Laparoscopic cholecystectomy has been the standard procedure for gallbladder removal since the 1990s. Recently, single incision laparoscopic cholecystectomy (SILC) has been developed to further reduce invasiveness. While technically challenging, SILC offers benefits like less pain, faster recovery, and better cosmetic outcomes compared to standard laparoscopic cholecystectomy. The document presents a study protocol to evaluate the benefits of SILC with intraoperative cholangiography, including safety, reduced invasiveness, and ability to manage unexpected bile duct issues. The prospective randomized study will compare outcomes of SILC with cholangiography to standard techniques in 100 patients. Results will help determine if S

1. INTRODUCTION
Laparoscopic cholecystectomy (LC) has been the gold standard for removal of
the gallbladder since the early 1990. As technology has progressed; surgeons have
begun to develop less invasive methods for this commonly performed procedure
(Rawlings et al., 2010). (1)
Recently, technical improvements have allowed many minimally invasive
procedures to be adapted to a reduced number of incisions, and in many cases only one
incision, single incision surgery is most common (Joseph et al., 2012).(2) Navarra first
described the laparoscopic removal of a gallbladder through multiple ports in a single
periumbilical incision in 1997 (Hall et al., 2012).(3)
Single incision laparoscopic cholecystectomy also goes other terminologies,such
as
transumbilical
Laparoscopic
cholecystectomy,
single
port
laparoscopic
cholecystectomy, natural orifice transumbilical surgery (NOTUS) cholecystectomy and
laparoendoscopic single site (LESS) cholecystectomy (osuagwu, 2013).(4)
Although single incision laparscopic cholecystectomy (SILC) remains technically
challenging for most surgeons, it can offer potential advantages, including less
postoperative pain, shorter recovery time, improved cosmetic outcome, and higher
patient satisfaction. Recent randomized controlled trials showed that SILC is a safe
procedure with better cosmetic results as compared to conventional LC (Sato et al.,
2013).
(5)
The indications for single incision laparoscopic cholecystectomy include the
following:Biliary colic , Biliary dyskinesia , Gallbladder polyp larger than 1 cm ,
Porcelain gallbladder, In any single incision laparscopic cholecystectomy, it is
1

2. important to maintain a low threshold for conversion to a standard laparoscopic
cholecystectomy or open cholecystectomy ( Bhandarkar et al., 2011 ) .(6)
The contraindications of single incision laparoscopic cholecystectomy include
the following: Absolute contraindications for single-port cholecystectomy are
pregnancy and an American Society of Anesthesiologists (ASA) classification of 3(A
patient with severe systemic disease) or 4 (A patient with severe systemic disease that is
a constant threat to life). Relative contraindications include acute cholecystitis and
previous upper abdominal surgical procedures. These patients should not be considered
for single-port cholecystectomy, and a standard 4 ports laparoscopic cholecystectomy
should be performed instead (Mutter et al., 2008). (7)
The complications of single incision laparoscopic cholecystectomy include the
following: Minor complications, treated conservatively, wound infection, umbilical
abscess, seroma, skin laceration, subumbilical hematoma, perihepatic fluid collection
and ileus. Conservative treatment was installed for all these complications and consisted
of a wait and see policy or administration of antibiotics. Major complications, The most
feared complication after laparoscopic cholecystectomy is bile duct injury. Other major,
more frequent complications are haemorrhage, subhepatic abscesses and those lesions
that require surgical intervention or stenting ( Fransen et al., 2012). (8)
Operative Procedure: skin and subcutaneous tissues were passed through with a
20 mm transverse incision from the umbilicus in 120 subsequent patients. Fascia was
slinged with notched clamps, and the abdomen was entered using a transverse fascia
incision. A port manufactured for SILS (SILS port Covidien©) was placed. Intraabdominal pressure was elevated to 13 mmHg with insuflation. The abdomen was
entered above the specific port with two (5 mm) and one (12 mm) trochars. A 5 mm,
30° laparoscope was used. The gallbladder was suspended using the grasper. The cystic
2

3. artery was dissected, taking special care with the dissection of the cystic duct. The
relationship between the main bile duct and the cystic duct was displayed. The artery
and the cystic duct were clipped with a medium clip from a 12 mm trochar divided with
endoscopic scissors. The gallbladder was separated from the liver using a hook cautery
and removed from the incision line. An endobag was not used in any of the patients. A
laparoscopic exploration was then performed to ensure that no intraoperative
complications occurred, such as bleeding or biliary leakage. After removing the port and
releasing the residual carbon dioxide, the fascia defect was closed with loop prolene.
The skin was sutured in an intradermic fashion using rapid Vicryl (Yilmaz et al., 2013).
(9)
The use of routine intraoperative cholangiography (IOC) is widely practiced
during conventional four ports laparoscopic cholecystectomy (4PLC) to confirm biliary
anatomy and allow for immediate management of unexpected choledocholithiasis (Yeo
et al., 2011). (10)
The use of IOC during SILC is, however, limited by the technical difficulties of
the procedure through a single incision or, in some IOC systems, requirement of
additional skin incision (Shibao et al., 2013). (11)
The indications for intraoperative cholangiography (IOC) include a clinical
history of jaundice, pancreatitis, elevated bilirubin level, abnormal liver function test
results, increased amylase levels, a high lipase level, or dilated common bile duct on
preoperative ultrasonography. Although these clinical features are widely accepted as
indications for IOC, they have not been tested for their ability to predict
choledocholithiasis (Livingston et al., 2005). (12)
3

4. SUBJECTS AND METHODS:
1- TECHNICAL DESIGN:
Study design:
* A prospective simple randomized clinical trials will be used in carrying out the study.
Study setting:
* This study will be conducted in Zagazig University Hospitals, as it is one of the major
curative facilities in Sharkia Governorate with high patients rate.
Population or subjects:
* Patients with calcular cholecystitis in General Surgery Department.
Data collection tools:
* Laboratory investigations, Ultrasound or (ERCP and MRCP when indicated)
Inclusion and exclusion criteria:
*Any patient doing single incision laparoscopic cholecystectomy with
cholangiography during the study period.
Sampling:
* Sample size will be
patients .
* Sample selection: simple randomized sample.
2-OPERATIONAL DESIGN:
4

5. Process:
Informed consent regarding the study will be taken from every patient.
Evaluation of the single incision laparoscopic cholecystectomy with
intraopartive cholangiography technique.
We will withdraw from the study by detection of the benefits of single
incision laparoscopic cholecystectomy with intraopartive cholangiography.
Time line:
Practice
8 months parallel with the review
Statistic
1 month
Discussion
1 month
Obstacles:
1. There will be expected difficulty in following up the patients after
discharge from the hospital. We can solve this obstacle by taking patients'
number telephones and addresses.
2. There will be expected missing of one of the benefits of single incision
laparoscopic cholecystectomy with intraopartive cholangiography e.g.
cosmesis. We can solve this by following the patient well after the
operation.
3- ADMINISTRATIVE DESIGN:
* Approval will be obtained from ethical committee in Faculty of Medicine,
Zagazig University, and from patients included in the study.
5

6. 4- STATISTICAL DESIGN:
* Data entry and analysis will be done using SPSS 10.0 statistical software
package.
RESULTS:
* The results will be assessed and statistically analysed to detect the benefits of
single incision laparscopic cholecystectomy with cholangiography.
CONCLUSION:
* We expect that the benefits of single incision laparscopic cholecystectomy with
cholangiography that it can offer potential advantages, including less invasive, less
postoperative pain, shorter recovery time, improved cosmetic outcome, higher patient
satisfaction, confirm biliary anatomy and allow for immediate management of
unexpected choledocholithiasis.
RECOMMENDATIONS:
* If single incision laparoscopic cholecystectomies with cholangiography requirements
are easy available it is better to use the new technique.
* Experienced Laparoscopic surgeons tend to operate on more operations with single
incision laparoscopy.
RATIONAL:
* Gall stones are a major problem and cholecystectomy is the proven treatment of
this problem so we try to find the least invasive and more benefit techniques.
6

7. * Single incision laparoscopic cholecystectomy in less invasive with more
benefits.
* So, we will study single incision laparoscopic cholecystectomy with
cholangiography benefits.
RESEARCH QUESTION:
* What are the benefits of single incision laparscopic cholecystectomy with
cholangiography?
AIM:
* To detect the short term outcome of single incision laparscopic
cholecystectomy with cholangiography and see what is the benefits?
OBJECTIVES:
* The objectives in this study can be summarized in the following points:
1. To detect the safety of single incision laparscopic cholecystectomy with
cholangiography.
2. To detect the benefits of single incision laparscopic cholecystectomy.
3. To detect the role of intaoperative cholangiography.
7

8. REFERANCES
1) Rawlings A, Hodgett S, Matthews B, Strasberg S, Quasebarth M and Brunt
M (2010): Single-Incision Laparoscopic Cholecystectomy: Initial Experience with
Critical View of Safety Dissection and Routine Intraoperative Cholangiography. J
Am Coll Surg; 211:1–7.
2) Joseph M, Phillips M, Farrell T and Rupp C (2012): Single Incision
Laparoscopic Cholecystectomy Is Associated With a Higher Bile Duct Injury
Rate. Ann Surg; 256:1–6.
3) Hall H, Dennison A, Bilku D, Metcalfe M and Garcea G (2012): Single
Incision Laparoscopic Cholecystectomy. Arch Surg. 7 147(7):657 666.
4) Osuagwu C (2013): A Review of Randomized Controlled Trials Comparing
Single Port Laparoscopic Cholecystectomy with Conventional laparoscopic
Cholecystectomy. World Journal of Laparoscopic Surgery; 6(2): 93_97.
5) Sato N, Shibao K, Akiyama Y, Inoue Y, Mori Y, Minagawa N, Higure A and
Yamaguchi k (2013): Routine Intraoperative Cholangiography During SingleIncision Laparoscopic Cholecystectomy: a Review of 196 Consecutive Patients. J
Gastrointest Surg ; 17:668–674.
6) Bhandarkar D, Mittal G, Shah R, Katara A and Udwadia T (2011): Singleincision laparoscopic cholecystectomy: How I do it? J Minim Access Surg; 7(1):
17–23.
7) Mutter D, Leroy J, Cahill R and Marescaux J (2008): A simple technical
option for single-port cholecystectomy. Surg Innov. Dec; 15(4):332-3.
8) Fransen S, Stassen L and Bouvy N (2012): Single incision laparoscopic
cholecystectomy: A review on the complications. J Minim Access Surg.; 8(1): 1–
5.
8

9. 9) Yilmaz H, Alptekin H, Acar F, Ciftci I, Tekin A and Sahin M (2013):
Experiences of Single Incision Cholecystectomy: Int. J. Med. Sci.; 10(1):73-78.
10)
Yeo D, Mackay S and Martin D (2011): Single-incision laparoscopic
cholecystectomy with routine intraoperative cholangiography and common bile
duct exploration via the umbilical port. Surg Endosc; 26:1122–1127.
11)
Sato N, Shibao K, Akiyama Y, Inoue Y, Mori Y, Minagawa N, Higure A
and Yamaguchi k (2013): Routine Intraoperative Cholangiography during
Single-Incision Laparoscopic Cholecystectomy. J Gastrointest Surg; 17:668–674.
12)
Livingston EH, Miller JA, Coan B and Rege RV (2005): Indications for
selective intraoperative cholangiography. J Gastrointest Surg.; 9(9):1371-7.
9