diabetes.
Three patients who developed surgical site infections had dia-
betes and belonged to group B. None of the patients in group A
developed surgical site infections. However, as the sample size
was small, statistical significance could not be determined.
Hypertension is another comorbidity which poses a chal-
lenge. [12, 13] Adequate preoperative control of hypertension is
mandatory. Despite good control yet intraoperative complica-
tions can occur during laparoscopic cholecystectomy requiring
conversion to open. In the present study, three diabetic patients
in group B developed infection out of which 2 had a history of
hypertension. 8 out of 25 patients in group B were hypertensive.
One of these patients developed significant intraoperative bleed-
ing (>100cc) requiring a blood transfusion. In group A patients,
five patients had hypertension, but none of them developed any
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
Table 5 Intra-Operative Complications
Intra-operative Findings Group A Group B
Significant Blood Loss(>100cc) 0 1
Blood replaced 0 1
Bile/stone Spillage 1 0
Drains used 10 25
Intraoperative Complications (Blood transfusion) Group A Group B Total
No 25 (100%) 24 (20%) 49 (98%)
Yes 00 (0%) 01 (04%) 01 (02%)
Total 25 (100%) 25 (100%) 50 (100%)
X2 = 1.020 DF=1 P value =0.312 (Not Significant) (chi square test)
Intraoperative Complications (Drain) Group A Group B Total
No 15 (60%) 00 (00%) 15 (30%)
Yes 10 (40%) 25 (100%) 35 (70%)
Total 25 (100%) 25 (100%) 50 (100%)
X2 = 21.429 DF=1 P<0.001(Significant) (chi square test)
Group N Mean SD ‘p’ value Significance
Duration of the drain (days) A 10 0.96 1.274 <0.001 Significant
B 25 3.16 1.463
(Unpaired T-test)
bleeding. As the process of laparoscopic technology evolves,
better methods of achieving haemostasis are available. This has
reduced the chances of bleeding. As a result, the conversion rate
due to bleeding has decreased significantly. Harmonic scalpel
and argon B laser technologies have empowered surgeons to
achieve excellent haemostasis at the time of surgery.
Ischemic heart disease is a common accompaniment of gall-
stone disease, especially in the older age group of patients.[12,
13] Multiple reports have suggested the high incidence of car-
diopulmonary complications in patients undergoing biliary type
surgery.[14,15,16] Various intraoperative issues can alter the nor-
mal surgery course, both during laparoscopic and open surgery.
Intraoperative bleeding is one such complication. A magni-
fied appearance in laparoscopic cholecystectomy enables better
haemostasis to be achieved. Judicious use of bipolar cautery will
suffice in the majority of situations. Due to accidental perforation
spillage of bile occurred in one patient undergoing laparoscopic
cholecystectomy. Bile spillage due to accidental perforation
during laparoscopic cholecystectomy usually occurs while dis-
secting the gallbladder from the inferior surface of the liver. [17]
It is essential to maintain adequate traction on the gallbladder
while dissecting the plane between the gallbladder and the liver.
[18] The surgeon needs to suck all the spilt bile followed by
saline irrigation before proceeding.
Stone spillage is another consequence of accidental gall blad-
der perforation during dissection. [17, 18] In the present study,
one patient undergoing laparoscopic cholecystectomy had stone
spillage during surgery due to accidental perforation of the gall
bladder. Whenever stones are spilt, they need to be meticulously
picked up and removed. To prevent spillage, it would be a safe
practice to take an intracorporeal stitch to close the site of per-
foration. [18] This would prevent further leakage of bile and
spillage of stones. Dropped stones in the peritoneal cavity can
elicit an inflammatory reaction leading to an abscess. In the
present study, such complications did not occur.
Whenever there is extensive tissue dissection, there is oozing
of blood and tissue fluid. If this fluid accumulates, it can lead to
the formation of an abscess. Therefore it is a safe practice to place
a closed tube drain at the operative site to drain such collections.
Another advantage of placing drains is the early diagnosis of
bile leak which could either be from the inferior surface of the
liver due to damage to superficial small biliary ductules, or
even the hepatic or common bile duct in complicated cases.
The advantage of picking up on bile leak early undoubtedly
outweighs the suspense created by a wait and watch policy in
patients wherein drains were not kept. [19, 20]
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
Table 6 Pain Score and Medication:
Group A (n=25) Group B (n=25) ‘p’ value Significance
VAS 1 5.28±0.792 7.52±1.005 <0.001 Significant
VAS 2 3.92±0.909 6.08±0.909 <0.001 Significant
VAS 3 2.84±1.143 4.84±0.850 <0.001 Significant
Postoperative analgesia required (days) 3.16±2.410 5.16±1.818 0.002 Significant
(Unpaired t-test)
Table 7 Postoperative outcomes
Postoperative Complications Group A Group B
Wound Infection 0 3
Biliary Leak 1 0
Perioperative Antibiotics (days) 1.48 4.8
Postoperative Complications (wound infection) Group A (n=25) Group B (n=25) Total
Nil 25 (100%) 22 (88%) 47 (94%)
Yes 00 (00%) 03 (12%) 03 (06%)
Total 25 (100%) 25 (100%) 50 (100%)
X2 = 1.087 DF=1 P value =0.297 (Not Significant) (chi square test)
Postoperative Complications (Biliary leak) Group A (n=25) Group B (n=25) Total
Nil 24 (96%) 25 (100%) 49 (98%)
Yes 01 (04%) 00 (00%) 01 (02%)
Total 25 (100%) 25 (100%) 50 (100%)
Group A (n=25) Group B (n=25) ‘p’ value Significance
Perioperative antibiotics (days) 1.48±1.828 4.80±0.707 <0.001 Significant
Unpaired t test
In the present study, a 14F Ryle’s tube was placed in 10 pa-
tients undergoing laparoscopic cholecystectomy. Because they
had a difficult dissection with the likelihood of leakage whereas,
in the open group, intra-abdominal drains were kept in all 25
patients. In the group of patients who underwent laparoscopic
cholecystectomy, a postoperative bile leak was detected in one
patient who immediately underwent ERCP and stenting. The
use of drains has always been a contentious issue. Opponents of
this concept attribute it to a higher incidence of ascending infec-
tion. [20] However, the present study suggests that it is a safe
practice devoid of complications to place a drain in the hepatore-
nal pouch, especially in cases which are technically demanding.
[21, 22, 23, 24, 25]
Pain is a very subjective and complex mechanism with physi-
cal, emotional, and cognitive components. [26] It is a subjective
concept which is difficult to quantify. Every individual has a dif-
ferent threshold for pain. Hence the need for anaesthesia differs
from person to person. Pain has a multitude of effects on the
human body. Pulmonary complications may develop rapidly in
patients suffering from severe pain. In the present study, the vi-
sual analogue scale (VAS) score was used to assess postoperative
pain. Visual Analogue Scale (VAS) is a psychometric response
scale. VAS provides an objective method for assessment with
better compliance and easy reproducibility. [27, 28, 29] In the
present study, the pain was assessed on three consecutive days
with the help of VAS. It was observed that on day 1, the pain
was significantly less in patients undergoing laparoscopic chole-
cystectomy compared to open cases. The same observation was
noted on day 2 and day 3. The advantage of this observation
was that the need for analgesia was significantly less in patients
undergoing laparoscopic cholecystectomy—analgesic or pain
control protocol used in the present study comprised of parac-
etamol infusion. In the group who underwent open surgery,
analgesics were administered for 48 hours, followed by oral
drugs. Analysis of these observations yielded statistically sig-
nificant results, thereby proving the superiority of laparoscopic
cholecystectomy over open surgery.
Cholecystectomy, whether open or laparoscopic, is classified
as a clean-contaminated procedure. However, in bile and stone
spillage, it can best be reclassified as a contaminated procedure.
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
Table 8 Postoperative recovery
Group A (n=25) Group B (n=25) ‘p’ value Significance
Oral feed day 2.36±1.827 3.16±0.746 0.01 Significant
Bowel habits returned day (passage of stool) 3.52±1.873 4.76±1.012 0.015 Significant
Hospital stay 4.48±2.974 6.32±2.135 0.015 Significant
(Unpaired t-test)
Bile in gallbladder containing stones is always potentially in-
fected. Hence spillage of this bile can increase the chances of
infection. It is a good practice to administer antibiotics for all
clean-contaminated procedures. [30] In the present study, peri-
operative antibiotics were administered to patients belonging to
both groups. A combination of ceftriaxone and amikacin was
used. Check dressing of the surgical wounds was done after
48 hours. None of the patients belonging to the laparoscopic
cholecystectomy group had an infection. However, three pa-
tients in the open group developed surgical site infections. A
swab from the site was taken from infected cases and was found
to grow staphylococcus aureus. These patients were continued
on a course of antibiotics for five days. One of the patients
had partial wound dehiscence requiring secondary suturing,
whereas the other two healed by regular dressings. Therefore
the observation that there is a lesser requirement of antibiotics
in laparoscopic cases was substantiated in the study.
Wound infection as a complication following any surgery
is related to a multitude of factors which can be classified as
patient-related factors, surgical factors, and pathological factors.
Patient-related factors include the patient’s nutritional status
and comorbid medical conditions. In the present study, all three
patients who developed wound infection had diabetes. Surgical
factors include meticulous skin preparation protocols, diligent
surgical techniques, achieving good haemostasis, and judicious
use of drains. Despite taking all precautionary care, yet infec-
tions do develop, which can be attributed to difficult dissection
and prolonged duration of surgery. [29, 30] In the present study,
comorbid factors played a role in developing a wound infection.
Patients suffering from empyema of the gallbladder have an in-
creased chance of developing sepsis. Patients with an obstructed
biliary system can also develop complications. Laparoscopic
cholecystectomy under smaller incisions significantly reduces
the potential of wound infection. However complex infections
do develop at the sub umbilical port site in laparoscopic chole-
cystectomy. These are resistant to treatment as they are caused
by organisms such as atypical mycobacteria. Cleaning the um-
bilicus before the surgery is, therefore of utmost importance in
preventing port site infections.
Damage to the extrahepatic biliary passages, especially the
common bile duct is a catastrophic laparoscopic cholecystec-
tomy complication. Such complications are usually created by
surgeons who are in the early stages of the learning.[31] It is
therefore prudent on the part of the surgeon to ensure that he
is fully aware and competent enough to identify and manage
iatrogenic biliary tract injuries. An adequate number of open
procedures should have been performed before attempting la-
paroscopic procedures. This gives a broad overview of the ma-
jority of anatomical variations in the blood supply and ductal
anomalies of the extrahepatic biliary passages. Iatrogenic in-
juries usually present in three ways depending upon when they
are diagnosed. [31, 32]
Some of these injuries are identified during the surgery itself.
This requires immediate conversion to an open procedure in
order to assess the exact extent of the injury. If the injury hap-
pens to be a rent in the CBD, a T-tube should be placed in the
CBD and further management can be carried out accordingly.
However, if the injury involves a significant length of the CBD or
is accompanied by a vascular injury, the best option is a biliary
enteric procedure.
If the injury is suspected or diagnosed in the early postop-
erative period by way of a bile leak in the drain or as jaundice,
then ERCP is mandatory. If ERCP shows that the continuity of
the CBD is maintained, then stenting is therapeutic.[33] How-
ever, if the CBD appears to be transected entirely manifesting
as jaundice in the early postoperative period, then a judicious
and logical diagnostic algorithm needs to be followed. Percu-
taneous transhepatic drainage needs to be performed to drain
the bile. This should be kept for a period of 8 to 12 weeks. This
will allow inflammation in the porta hepatis to have completely
settled and the process of fibrosis having been completed or
the intensity reduced. [34] The septic implications need to be
attended by a combination of a subhepatic drain introduced by
interventional radiology or by open method accompanied by
an adequate course of antibiotics. Twelve weeks would be a
safe period to be allowed before surgical intervention can be
contemplated. Either a PTC or an MRCP should be performed
to assess the final status of the CBD. This should be followed
by an elective biliary enteric anastomosis preferably hepaticoje-
junostomy.
The third category of patients with biliary tract injury usually
presents with a biliary stricture—the average time frame for this
complication to develop ranges from 6 months to 1 year. The
development may be hastened if there is concomitant vascu-
lar injury. [35] Presence of a vascular injury has a significant
negative outcome on definitive surgery. As per Strasburg clas-
sification, a working algorithm is formulated to manage such
injuries depending on its severity. What is important in such
cases is to rule out the chance of it being a malignant stricture.
Therefore good imaging in the form of ERCP or MRCP is manda-
tory to study the proximal extent of the stricture. The status
of the liver also needs to be assessed as these patients can de-
velop complications of chronic cholestasis with infection and
rarely secondary biliary cirrhosis compromising liver function
at the time of the definitive procedure. [36]Various surgical
options are available dictated by the level of the stricture. Hep-
atico jejunostomy performed on a normal hepatic duct will have
the best surgical outcome because of its superior vascularity
as compared to the CBD. In the rare event of a stricture at the
confluence, the confluence may have to be sacrificed, exposing
the right and left hepatic ducts. A double hepaticojejunostomy
should be performed comprising of a right hepaticojejunostomy
and left hepaticojejunostomy with the same loop of jejunum
placed over a short distance, resulting in a tension-free anasto-
mosis. The incidence of biliary tract injuries during laparoscopic
cholecystectomy has significantly reduced over time due to im-
Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
provisation in both surgical technology and technique. However,
the incidence of such injuries continues to be higher in laparo-
scopic surgery as compared to open surgery. A surgeon should
follow the safety dictum “prevention is better than cure”. In the
context of biliary tract injuries, this envisages conversion to open
surgery anticipating the difficulty in dissection, performing such
procedures under the supervision of an experienced surgeon
initially before starting at an individual level and finally close
monitoring of patients post-operatively. In the present study,
all surgeries were performed by the principal author, who has
been well experienced in biliary surgeries, including salvage
procedures for biliary tract injuries. No major complications
arose in either group, except for one patient in the laparoscopic
group who developed a bile leak in the postoperative period.
An ERCP was performed, which revealed a small leak from the
CBD, which was immediately stented. The leak stopped in 48
hours with no septic complications. The stent was removed after
three weeks. Various studies have observed an increased risk
of bile duct injuries after laparoscopic cholecystectomy (1.1%)
compared to open surgery (0.51%).[31, 33, 35]
Patients always prefer to undergo a procedure which ensures
speedy recovery. As surgery has evolved over the years, so
also has the rapidity of postoperative recovery. Laparoscopy
enables quick recovery as compared to open procedures. La-
paroscopy involves less mechanical handling of tissues, more
accurate dissection, less exposure of abdominal contents, mini-
mal homeostatic imbalances and a better metabolic response to
the surgery. [35, 36] As a result recovery of the gastrointestinal
function is quick, enabling early commencement of oral feeds.
In the present study patients who underwent laparoscopic chole-
cystectomy commenced oral feeding by second postoperative
day compared to those who underwent open surgery which
started oral feeds by the fourth postoperative day. This con-
formed with other studies. Early commencement of oral feeding
is an important, satisfying factor for the patient who has under-
gone surgery. It reduces the hospital stay as compared to open
procedures which were observed in the present study and were
statistically significant. Therefore, there is higher patient com-
pliance and acceptance of the procedure. In the present study,
the mean hospital stay was 4.5 days for laparoscopic cholecys-
tectomy and 6.3 days for open procedures. The results were
statistically significant (p<0.05). However, it needs to be ex-
plained to the patient that in the rare event of a complication, the
hospital stay may be prolonged and may necessitate conversion
to open surgery and ancillary procedures. [36]
The strength of the study is that both procedures were eval-
uated. The limitation of the study was the smaller sample size.
Larger studies will strongly support the superiority of laparo-
scopic cholecystectomy over open cholecystectomy.
Conclusion
Laparoscopic cholecystectomy is the gold standard for treating
gallstone disease for several proven reasons.
1. Shorter duration of hospital stays increases patient accept-
ability allowing patients to resume routine activities earlier.
2. Concerning the surgical aspects, it decreases the morbid-
ity associated with the surgery significantly as the dissec-
tion’s quality is better, chances of wound infection are less,
thereby precluding prolonged antibiotic usage. Concerning
the recovery phase, there is a significant decrease in postop-
erative pain. As a result, there is a decrease in the duration
of analgesia required. Oral feeds are commenced early, thus
achieving early recovery to normalcy.
Acknowledgement:
The authors would like to thank the Dean, D.Y.Patil University
School of Medicine, Navi Mumbai, India, for permission to
publish the study.
Approval of Institutional ethics committee sought before com-
mencing the study. Consent of each patient included in the study
taken on admission to the hospital.
Funding
This study received no fund
Conflict of interest
The authors declared that this project was done independently
without any conflict of interest.
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COMPARATIVE STUDY BETWEEN LAPAROSCOPIC AND OPEN CHOLECYSTECTOMY (STUDY OF 50 CASES)

  • 1. SURGERY | ORIGINAL RESEARCH COMPARATIVE STUDY BETWEEN LAPAROSCOPIC AND OPEN CHOLECYSTECTOMY (STUDY OF 50 CASES) Ketan Vagholkar∗,1, Siddharth Nachane∗ and Suvarna Vagholkar∗ ∗Department of Surgery, D.Y.Patil University school of Medicine, Navi Mumbai-400706. MS. India ABSTRACT Background: Laparoscopic cholecystectomy is a new alternative to the traditional open approach for treating calculous cholecystitis. It is, therefore, necessary to assess the efficacy of laparoscopic cholecystectomy over the open cholecystectomy. Objectives: To compare the surgical outcomes of laparoscopic cholecystectomy with those of open cholecystectomy. Materials and methods: 50 patients diagnosed as symptomatic cholelithiasis proven by radiological investigations were distributed into two groups of 25 each. Group A patients were subjected to laparoscopic cholecys- tectomy, and group B patients underwent open cholecystectomy. The surgical outcomes were studied prospectively. Intraoperative complications and postoperative care parameters were evaluated. Results: Mean age of patients in group A was 46.68±13.6 years, and in the group, B was 42.64±14.1 years. Majority of patients were in the age group of 41 to 60 years. Patients who had diabetes in group B developed wound infections, whereas diabetic patients in group A did not develop any infection. Significant bleeding necessitating blood transfusion occurred in one patient belonging to group B. The duration of postoperative analgesia required was 3.16 days in group A and 5.16 days in group B. The duration of postoperative antibiotics administered in laparoscopic and open cases was 1.48 and 4.8 days, respectively. One of the patients in group A developed a postoperative biliary leak, whereas none in group B had any such complication. The commencement of oral feeds and after that return of bowel movements was earlier in group A than group B. The mean hospital stay was 4.5 days in group A as compared to 6.3 days in group B. Conclusion: Laparoscopic cholecystectomy is superior to open cholecystectomy regarding reduced postoperative discomfort and pain, antibiotic and analgesic requirement, early commencement of oral feeds, and shorter duration of hospitalization. KEYWORDS Laparoscopic, Open, Cholecystectomy, Complications, Comparison Introduction Gallstone disease is one of the most common digestive disease encountered by the general surgeon. This was traditionally dealt Copyright © 2021 by the Bulgarian Association of Young Surgeons DOI:10.5455/IJMRCR.Comparative-study-between-laparoscopic-and-open- cholecystectomy First Received: December 27, 2020 Accepted: January 14, 2021 Associate Editor: Ivan Inkov (BG); 1 Department of Surgery, D.Y.Patil University school of Medicine, Navi Mumbai-400706. MS. India, Email: kvagholkar@yahoo.com with by open cholecystectomy. Although open cholecystectomy has been performed with minimal morbidity and mortality, the search for better alternatives continued. The advent of minimal access surgery revolutionised the treatment of gallstone dis- ease. Laparoscopic cholecystectomy was quickly picked up all over the world for treating gallstone disease. Patients preferred laparoscopic technique as it involved significantly less morbid- ity and shorter hospital. Growing experience in laparoscopic cholecystectomy has made the procedure safe. However, some surgeons still suggest that serious complications, particularly bile duct injuries, are significantly higher during laparoscopic cholecystectomy resulting in higher morbidity and occasionally mortality. Open cholecystectomy is still performed in various Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 2. countries from the developing world. However, one cannot deny that a surgeon has to be well-versed with the technique of open surgery as open surgery continues to be the salvage for pre- venting serious complications during complicated laparoscopic cholecystectomy. The present study attempts to compare and contrast laparoscopic cholecystectomy with open cholecystec- tomy. Aims and objectives: The study aims at comparing laparoscopic cholecystectomy and open cholecystectomy concerning: 1. Blood loss during surgery. 2. Complications, including bile duct injuries. 3. Antibiotic and analgesic requirements. 4. Postoperative pain. 5. Duration of hospital stay. Materials and methods: The study protocol was approved by the institutional ethics com- mittee before commencing the study. Fifty patients diagnosed as symptomatic cholelithiasis proven by radiological investiga- tions presenting to a single surgical unit in an urban teaching hospital from January 2017 to December 2017, were distributed into two groups of 25 each. Twenty-five patients in group A un- derwent laparoscopic cholecystectomy, and 25 patients in group B underwent open cholecystectomy. Inclusion criteria: All patients with symptomatic gallstone disease proven by radi- ological investigations. Exclusion criteria: 1. History of investigations suggestive of choledocholithiasis. 2. History of previous abdominal surgery. 3. Conversion of laparoscopic to open cholecystectomy be- cause of difficult anatomy and technical difficulties. On admission to hospital, a detailed clinical history was ob- tained from all the patients. The physical examination followed by blood tests were done. Patients were explained in detail both the options of cholecystectomy while obtaining written informed consent. Patients were equally distributed into two groups based on odd or even last digit of their indoor medical record number. Group A, in which patients underwent laparoscopic cholecys- tectomy, and group B patients underwent open cholecystectomy. All patients were kept nil strictly orally overnight before surgery. Perioperative antibiotics were administered, comprising of injec- tion ceftriaxone 1 gm in three doses. Antibiotics were continued in patients who developed surgical site infections. A nasogastric tube was placed in all patients after induction of general anaes- thesia to prevent the dilated stomach from obscuring the field of vision. The nasogastric tube was removed on the evening of the day of surgery. All the operations in both group A and group B were performed by the first author. Patients were discharged from the hospital after they passed normal stools. Pain in the postoperative period was rated by each patient by using a visual analogue scale from 0 to 10. The data evaluated included patient demographics, laboratory results, operative findings, postopera- tive complications, the severity of postoperative pain, duration of antibiotic and analgesic administration, and length of hospital stay. Laparoscopic cholecystectomy Position The patient was placed in the supine position with a 15º head high to improve the respiratory function. Primary 10mm port was introduced through the sub-umbilical region by the open method. Another 10 mm port was placed in the epigastrium. Two 5mm ports were placed laterally, one in anterior axillary line and another in the midclavicular line. The anterior axillary line port was used to pass a grasper which holds and pushes the gallbladder and liver superiorly. In contrast, the midclavicular port was used to give counter traction by holding the Hartmann’s pouch laterally with a grasper during dissection. The gallbladder was dissected as per standard technique. This included adhesiolysis between the gallbladder and the omentum. Cystic duct and artery were identified and skeletonized before clipping. The gallbladder was dissected free from the cystic plate. Adequate haemostasis was achieved. The specimen was retrieved by placing it in the plastic bag through the sub umbilical port. The 10 mm port sites were closed with 1-0-prolene whereas the skin was approximated with 3-0 monocryl. Drains were kept in the subhepatic space only when satisfactory haemostasis could not be achieved and in cases wherein extensive dissection was carried out. Patients were allowed a liquid diet on the evening of surgery. Open cholecystectomy Position Patient was placed in the supine position with a slight elevation of the head end. Incision: The Kocher’s right subcostal incision was made in all patients belonging to the open group. The gallbladder was appropriately exposed after packs being placed on the hepatic fixture, duode- num, and liver. Gallbladder found to be distended emptied by aspirating the bile using the syringe. Fundus first method was adopted in 25 patients. A subhepatic tube drain was kept in all patients. Skills staples were removed on 10th postoperative day. Results Fifty patients undergoing cholecystectomy were studied after being divided into two groups, namely group A, in which 25 patients underwent laparoscopic cholecystectomy and group B, in which 25 patients underwent open cholecystectomy. 1. Age The mean age of patients in group A was 46.68±13.6 years, and group B was 42.64±14.1 years. Majority of pa- tients were in the age group 41 to 50 across both groups A and B. (Table 1) these observations did not impact surgical outcomes. Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 3. 2. Sex Five patients of group A and three patients of group B were males. Among group A, 20 patients and group B, 22 patients were females. 3. Symptomatology The common presenting symptom in both groups A and B was a pain in the right hypochondrium. Three patients in group A and six patients in group B had only right upper quadrant pain. Six patients in group A and six patients in group B had vomited in addition to pain. Sixteen patients in group A and 13 patients in group B had flatulent dyspepsia. None of the patients had jaundice or previous history of jaundice. The multitude of symptoms did not reach statistical significance. (Table 2) 4. Ultrasonography findings All patients in either of the groups underwent abdominal ultrasonography. Solidary calculus was found in 4 patients from group A, and six pa- tients from group B. Multiple stones were seen in 20 and 18 patients of group A and B, respectively. Biliary sludge was found in 2 patients from group A and one patient from group B. (Table 3) The data was found to be statistically significant. 5. Co-morbid Conditions Six patients in group A and seven patients in group B had diabetes. (Table 4) Though the observation was not found to be statistically significant. Five patients in group A and eight patients from group B were hypertensive. (Table 4) This was statistically not significant. 6. Intraoperative complications Significant intraoperative blood loss was defined as ≥ 100 cc, which occurred in only one patient belonging to group B. The patient was hypertensive. The most important intraoperative complication noted was bile spillage due to accidental rupture of the gall bladder seen in one patient in group A. Stone spillage was seen in the same patient in group A and no patient in group B. There was no CBD injury in either group detected on the table. Sub hepatic drains were required for ten patients in group A and 25 patients in group B. Sub hepatic drains were kept in all patients belonging to group B. This observation was statistically significant. (Table 5) 7. Duration of drain placement Sub hepatic drains were kept in all patients in group B and ten patients in group A. The duration of drains kept was 0.96±1.2 days in group A, and 3.16±1.2 days in group B. (Table 5) The duration was signif- icantly lower in group A patients. 8. Pain score and medication The pain score on a visual ana- logue scale (VAS) was less in group A patients as compared with VAS score in group B for all the three days. (Table 6) The duration of postoperative analgesia in group A was 3.16±2.41 days compared to 5.16±1.8 days in group B. (p=0.002). The difference in values was statistically sig- nificant 9. Postoperative outcomes No surgical site infection was seen in group A patients, whereas 3 patients belonging to group B developed surgical site infection.(p=0.297) One patient from group A developed a biliary leak which was detected within 48 hours and managed by ERCP with stenting. None of the group B patients developed any biliary leak. Peri- operative antibiotics were given (1.48±1.8 days) to group A patients compared to 4.8±0.7 days in group B patients. (Table 7) 10. Postoperative recovery Group A commenced oral feeds in 2.36±1.2 days while group B patients commenced oral feeds in 3.16±0.7 days (significant, p = 0.010). Bowel movements regained normalcy in 3.52±1.8 days in group A compared to 4.76±1.1 days in group B (significant, p = 0.005). The duration of hospital stays was4.48±2.9 days in group A and 6.32±2.1 days in group B. The difference in the duration of stay between the two groups was statistically significant (p = 0.015). (Table 8) Table 1 Age distribution and range Group N Mean Std. Devia- tion A 25 46.68 13.698 B 25 42.64 14.124 Age (Years) Group A Group B <=30 4 6 31-40 4 6 41-50 10 10 51-60 2 2 61-70 5 1 Total 25 25 (Unpaired t-test) P value = 0.310 (Not Significant) Table 2 Clinical Presentation Clinical Presentation Group A Group B Only Pain in RUQ 3 6 Vomiting 6 6 Dyspepsia 16 13 Pain with other Symp- toms 25 25 P value >0.05 (chi square test) Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 4. Table 3 Ultrasonography findings USG Findings Group A Group B Solitary Calculus 7 6 Multiple Cal- culi 16 18 Sludge 2 1 Total 25 25 P value >0.05 (chi square test) Discussion Open cholecystectomy has always withstood the test of time as a standard of care for gallstone disease. With the advent of mini- mal access surgery, open cholecystectomy for gallstone disease has become a less preferred technique. Laparoscopic cholecystec- tomy has now become the gold standard of care. However, one has to accept that laparoscopic surgery also has its limitations, wherein open surgery remains the only salvage. The experi- ence with open surgery in the younger generation of surgeons is dwindling rapidly almost to the verge of extinction. Many times, difficult dissections make laparoscopic cholecystectomy a dangerous procedure. In such circumstances, it is always safe to convert to an open procedure. [1] Hence the present study was carried out in order to refresh the pros and cons of open surgery as compared with laparoscopic surgery. With the advent of minimal access surgery, younger age group patients prefer laparoscopic cholecystectomy over the open procedure. [1] In the present study, most patients in both groups were in the age group of 41 to 50 years. The efficacy of laparoscopic cholecystectomy in various age groups was com- pared with the open procedure. However, the results were not statistically significant. Older age group patients also prefer to undergo laparoscopic cholecystectomy. [2] Studies have shown that they have better outcomes as well as reduced morbidity due to quick recovery. [1, 2] Majority of patients in the present study were females. La- paroscopic cholecystectomy in male patients is associated with a high conversion rate. Therefore, it is considered a risk factor for conversion. [3, 4, 5] Patients selected in each group presented with symptoms of pain in the right hypochondrium, vomiting, and dyspepsia. All these patients had a chronic indolent course. The symptomatol- ogy of the disease presented did not influence the surgical out- comes irrespective of the type of procedure performed (p>0.05). The diagnosis of gallstones was confirmed in all the patients by abdominal ultrasonography. Sixteen patients in group A and 18 patients in group B had multiple calculi. Seven patients in group A and six patients in group B had a solitary calculus. Two pa- tients in group A and one patient in group B had biliary sludge. The severity of stone disease by stone load did not influence the nature and outcome of the surgical technique. [6] Diabetes, hypertension, and ischemic heart disease are the common comorbid medical conditions associated with advanced age. [7, 8] Diabetes is usually associated with high cholesterol Table 4 Co-morbid conditions (Diabetes Mellitus & Hyperten- sion) Diabetes Mel- litus Group A Group B Total No 19 (76%) 18 (72%) 37 (74%) Yes 06 (24%) 07 (28%) 13 (26%) Total 25 (100%) 25 (100%) 50 (100%) X2 = 0.014 DF=1 P value =0.747 (Not Sig- nificant) (chi square test) Hypertension Group A Group B Total No 17 (68%) 20 (80%) 37 (74%) Yes 08 (32%) 05 (20%) 13 (26%) Total 25 (100%) 25 (100%) 50 (100%) X2 = 0.936 DF=1 P value =0.333 (Not Sig- nificant) (chi square test) which predisposes to the development of gallstones. The pecu- liarity of diabetic patients is that the severity of gallstone disease is invariably missed due to masking of symptoms. [9, 10, 11] Diabetic patients are more prone to septic complications, in- cluding surgical site infections, thereby contributing to the mor- bidity in these patients. A minimally invasive approach, there- fore, is of great advantage as it reduces the chances of septic complications.[9, 10, 11] Open approach involves a bigger inci- sion and puts increased demand on the wound healing process, which in diabetic patients is seriously compromised. As a result, diabetic patients develop a multitude of complications ranging from intra-abdominal sepsis to surgical site infections. Therefore, laparoscopic cholecystectomy has a major advantage over the open method in diabetic patients. In the present study, seven patients in group B and six patients in group A had diabetes. Three patients who developed surgical site infections had dia- betes and belonged to group B. None of the patients in group A developed surgical site infections. However, as the sample size was small, statistical significance could not be determined. Hypertension is another comorbidity which poses a chal- lenge. [12, 13] Adequate preoperative control of hypertension is mandatory. Despite good control yet intraoperative complica- tions can occur during laparoscopic cholecystectomy requiring conversion to open. In the present study, three diabetic patients in group B developed infection out of which 2 had a history of hypertension. 8 out of 25 patients in group B were hypertensive. One of these patients developed significant intraoperative bleed- ing (>100cc) requiring a blood transfusion. In group A patients, five patients had hypertension, but none of them developed any Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 5. Table 5 Intra-Operative Complications Intra-operative Findings Group A Group B Significant Blood Loss(>100cc) 0 1 Blood replaced 0 1 Bile/stone Spillage 1 0 Drains used 10 25 Intraoperative Complications (Blood transfusion) Group A Group B Total No 25 (100%) 24 (20%) 49 (98%) Yes 00 (0%) 01 (04%) 01 (02%) Total 25 (100%) 25 (100%) 50 (100%) X2 = 1.020 DF=1 P value =0.312 (Not Significant) (chi square test) Intraoperative Complications (Drain) Group A Group B Total No 15 (60%) 00 (00%) 15 (30%) Yes 10 (40%) 25 (100%) 35 (70%) Total 25 (100%) 25 (100%) 50 (100%) X2 = 21.429 DF=1 P<0.001(Significant) (chi square test) Group N Mean SD ‘p’ value Significance Duration of the drain (days) A 10 0.96 1.274 <0.001 Significant B 25 3.16 1.463 (Unpaired T-test) bleeding. As the process of laparoscopic technology evolves, better methods of achieving haemostasis are available. This has reduced the chances of bleeding. As a result, the conversion rate due to bleeding has decreased significantly. Harmonic scalpel and argon B laser technologies have empowered surgeons to achieve excellent haemostasis at the time of surgery. Ischemic heart disease is a common accompaniment of gall- stone disease, especially in the older age group of patients.[12, 13] Multiple reports have suggested the high incidence of car- diopulmonary complications in patients undergoing biliary type surgery.[14,15,16] Various intraoperative issues can alter the nor- mal surgery course, both during laparoscopic and open surgery. Intraoperative bleeding is one such complication. A magni- fied appearance in laparoscopic cholecystectomy enables better haemostasis to be achieved. Judicious use of bipolar cautery will suffice in the majority of situations. Due to accidental perforation spillage of bile occurred in one patient undergoing laparoscopic cholecystectomy. Bile spillage due to accidental perforation during laparoscopic cholecystectomy usually occurs while dis- secting the gallbladder from the inferior surface of the liver. [17] It is essential to maintain adequate traction on the gallbladder while dissecting the plane between the gallbladder and the liver. [18] The surgeon needs to suck all the spilt bile followed by saline irrigation before proceeding. Stone spillage is another consequence of accidental gall blad- der perforation during dissection. [17, 18] In the present study, one patient undergoing laparoscopic cholecystectomy had stone spillage during surgery due to accidental perforation of the gall bladder. Whenever stones are spilt, they need to be meticulously picked up and removed. To prevent spillage, it would be a safe practice to take an intracorporeal stitch to close the site of per- foration. [18] This would prevent further leakage of bile and spillage of stones. Dropped stones in the peritoneal cavity can elicit an inflammatory reaction leading to an abscess. In the present study, such complications did not occur. Whenever there is extensive tissue dissection, there is oozing of blood and tissue fluid. If this fluid accumulates, it can lead to the formation of an abscess. Therefore it is a safe practice to place a closed tube drain at the operative site to drain such collections. Another advantage of placing drains is the early diagnosis of bile leak which could either be from the inferior surface of the liver due to damage to superficial small biliary ductules, or even the hepatic or common bile duct in complicated cases. The advantage of picking up on bile leak early undoubtedly outweighs the suspense created by a wait and watch policy in patients wherein drains were not kept. [19, 20] Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 6. Table 6 Pain Score and Medication: Group A (n=25) Group B (n=25) ‘p’ value Significance VAS 1 5.28±0.792 7.52±1.005 <0.001 Significant VAS 2 3.92±0.909 6.08±0.909 <0.001 Significant VAS 3 2.84±1.143 4.84±0.850 <0.001 Significant Postoperative analgesia required (days) 3.16±2.410 5.16±1.818 0.002 Significant (Unpaired t-test) Table 7 Postoperative outcomes Postoperative Complications Group A Group B Wound Infection 0 3 Biliary Leak 1 0 Perioperative Antibiotics (days) 1.48 4.8 Postoperative Complications (wound infection) Group A (n=25) Group B (n=25) Total Nil 25 (100%) 22 (88%) 47 (94%) Yes 00 (00%) 03 (12%) 03 (06%) Total 25 (100%) 25 (100%) 50 (100%) X2 = 1.087 DF=1 P value =0.297 (Not Significant) (chi square test) Postoperative Complications (Biliary leak) Group A (n=25) Group B (n=25) Total Nil 24 (96%) 25 (100%) 49 (98%) Yes 01 (04%) 00 (00%) 01 (02%) Total 25 (100%) 25 (100%) 50 (100%) Group A (n=25) Group B (n=25) ‘p’ value Significance Perioperative antibiotics (days) 1.48±1.828 4.80±0.707 <0.001 Significant Unpaired t test In the present study, a 14F Ryle’s tube was placed in 10 pa- tients undergoing laparoscopic cholecystectomy. Because they had a difficult dissection with the likelihood of leakage whereas, in the open group, intra-abdominal drains were kept in all 25 patients. In the group of patients who underwent laparoscopic cholecystectomy, a postoperative bile leak was detected in one patient who immediately underwent ERCP and stenting. The use of drains has always been a contentious issue. Opponents of this concept attribute it to a higher incidence of ascending infec- tion. [20] However, the present study suggests that it is a safe practice devoid of complications to place a drain in the hepatore- nal pouch, especially in cases which are technically demanding. [21, 22, 23, 24, 25] Pain is a very subjective and complex mechanism with physi- cal, emotional, and cognitive components. [26] It is a subjective concept which is difficult to quantify. Every individual has a dif- ferent threshold for pain. Hence the need for anaesthesia differs from person to person. Pain has a multitude of effects on the human body. Pulmonary complications may develop rapidly in patients suffering from severe pain. In the present study, the vi- sual analogue scale (VAS) score was used to assess postoperative pain. Visual Analogue Scale (VAS) is a psychometric response scale. VAS provides an objective method for assessment with better compliance and easy reproducibility. [27, 28, 29] In the present study, the pain was assessed on three consecutive days with the help of VAS. It was observed that on day 1, the pain was significantly less in patients undergoing laparoscopic chole- cystectomy compared to open cases. The same observation was noted on day 2 and day 3. The advantage of this observation was that the need for analgesia was significantly less in patients undergoing laparoscopic cholecystectomy—analgesic or pain control protocol used in the present study comprised of parac- etamol infusion. In the group who underwent open surgery, analgesics were administered for 48 hours, followed by oral drugs. Analysis of these observations yielded statistically sig- nificant results, thereby proving the superiority of laparoscopic cholecystectomy over open surgery. Cholecystectomy, whether open or laparoscopic, is classified as a clean-contaminated procedure. However, in bile and stone spillage, it can best be reclassified as a contaminated procedure. Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 7. Table 8 Postoperative recovery Group A (n=25) Group B (n=25) ‘p’ value Significance Oral feed day 2.36±1.827 3.16±0.746 0.01 Significant Bowel habits returned day (passage of stool) 3.52±1.873 4.76±1.012 0.015 Significant Hospital stay 4.48±2.974 6.32±2.135 0.015 Significant (Unpaired t-test) Bile in gallbladder containing stones is always potentially in- fected. Hence spillage of this bile can increase the chances of infection. It is a good practice to administer antibiotics for all clean-contaminated procedures. [30] In the present study, peri- operative antibiotics were administered to patients belonging to both groups. A combination of ceftriaxone and amikacin was used. Check dressing of the surgical wounds was done after 48 hours. None of the patients belonging to the laparoscopic cholecystectomy group had an infection. However, three pa- tients in the open group developed surgical site infections. A swab from the site was taken from infected cases and was found to grow staphylococcus aureus. These patients were continued on a course of antibiotics for five days. One of the patients had partial wound dehiscence requiring secondary suturing, whereas the other two healed by regular dressings. Therefore the observation that there is a lesser requirement of antibiotics in laparoscopic cases was substantiated in the study. Wound infection as a complication following any surgery is related to a multitude of factors which can be classified as patient-related factors, surgical factors, and pathological factors. Patient-related factors include the patient’s nutritional status and comorbid medical conditions. In the present study, all three patients who developed wound infection had diabetes. Surgical factors include meticulous skin preparation protocols, diligent surgical techniques, achieving good haemostasis, and judicious use of drains. Despite taking all precautionary care, yet infec- tions do develop, which can be attributed to difficult dissection and prolonged duration of surgery. [29, 30] In the present study, comorbid factors played a role in developing a wound infection. Patients suffering from empyema of the gallbladder have an in- creased chance of developing sepsis. Patients with an obstructed biliary system can also develop complications. Laparoscopic cholecystectomy under smaller incisions significantly reduces the potential of wound infection. However complex infections do develop at the sub umbilical port site in laparoscopic chole- cystectomy. These are resistant to treatment as they are caused by organisms such as atypical mycobacteria. Cleaning the um- bilicus before the surgery is, therefore of utmost importance in preventing port site infections. Damage to the extrahepatic biliary passages, especially the common bile duct is a catastrophic laparoscopic cholecystec- tomy complication. Such complications are usually created by surgeons who are in the early stages of the learning.[31] It is therefore prudent on the part of the surgeon to ensure that he is fully aware and competent enough to identify and manage iatrogenic biliary tract injuries. An adequate number of open procedures should have been performed before attempting la- paroscopic procedures. This gives a broad overview of the ma- jority of anatomical variations in the blood supply and ductal anomalies of the extrahepatic biliary passages. Iatrogenic in- juries usually present in three ways depending upon when they are diagnosed. [31, 32] Some of these injuries are identified during the surgery itself. This requires immediate conversion to an open procedure in order to assess the exact extent of the injury. If the injury hap- pens to be a rent in the CBD, a T-tube should be placed in the CBD and further management can be carried out accordingly. However, if the injury involves a significant length of the CBD or is accompanied by a vascular injury, the best option is a biliary enteric procedure. If the injury is suspected or diagnosed in the early postop- erative period by way of a bile leak in the drain or as jaundice, then ERCP is mandatory. If ERCP shows that the continuity of the CBD is maintained, then stenting is therapeutic.[33] How- ever, if the CBD appears to be transected entirely manifesting as jaundice in the early postoperative period, then a judicious and logical diagnostic algorithm needs to be followed. Percu- taneous transhepatic drainage needs to be performed to drain the bile. This should be kept for a period of 8 to 12 weeks. This will allow inflammation in the porta hepatis to have completely settled and the process of fibrosis having been completed or the intensity reduced. [34] The septic implications need to be attended by a combination of a subhepatic drain introduced by interventional radiology or by open method accompanied by an adequate course of antibiotics. Twelve weeks would be a safe period to be allowed before surgical intervention can be contemplated. Either a PTC or an MRCP should be performed to assess the final status of the CBD. This should be followed by an elective biliary enteric anastomosis preferably hepaticoje- junostomy. The third category of patients with biliary tract injury usually presents with a biliary stricture—the average time frame for this complication to develop ranges from 6 months to 1 year. The development may be hastened if there is concomitant vascu- lar injury. [35] Presence of a vascular injury has a significant negative outcome on definitive surgery. As per Strasburg clas- sification, a working algorithm is formulated to manage such injuries depending on its severity. What is important in such cases is to rule out the chance of it being a malignant stricture. Therefore good imaging in the form of ERCP or MRCP is manda- tory to study the proximal extent of the stricture. The status of the liver also needs to be assessed as these patients can de- velop complications of chronic cholestasis with infection and rarely secondary biliary cirrhosis compromising liver function at the time of the definitive procedure. [36]Various surgical options are available dictated by the level of the stricture. Hep- atico jejunostomy performed on a normal hepatic duct will have the best surgical outcome because of its superior vascularity as compared to the CBD. In the rare event of a stricture at the confluence, the confluence may have to be sacrificed, exposing the right and left hepatic ducts. A double hepaticojejunostomy should be performed comprising of a right hepaticojejunostomy and left hepaticojejunostomy with the same loop of jejunum placed over a short distance, resulting in a tension-free anasto- mosis. The incidence of biliary tract injuries during laparoscopic cholecystectomy has significantly reduced over time due to im- Ketan Vagholkar et al./ International Journal of Medical Reviews and Case Reports (2021) 5(1):189-198
  • 8. provisation in both surgical technology and technique. However, the incidence of such injuries continues to be higher in laparo- scopic surgery as compared to open surgery. A surgeon should follow the safety dictum “prevention is better than cure”. In the context of biliary tract injuries, this envisages conversion to open surgery anticipating the difficulty in dissection, performing such procedures under the supervision of an experienced surgeon initially before starting at an individual level and finally close monitoring of patients post-operatively. In the present study, all surgeries were performed by the principal author, who has been well experienced in biliary surgeries, including salvage procedures for biliary tract injuries. No major complications arose in either group, except for one patient in the laparoscopic group who developed a bile leak in the postoperative period. An ERCP was performed, which revealed a small leak from the CBD, which was immediately stented. The leak stopped in 48 hours with no septic complications. The stent was removed after three weeks. Various studies have observed an increased risk of bile duct injuries after laparoscopic cholecystectomy (1.1%) compared to open surgery (0.51%).[31, 33, 35] Patients always prefer to undergo a procedure which ensures speedy recovery. As surgery has evolved over the years, so also has the rapidity of postoperative recovery. Laparoscopy enables quick recovery as compared to open procedures. La- paroscopy involves less mechanical handling of tissues, more accurate dissection, less exposure of abdominal contents, mini- mal homeostatic imbalances and a better metabolic response to the surgery. [35, 36] As a result recovery of the gastrointestinal function is quick, enabling early commencement of oral feeds. In the present study patients who underwent laparoscopic chole- cystectomy commenced oral feeding by second postoperative day compared to those who underwent open surgery which started oral feeds by the fourth postoperative day. This con- formed with other studies. Early commencement of oral feeding is an important, satisfying factor for the patient who has under- gone surgery. It reduces the hospital stay as compared to open procedures which were observed in the present study and were statistically significant. Therefore, there is higher patient com- pliance and acceptance of the procedure. In the present study, the mean hospital stay was 4.5 days for laparoscopic cholecys- tectomy and 6.3 days for open procedures. The results were statistically significant (p<0.05). However, it needs to be ex- plained to the patient that in the rare event of a complication, the hospital stay may be prolonged and may necessitate conversion to open surgery and ancillary procedures. [36] The strength of the study is that both procedures were eval- uated. The limitation of the study was the smaller sample size. Larger studies will strongly support the superiority of laparo- scopic cholecystectomy over open cholecystectomy. Conclusion Laparoscopic cholecystectomy is the gold standard for treating gallstone disease for several proven reasons. 1. Shorter duration of hospital stays increases patient accept- ability allowing patients to resume routine activities earlier. 2. Concerning the surgical aspects, it decreases the morbid- ity associated with the surgery significantly as the dissec- tion’s quality is better, chances of wound infection are less, thereby precluding prolonged antibiotic usage. Concerning the recovery phase, there is a significant decrease in postop- erative pain. As a result, there is a decrease in the duration of analgesia required. Oral feeds are commenced early, thus achieving early recovery to normalcy. 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