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*Corresponding Author: Dr. Manoj Bhadja, Email: bhadjamanoj@gmail.com
ISSN 0976 ā€“ 3333
RESEARCH ARTICLE
ICLE
Available Online at www.ijpba.info
International Journal of Pharmaceutical & Biological Archives 2017; 8(6): 42-47
A Comparative clinical study of Ksharsutra ligation and Lateral Internal
Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano)
*Dr. Manoj Bhadja1
, Dr. T.S. Dudhamal2
1*
Assistant Professor, Dept. of Shalya Tantra, IPGT&RA, Gujarat Ayurved University, Jamnagar, Gujarat. India
2
Associate Professor & I/c Head
Dept. of Shalya Tantra, IPGT&RA, Gujarat Ayurved University, Jamnagar, Gujarat. India
Received 30 Sep 2017; Revised 20 Oct 2017; Accepted 12 Nov 2017
ABSTRACT
Background: Parikartika which resembles fissure-in-ano described as a complication of various diseases
in Ayurvedic texts such as Vatika jwara, Vatika pakwa atisara, Sahaja arsha, Kaphaja arsha, Arsha
purvarupa, Udavarta, complication of pregnancy (Garbhini), unlawful administration of purgative or
enema (Basti), complication of Vamana and Virechana. As Ksharsutra , proven successful treatment
modality for fistula-in-ano and piles to try its efficacy in chronic fissure-in-ano. Aim: To compare
Apamarga Ksharsutra ligation and Lateral Internal Sphincterotomy (LIS) in the management of
Parikartika (Chronic fissure-in-ano). Materials and Methods: Total 30 patients of Parikartika were
selected and randomly divided in to two Groups (15 in each group). In group-A, Ksharsutra ligation with
maximum possible anal dilatation was carried out while in group-B Lateral Internal Sphincterotomy with
excision of skin tag was carried out under local anesthesia. Relief in symptoms and post operative
complications in subjects were assessed for 4 weeks and follow up period was 1 month. Results: In both
groups, significant results were found individually but difference was statistically insignificant. Duration
required for relief in post- operative pain, bleeding, swelling and wound healing was found more in
group-A (Ksharsutra) than group-B (LIS). Conclusion: Lateral Internal Sphincterotomy produced better
results in compare to Ksharsutra ligation in the management of Parikartika (Chronic Fissure-in-Ano).
Key words: Parikartika, Fissure-in-ano, Ksharsutra , Lateral Internal Sphincterotomy.
INTRODUCTION
In the Ayurvedic texts, Parikartika (cutting pain
in Ano) is described as a symptom of various
disease conditions such as Vatika jwara, Vatika
pakwa atisara, Sahaja arsha, Kaphaj arsha,
Arsha purvarupa, Udavarta, complication of
pregnancy (Garbhini), unlawful administration of
purgative or enema (Basti), complication of
Vamana and Virechana. It was considered as
disease first time in Kashyapasamhita and its
types based on Dosha were also described. This
classification was also followed in
Sharangdharasamhita in medieval period. [1]
Fissure in ano is an elongated ulcer in the long
axis of the anal canal.[2]
Etiology of fissure-in-ano
is primarily constipation with passing of hard
stool and secondary due to many diseases like
chronic amoebic dysentery, diverticulitis, irritable
bowel syndrome, ulcerative colitis etc. The
common site of fissure-in-ano is 6 oā€™clock
(midline posterior) in lower half of the anal canal
which is commonly found in young adults and
after delivery in females. The disease has been
classified into two varieties viz., acute and chronic
fissure-in-ano. Acute fissure-in-ano can be
subsided by conservative treatment but in chronic
cases surgical intervention is needed.[3]
In modern
surgical treatments such as Lordā€™s anal dilatation,
fissurectomy, and sphincterotomy for anal fissure
are suggested but they have their own limitations
like recurrence, incontinence, etc.
Ayurvedic para-surgical procedure, Ksharsutra
ligation, is found successful treatment modality
for anorectal disorders like fistula-in-ano [4]
hemorrhoids, [5]
and chronic fissure-in-ano [6]
but
with limited data. Presently, Lateral Internal
Sphincterotomy (LIS) is considered as gold
standard treatment for chronic fissure-in-ano.[7]
There is a need to compare both treatment
procedures i.e. Ksharsutra ligation and Lateral
Internal Sphincterotomy. Considering all these
factors, present study was planned with aim to
Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of
Parikartika (Chronic Fissure-in-Ano)
Ā© 2010, IJPBA. All Rights Reserved 43
compare Ksharsutra ligation and Lateral Internal
Sphincterotomy in the management of Parikartika
(Chronic fissure-in-ano).
MATERIALS AND METHODS:
Selection of Patients:
The patients of Parikartika (chronic fissure in
ano) were selected from OPD/IPD of study centre
irrespective of age, gender, occupation and
religion. Clinical trial was approved by
Institutional Ethics Committee (ref. no. PGT/7/-
A/Ethics/2014-15/1538 dated 02.09.2014) and
registered in CTRI (Reg. no.
CTRI/2016/02/006679) retrospectively.
Inclusion criteria:
Patients of age group between 17-60 years of
Parikartika (Chronic fissure-in-ano) having
duration more than 6 months were included in the
study.
Exclusion Criteria:
Patients of fissure-in-ano with less than 6 months
duration, chronic fissure-in-ano associated with
piles & fistula, malignancy of anorectum or any
other organs were excluded. Positive cases for
HIV, VDRL, Hepatitis-B and uncontrolled cases
of Diabetes Mellitus and Hypertension were also
excluded.
Diagnostic Criteria:
The patients were diagnosed on the basis of
history, signs and symptoms, local examination
with digital per rectal examination of and feature
of chronic fissure in ano. Digital per rectal
examination was carried out with 2% Xylocaine
jelly to assess the sphincter tone after assessing
the tolerance of pain and consent of patient.
Proctoscopic examination was done after giving
suitable anesthesia at the time of operation to
exclude other anorectal pathologies like piles,
polyp, any growth, etc.
Laboratory Investigations:
Routine Haemogram, B.T., C.T., Fasting Blood
Sugar, Post Prandial Blood Sugar Renal Function
Test- Blood urea, Serum Creatinine, Liver
Function Test - Serum bilirubin (T), Serum
Glutamic Oxaloacetic Transaminase, Serum
Glutamic Pyruvic Transaminase, HIV, VDRL,
HBsAg, Urine analysis- Albumin, Sugar &
Microscopic was carried out. All above laboratory
investigations were carried out for fitness of the
patients for anesthesia and surgery. So these
investigations were done only before treatment.
HIV, VDRL, Australia antigen were done to
avoid the contamination of Operation Theatre
(OT) as well as the surgeon and paramedical
staff. Chest X-Ray, ECG, USG Abdomen & Pelvis
was done in cases of age above 40 years for fitness
of patient.
Procedure for preparation of Ksharsutra
Ksharsutra prepared by Apamarga Kshara
(Achyranthus aspera L.), Snuhi Ksheera (latex of
Euphorbia nerifolia L.), and Haridra Churna
(powder of Curcuma longa L.) and standard
method described in Ayurvedic Pharmacopia of
India was followed. [8]
Grouping
Patients registered for trial were randomly
divided in two groups i.e. A & B. In group-A,
patients were treated by standard Apamarga
Ksharsutra ligation with transfixation of sentinel
tag with maximum possible anal dilatation under
local anesthesia and in group-B, patients were
treated by Lateral Internal Sphincterotomy
followed by excision of sentinel tag under local
anesthesia. Post operative treatment such as
Panchwalkala kwatha for sitz bath, Jatyadi Taila
Matrabasti and 5 g Erandbhrishta Haritaki
churna (administered orally at bed time with luke
warm water) were given in both groups.
Operative procedure:
ļ‚· Common preoperative procedures
adopted for both Groups:
The written informed consent was taken
from every patient before the operation.
Patient was kept nil orally, at least 6 hours
before surgery. Preparation of parts i.e.
shaving of perineal area was done. Soap
water enema at 10 pm day before surgery
and proctolysis enema at 7 am on the day
of operation was given. Inj. Tetanus
Toxoid, 0.5 ml, intramuscular (IM) and
Intra-dermal injection of xylocaine 2%
sensitivity test was done before surgery.
ļ‚· Procedure of Ksharsutra transfixation in
Group-A:
The patient was laid down in the
lithotomy position followed by Painting
and draping of local part. Local anesthesia
was given by infiltration of Inj. Xylocaine
2% with adrenaline. Anal sphincters were
dilated with two fingers, forcefully in
lateral direction and anterior-posterior
portion of anal canal but in controlled
manner. The whole fissure bed including
IJPBA,
Nov-Dec,
2017,
Vol.
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Issue,
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Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of
Parikartika (Chronic Fissure-in-Ano)
Ā© 2010, IJPBA. All Rights Reserved 44
all fibrous tissue was incised by tissue
cutting scissor and fibers of internal anal
sphincter was separated with blunt
dissection by gauze piece from fissure bed
till anoderm, then sentinel tag was trans-
fixed by Ksharsutra with the help of
round body curved needle. After
hemostasis, sterilized dressing was carried
out and 'T'-bandage was applied.
ļ‚· Procedure of LIS (Lateral Internal
Sphincterotomy) in Group-B:
Local anesthesia was given by infiltration
of Inj. Xylocaine 2% with adrenaline.
Inter-sphincteric groove was palpated with
the index finger very well and blade (no.
15) was inserted through the perianal skin,
immediately lateral to the lower edge of the
internal sphincter and passed vertically
upwards in the inter sphincteric plane till
level of the pectinate line. By means of
delicate strokes of the blade in the direction
of the anal canal the lower half of the
internal sphincter was divided. The care
has been taken to prevent the lining of the
anal canalā€™s mucosa from penetration.
Pressure packing was done for 5 minutes to
reduce chances of hematoma. After that the
whole fissure bed including all fibrous
tissue and sentinel tag was excised with the
help of scissor. After haemostasis,
sterilized dressing was done and 'T'-
bandage was applied.
ļ‚· Post-operative regimens for both
groups:
Appropriate I.V. fluids, antibiotic and
analgesic were used as per requirement.
From next day onwards warm water along
with Panchwalkal kwatha sitz bath, two
times a day. Matra Basti with Jatyadi Tail
-10 ml, once daily after sitz bath.
Erandbhrishta Haritaki churna- 5 gm at
bed time with luke warm water was
administered daily. Post-operative
regimens were given for four weeks.
Duration of assessment: After the Ksharsutra
ligation or LIS, patients were assessed on weekly
interval up to 4 weeks. Follow up was taken one
month after completion of the treatment.
Assessment Criteria: Improvement in post
operative complains were assessed by specially
designed gradation method. Post operative
complains such as pain, swelling, oozing and
wound healing duration were evaluated.
Statistical Test: The Wilcoxan Signed rank test
was used to evaluate the effect of individual
treatment and the Mann Whitney Rank Sum test
was applied for inter group comparison as the data
were non parametric in nature.
OBSERVATIONS & RESULTS
Total 30 patients who fulfill the inclusion criteria
were registered and completed in trial. They are
randomly and equally allocated in both groups.
No patients dropped out from the trial.
In demographic data, Maximum numbers of
patients (43.33%) were found in age group
between 31 and 50 years. 53.33% patients were
male. 80% patients had urban back ground, Socio-
economically middle class patients were
maximum (60%). (Table no.1)
Table no.1- Demographic data of clinical trial
Demographi
c indicator
Characteri
stics
In group
A
In Group
B
Total. N,
(%)
Age group 17-30 year 7 4 11 (36.67)
31-50 year 6 7 13(43.33)
51-70 year 2 4 6 (20)
Participants Women 8 6 14 (46.67)
Man 7 9 16 (53.33)
Socio-
Economic
situation
Rich 1 0 1 (3.3)
Medium 9 9 18 (60)
Poor 5 6 11 (36.7)
Literacy Literate 11 12 23 (76.7)
Illiterate 4 3 7 (23.3)
Dwelling
status
Urban 12 12 24 (80)
Rural 3 3 6 (20)
Marital
status
Married 13 13 26 (86.7)
Unmarried 2 2 4 (13.3)
On local examination, all the patients of chronic
fissure in ano developed sentinel tag, healthy skin,
and no discharge. 66.67% patients had spasmodic
anal sphincter while 46.7% patients had papilla.
(Table no. 2)
Table no. 2- group wise distribution of findings of local
examination
Local
examinati
on
Characteristics In
group A
In Group
B
Total, n
(%)
Status of
perianal
skin
Healthy 15 15 30 (100)
Unhealthy 0 0 0
Discharg
e from
anal
canal
Present 0 0 0
Absent 15 15 30 (100)
Position
of fissure
in ano
Anterior 2 4 6 (20)
Posterior 9 7 16 (53.3)
Anterior and
posterior
4 4 8 (26.7)
Anal
sphincter
tone
Spasmodic 8 12 20 (66.7)
Normal 7 3 10 (33.3)
Anal
papilla
Present 7 7 14 (46.7)
Absent 8 8 16 (53.7)
In Ksharsutra treated group, Mean time required
to relieve post-operative pain was 10.66Ā±5.7 days,
IJPBA,
Nov-Dec,
2017,
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Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of
Parikartika (Chronic Fissure-in-Ano)
Ā© 2010, IJPBA. All Rights Reserved 45
while post operative swelling was relieved 100%
within 4.6Ā±1.6 days. Post operative oozing was
stopped by 3.75 Ā±1.5 days only and Mean time for
wound healing was found 24.60 Ā±5.9 days. (Table
no. 3)
In LIS treated group, Mean time for post-
operative pain was found 8 Ā±4.7 days, whereas
post operative swelling was relieved completely
within 3.25 Ā±1.2 days. Post operative oozing was
stopped by 2.7 Ā±1.1 days and Mean time for
wound healing was found 22.13 Ā±6.4 days. (Table
no. 3)
Table no. 3- Average days required to relieve the post
operative symptoms in both groups
post operative
symptoms
Group-A, MeanĀ±SD
(In days)
Group-B, MeanĀ±SD
(In days)
Pain P/R 10.66Ā±5.7 8 Ā±4.7
Swelling 4.625 Ā±1.6 3.25 Ā±1.2
Oozing of blood
P/R
3.75 Ā±1.5 2.7 Ā±1.1
Wound healing 24.60 Ā±5.9 22.13 Ā±6.4
In comparison between both groups, no statistical
difference was found in all the post operative
complaints. (Table no. 4)
Table no. 4- comparison of post operative complaints between
both the arms.
No of
days
required
for
Groups Medial 25% 75% ā€˜Pā€™
pain
relieving
Group-A (n=15) 7.00 6.000
14.00 0.221
(IS)
Group-B(n=15) 7.00 5.250 7.00
relief in
swelling
Group-A (n=8) 4.00 3.50
6.00 0.127
(IS)
Group-B (n=8) 3.50 2.00 4.00
stop
oozing
Group-A (n=8) 3.500 2.500
5.00
0.155
(IS)
Group-B(n=10) 2.500 2.000
4.00
operative
wound
healing
Group-A (n=15) 28 21 30
0.383
(IS)
Group-B(n=15) 21 15.75 30
n- no. of subjects, 25%- 1st quarter, 75%- last quarter
Mann-Whitney Rank Sum Test, P <0.05 - insignificant
difference,
In this study post operative complications like
perianal abscess, fistula-in-ano or incontinence
were not found in any group but Skin tag was
developed in two patients at operated site in
Ksharsutra treated group.
DISCUSSION
Presently fissure in ano is defined as an elongated
ulcer in the long axis of the anal canal (Bailey and
Love). [9]
Initiating factor in the development of a
fissure is trauma to the anal canal, usually in the
form of the passage of a fecal bolus that is large
and hard. [10]
Literatures strongly suggests that
LATERAL INTERNAL SPHINCTEROTOMY is
the operative treatment of choice for patients with
a chronic anal fissure[11]
as it do not required
hospitalization, it can be performed with the
patient under local anesthesia, Postoperative
discomfort is of short duration, and wounds heal
quickly. Fecal soiling is an infrequent problem,
and recurrence after this procedure is uncommon.
[12]
Present study shows that all the patients of both
treatment arms were completely cure which
indicates 100% relief of both the procedure and
there is no statistical difference on the post
operative complains between both the groups
However, mean time required to relieve all the
post operative complaints were found minimal in
LIS treated group in comparison to Ksharsutra
treated group which may indicate to better
efficacy and applicability of LIS as operative
procedure for the management of Parikartika
(Chronic fissure-in-ano). As sample size was
limited in present study, power of the study may
be low and thus statistical significant difference
was not obtained within the arms. Therefore it is
suggested to conduct clinical trial to analyze the
efficacy of Ksharsutra ligation on fissure-in-ano
(Parikartika) with good number of subject.
Mode of action of Ksharsutra
The Apamarga Kshara possesses Chhedana
(excision), Bhedana (incision), Ksharana
(debridation), Stambhana (haemostatic),
Shodhana (purification/sterilization), and Ropana
(healing) properties. ksharsutra ligated at fissure
bed excises the fibrotic tissue by action of
Ksharana and removes unhealthy fibrous tissue
and debris; makes the wound healthy by
Shodhana property.[13]
The Snuhi Ksheera is
slightly acidic in nature but also has antibacterial
property[14]
which helps to check secondary
infection. The Haridra has anti-inflammatory as
well as antibacterial [15]
properties and hence, it is
capable to make the wound clean, healthy, and
promote early healing.[16]
Ksharsutra may
produce gradual but sustained chemical action
which removes debris from the site of fissure bed
and also helps in formation of healthy granulation
tissue thereby inducing a long healing pattern in
depth of the tissue. Ksharsutra also breaks up the
fibrosed tissue and ultemately drains creating a
healthy base for healing.[17]
Probable mode of action of adjuvant drugs
The Panchavalkala Kwatha[18]
was used for
Avagaha Swedana (warm water sitz bath);[19]
has
Shodhana, Stambhana, Shothahara
IJPBA,
Nov-Dec,
2017,
Vol.
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Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of
Parikartika (Chronic Fissure-in-Ano)
Ā© 2010, IJPBA. All Rights Reserved 46
(antiinflammatory), and Vedanahara (analgesic)
properties, which helped to relieve pain, local
Shotha (edema) as well as to stop oozing and
maintained perianal hygiene. The ingredients of
Panchavalkala Kwatha (Vata, Ududmbara, Plux,
Parish, Ashwatha) are having predominant of
Kashaya Rasa. So when the Kwatha was used for
sitz bath, it exhibited Vrana Shodhana and Vrana
Ropana properties.[20]
Erandbhrita Haritaki churna is specially indicated
for Vibandha (constipation),[21]
Most of the ingredients used in Jatyadi Taila are
Shothahara, Vedanasthapana, and Ropana, which
are important requirements for healing of the
wound.[22]
Jatyadi Taila was instilled per rectal 10
ml after sitz bath to reduce the swelling and pain
as well as for smooth evacuation of feces. The
ingredients of the Taila like Neem (Azadirechta
indica A. Juss)[23, 24]
and Daruharidra (Beriberis
aristate DC.) are proven drugs to check bacterial
growth and promotes wound healing.
Hence, it is clear that, wound healing after cut
through of Ksharsutra from fissure bed was well
achieved by per rectal instillation of Jatyadi Tail,
Avagaha Swedana with Panchwalkala Kwatha
and orally Erandbrust Haritaki churna in both
groups.
CONCLUSION
In both, Ksharsutra treated and LIS treated
groups, all the patients were cured 100 percent but
mean time for relief in post operative complaints
like pain, swelling and oozing were found less in
LIS treated group (Lateral Internal
Sphincterotomy) than Ksharsutra ligation. Hence,
it can be concluded that the Lateral Internal
Sphincterotomy with excision of skin tag is more
effective treatment modality than Ksharsutra
ligation with maximum possible anal dilatation in
the management of Parikartika (chronic fissure in
ano).
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Ksharsutra vs LIS for Chronic Fissure

  • 1. *Corresponding Author: Dr. Manoj Bhadja, Email: bhadjamanoj@gmail.com ISSN 0976 ā€“ 3333 RESEARCH ARTICLE ICLE Available Online at www.ijpba.info International Journal of Pharmaceutical & Biological Archives 2017; 8(6): 42-47 A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) *Dr. Manoj Bhadja1 , Dr. T.S. Dudhamal2 1* Assistant Professor, Dept. of Shalya Tantra, IPGT&RA, Gujarat Ayurved University, Jamnagar, Gujarat. India 2 Associate Professor & I/c Head Dept. of Shalya Tantra, IPGT&RA, Gujarat Ayurved University, Jamnagar, Gujarat. India Received 30 Sep 2017; Revised 20 Oct 2017; Accepted 12 Nov 2017 ABSTRACT Background: Parikartika which resembles fissure-in-ano described as a complication of various diseases in Ayurvedic texts such as Vatika jwara, Vatika pakwa atisara, Sahaja arsha, Kaphaja arsha, Arsha purvarupa, Udavarta, complication of pregnancy (Garbhini), unlawful administration of purgative or enema (Basti), complication of Vamana and Virechana. As Ksharsutra , proven successful treatment modality for fistula-in-ano and piles to try its efficacy in chronic fissure-in-ano. Aim: To compare Apamarga Ksharsutra ligation and Lateral Internal Sphincterotomy (LIS) in the management of Parikartika (Chronic fissure-in-ano). Materials and Methods: Total 30 patients of Parikartika were selected and randomly divided in to two Groups (15 in each group). In group-A, Ksharsutra ligation with maximum possible anal dilatation was carried out while in group-B Lateral Internal Sphincterotomy with excision of skin tag was carried out under local anesthesia. Relief in symptoms and post operative complications in subjects were assessed for 4 weeks and follow up period was 1 month. Results: In both groups, significant results were found individually but difference was statistically insignificant. Duration required for relief in post- operative pain, bleeding, swelling and wound healing was found more in group-A (Ksharsutra) than group-B (LIS). Conclusion: Lateral Internal Sphincterotomy produced better results in compare to Ksharsutra ligation in the management of Parikartika (Chronic Fissure-in-Ano). Key words: Parikartika, Fissure-in-ano, Ksharsutra , Lateral Internal Sphincterotomy. INTRODUCTION In the Ayurvedic texts, Parikartika (cutting pain in Ano) is described as a symptom of various disease conditions such as Vatika jwara, Vatika pakwa atisara, Sahaja arsha, Kaphaj arsha, Arsha purvarupa, Udavarta, complication of pregnancy (Garbhini), unlawful administration of purgative or enema (Basti), complication of Vamana and Virechana. It was considered as disease first time in Kashyapasamhita and its types based on Dosha were also described. This classification was also followed in Sharangdharasamhita in medieval period. [1] Fissure in ano is an elongated ulcer in the long axis of the anal canal.[2] Etiology of fissure-in-ano is primarily constipation with passing of hard stool and secondary due to many diseases like chronic amoebic dysentery, diverticulitis, irritable bowel syndrome, ulcerative colitis etc. The common site of fissure-in-ano is 6 oā€™clock (midline posterior) in lower half of the anal canal which is commonly found in young adults and after delivery in females. The disease has been classified into two varieties viz., acute and chronic fissure-in-ano. Acute fissure-in-ano can be subsided by conservative treatment but in chronic cases surgical intervention is needed.[3] In modern surgical treatments such as Lordā€™s anal dilatation, fissurectomy, and sphincterotomy for anal fissure are suggested but they have their own limitations like recurrence, incontinence, etc. Ayurvedic para-surgical procedure, Ksharsutra ligation, is found successful treatment modality for anorectal disorders like fistula-in-ano [4] hemorrhoids, [5] and chronic fissure-in-ano [6] but with limited data. Presently, Lateral Internal Sphincterotomy (LIS) is considered as gold standard treatment for chronic fissure-in-ano.[7] There is a need to compare both treatment procedures i.e. Ksharsutra ligation and Lateral Internal Sphincterotomy. Considering all these factors, present study was planned with aim to
  • 2. Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) Ā© 2010, IJPBA. All Rights Reserved 43 compare Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic fissure-in-ano). MATERIALS AND METHODS: Selection of Patients: The patients of Parikartika (chronic fissure in ano) were selected from OPD/IPD of study centre irrespective of age, gender, occupation and religion. Clinical trial was approved by Institutional Ethics Committee (ref. no. PGT/7/- A/Ethics/2014-15/1538 dated 02.09.2014) and registered in CTRI (Reg. no. CTRI/2016/02/006679) retrospectively. Inclusion criteria: Patients of age group between 17-60 years of Parikartika (Chronic fissure-in-ano) having duration more than 6 months were included in the study. Exclusion Criteria: Patients of fissure-in-ano with less than 6 months duration, chronic fissure-in-ano associated with piles & fistula, malignancy of anorectum or any other organs were excluded. Positive cases for HIV, VDRL, Hepatitis-B and uncontrolled cases of Diabetes Mellitus and Hypertension were also excluded. Diagnostic Criteria: The patients were diagnosed on the basis of history, signs and symptoms, local examination with digital per rectal examination of and feature of chronic fissure in ano. Digital per rectal examination was carried out with 2% Xylocaine jelly to assess the sphincter tone after assessing the tolerance of pain and consent of patient. Proctoscopic examination was done after giving suitable anesthesia at the time of operation to exclude other anorectal pathologies like piles, polyp, any growth, etc. Laboratory Investigations: Routine Haemogram, B.T., C.T., Fasting Blood Sugar, Post Prandial Blood Sugar Renal Function Test- Blood urea, Serum Creatinine, Liver Function Test - Serum bilirubin (T), Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, HIV, VDRL, HBsAg, Urine analysis- Albumin, Sugar & Microscopic was carried out. All above laboratory investigations were carried out for fitness of the patients for anesthesia and surgery. So these investigations were done only before treatment. HIV, VDRL, Australia antigen were done to avoid the contamination of Operation Theatre (OT) as well as the surgeon and paramedical staff. Chest X-Ray, ECG, USG Abdomen & Pelvis was done in cases of age above 40 years for fitness of patient. Procedure for preparation of Ksharsutra Ksharsutra prepared by Apamarga Kshara (Achyranthus aspera L.), Snuhi Ksheera (latex of Euphorbia nerifolia L.), and Haridra Churna (powder of Curcuma longa L.) and standard method described in Ayurvedic Pharmacopia of India was followed. [8] Grouping Patients registered for trial were randomly divided in two groups i.e. A & B. In group-A, patients were treated by standard Apamarga Ksharsutra ligation with transfixation of sentinel tag with maximum possible anal dilatation under local anesthesia and in group-B, patients were treated by Lateral Internal Sphincterotomy followed by excision of sentinel tag under local anesthesia. Post operative treatment such as Panchwalkala kwatha for sitz bath, Jatyadi Taila Matrabasti and 5 g Erandbhrishta Haritaki churna (administered orally at bed time with luke warm water) were given in both groups. Operative procedure: ļ‚· Common preoperative procedures adopted for both Groups: The written informed consent was taken from every patient before the operation. Patient was kept nil orally, at least 6 hours before surgery. Preparation of parts i.e. shaving of perineal area was done. Soap water enema at 10 pm day before surgery and proctolysis enema at 7 am on the day of operation was given. Inj. Tetanus Toxoid, 0.5 ml, intramuscular (IM) and Intra-dermal injection of xylocaine 2% sensitivity test was done before surgery. ļ‚· Procedure of Ksharsutra transfixation in Group-A: The patient was laid down in the lithotomy position followed by Painting and draping of local part. Local anesthesia was given by infiltration of Inj. Xylocaine 2% with adrenaline. Anal sphincters were dilated with two fingers, forcefully in lateral direction and anterior-posterior portion of anal canal but in controlled manner. The whole fissure bed including IJPBA, Nov-Dec, 2017, Vol. 8, Issue, 6
  • 3. Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) Ā© 2010, IJPBA. All Rights Reserved 44 all fibrous tissue was incised by tissue cutting scissor and fibers of internal anal sphincter was separated with blunt dissection by gauze piece from fissure bed till anoderm, then sentinel tag was trans- fixed by Ksharsutra with the help of round body curved needle. After hemostasis, sterilized dressing was carried out and 'T'-bandage was applied. ļ‚· Procedure of LIS (Lateral Internal Sphincterotomy) in Group-B: Local anesthesia was given by infiltration of Inj. Xylocaine 2% with adrenaline. Inter-sphincteric groove was palpated with the index finger very well and blade (no. 15) was inserted through the perianal skin, immediately lateral to the lower edge of the internal sphincter and passed vertically upwards in the inter sphincteric plane till level of the pectinate line. By means of delicate strokes of the blade in the direction of the anal canal the lower half of the internal sphincter was divided. The care has been taken to prevent the lining of the anal canalā€™s mucosa from penetration. Pressure packing was done for 5 minutes to reduce chances of hematoma. After that the whole fissure bed including all fibrous tissue and sentinel tag was excised with the help of scissor. After haemostasis, sterilized dressing was done and 'T'- bandage was applied. ļ‚· Post-operative regimens for both groups: Appropriate I.V. fluids, antibiotic and analgesic were used as per requirement. From next day onwards warm water along with Panchwalkal kwatha sitz bath, two times a day. Matra Basti with Jatyadi Tail -10 ml, once daily after sitz bath. Erandbhrishta Haritaki churna- 5 gm at bed time with luke warm water was administered daily. Post-operative regimens were given for four weeks. Duration of assessment: After the Ksharsutra ligation or LIS, patients were assessed on weekly interval up to 4 weeks. Follow up was taken one month after completion of the treatment. Assessment Criteria: Improvement in post operative complains were assessed by specially designed gradation method. Post operative complains such as pain, swelling, oozing and wound healing duration were evaluated. Statistical Test: The Wilcoxan Signed rank test was used to evaluate the effect of individual treatment and the Mann Whitney Rank Sum test was applied for inter group comparison as the data were non parametric in nature. OBSERVATIONS & RESULTS Total 30 patients who fulfill the inclusion criteria were registered and completed in trial. They are randomly and equally allocated in both groups. No patients dropped out from the trial. In demographic data, Maximum numbers of patients (43.33%) were found in age group between 31 and 50 years. 53.33% patients were male. 80% patients had urban back ground, Socio- economically middle class patients were maximum (60%). (Table no.1) Table no.1- Demographic data of clinical trial Demographi c indicator Characteri stics In group A In Group B Total. N, (%) Age group 17-30 year 7 4 11 (36.67) 31-50 year 6 7 13(43.33) 51-70 year 2 4 6 (20) Participants Women 8 6 14 (46.67) Man 7 9 16 (53.33) Socio- Economic situation Rich 1 0 1 (3.3) Medium 9 9 18 (60) Poor 5 6 11 (36.7) Literacy Literate 11 12 23 (76.7) Illiterate 4 3 7 (23.3) Dwelling status Urban 12 12 24 (80) Rural 3 3 6 (20) Marital status Married 13 13 26 (86.7) Unmarried 2 2 4 (13.3) On local examination, all the patients of chronic fissure in ano developed sentinel tag, healthy skin, and no discharge. 66.67% patients had spasmodic anal sphincter while 46.7% patients had papilla. (Table no. 2) Table no. 2- group wise distribution of findings of local examination Local examinati on Characteristics In group A In Group B Total, n (%) Status of perianal skin Healthy 15 15 30 (100) Unhealthy 0 0 0 Discharg e from anal canal Present 0 0 0 Absent 15 15 30 (100) Position of fissure in ano Anterior 2 4 6 (20) Posterior 9 7 16 (53.3) Anterior and posterior 4 4 8 (26.7) Anal sphincter tone Spasmodic 8 12 20 (66.7) Normal 7 3 10 (33.3) Anal papilla Present 7 7 14 (46.7) Absent 8 8 16 (53.7) In Ksharsutra treated group, Mean time required to relieve post-operative pain was 10.66Ā±5.7 days, IJPBA, Nov-Dec, 2017, Vol. 8, Issue, 6
  • 4. Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) Ā© 2010, IJPBA. All Rights Reserved 45 while post operative swelling was relieved 100% within 4.6Ā±1.6 days. Post operative oozing was stopped by 3.75 Ā±1.5 days only and Mean time for wound healing was found 24.60 Ā±5.9 days. (Table no. 3) In LIS treated group, Mean time for post- operative pain was found 8 Ā±4.7 days, whereas post operative swelling was relieved completely within 3.25 Ā±1.2 days. Post operative oozing was stopped by 2.7 Ā±1.1 days and Mean time for wound healing was found 22.13 Ā±6.4 days. (Table no. 3) Table no. 3- Average days required to relieve the post operative symptoms in both groups post operative symptoms Group-A, MeanĀ±SD (In days) Group-B, MeanĀ±SD (In days) Pain P/R 10.66Ā±5.7 8 Ā±4.7 Swelling 4.625 Ā±1.6 3.25 Ā±1.2 Oozing of blood P/R 3.75 Ā±1.5 2.7 Ā±1.1 Wound healing 24.60 Ā±5.9 22.13 Ā±6.4 In comparison between both groups, no statistical difference was found in all the post operative complaints. (Table no. 4) Table no. 4- comparison of post operative complaints between both the arms. No of days required for Groups Medial 25% 75% ā€˜Pā€™ pain relieving Group-A (n=15) 7.00 6.000 14.00 0.221 (IS) Group-B(n=15) 7.00 5.250 7.00 relief in swelling Group-A (n=8) 4.00 3.50 6.00 0.127 (IS) Group-B (n=8) 3.50 2.00 4.00 stop oozing Group-A (n=8) 3.500 2.500 5.00 0.155 (IS) Group-B(n=10) 2.500 2.000 4.00 operative wound healing Group-A (n=15) 28 21 30 0.383 (IS) Group-B(n=15) 21 15.75 30 n- no. of subjects, 25%- 1st quarter, 75%- last quarter Mann-Whitney Rank Sum Test, P <0.05 - insignificant difference, In this study post operative complications like perianal abscess, fistula-in-ano or incontinence were not found in any group but Skin tag was developed in two patients at operated site in Ksharsutra treated group. DISCUSSION Presently fissure in ano is defined as an elongated ulcer in the long axis of the anal canal (Bailey and Love). [9] Initiating factor in the development of a fissure is trauma to the anal canal, usually in the form of the passage of a fecal bolus that is large and hard. [10] Literatures strongly suggests that LATERAL INTERNAL SPHINCTEROTOMY is the operative treatment of choice for patients with a chronic anal fissure[11] as it do not required hospitalization, it can be performed with the patient under local anesthesia, Postoperative discomfort is of short duration, and wounds heal quickly. Fecal soiling is an infrequent problem, and recurrence after this procedure is uncommon. [12] Present study shows that all the patients of both treatment arms were completely cure which indicates 100% relief of both the procedure and there is no statistical difference on the post operative complains between both the groups However, mean time required to relieve all the post operative complaints were found minimal in LIS treated group in comparison to Ksharsutra treated group which may indicate to better efficacy and applicability of LIS as operative procedure for the management of Parikartika (Chronic fissure-in-ano). As sample size was limited in present study, power of the study may be low and thus statistical significant difference was not obtained within the arms. Therefore it is suggested to conduct clinical trial to analyze the efficacy of Ksharsutra ligation on fissure-in-ano (Parikartika) with good number of subject. Mode of action of Ksharsutra The Apamarga Kshara possesses Chhedana (excision), Bhedana (incision), Ksharana (debridation), Stambhana (haemostatic), Shodhana (purification/sterilization), and Ropana (healing) properties. ksharsutra ligated at fissure bed excises the fibrotic tissue by action of Ksharana and removes unhealthy fibrous tissue and debris; makes the wound healthy by Shodhana property.[13] The Snuhi Ksheera is slightly acidic in nature but also has antibacterial property[14] which helps to check secondary infection. The Haridra has anti-inflammatory as well as antibacterial [15] properties and hence, it is capable to make the wound clean, healthy, and promote early healing.[16] Ksharsutra may produce gradual but sustained chemical action which removes debris from the site of fissure bed and also helps in formation of healthy granulation tissue thereby inducing a long healing pattern in depth of the tissue. Ksharsutra also breaks up the fibrosed tissue and ultemately drains creating a healthy base for healing.[17] Probable mode of action of adjuvant drugs The Panchavalkala Kwatha[18] was used for Avagaha Swedana (warm water sitz bath);[19] has Shodhana, Stambhana, Shothahara IJPBA, Nov-Dec, 2017, Vol. 8, Issue, 6
  • 5. Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) Ā© 2010, IJPBA. All Rights Reserved 46 (antiinflammatory), and Vedanahara (analgesic) properties, which helped to relieve pain, local Shotha (edema) as well as to stop oozing and maintained perianal hygiene. The ingredients of Panchavalkala Kwatha (Vata, Ududmbara, Plux, Parish, Ashwatha) are having predominant of Kashaya Rasa. So when the Kwatha was used for sitz bath, it exhibited Vrana Shodhana and Vrana Ropana properties.[20] Erandbhrita Haritaki churna is specially indicated for Vibandha (constipation),[21] Most of the ingredients used in Jatyadi Taila are Shothahara, Vedanasthapana, and Ropana, which are important requirements for healing of the wound.[22] Jatyadi Taila was instilled per rectal 10 ml after sitz bath to reduce the swelling and pain as well as for smooth evacuation of feces. The ingredients of the Taila like Neem (Azadirechta indica A. Juss)[23, 24] and Daruharidra (Beriberis aristate DC.) are proven drugs to check bacterial growth and promotes wound healing. Hence, it is clear that, wound healing after cut through of Ksharsutra from fissure bed was well achieved by per rectal instillation of Jatyadi Tail, Avagaha Swedana with Panchwalkala Kwatha and orally Erandbrust Haritaki churna in both groups. CONCLUSION In both, Ksharsutra treated and LIS treated groups, all the patients were cured 100 percent but mean time for relief in post operative complaints like pain, swelling and oozing were found less in LIS treated group (Lateral Internal Sphincterotomy) than Ksharsutra ligation. Hence, it can be concluded that the Lateral Internal Sphincterotomy with excision of skin tag is more effective treatment modality than Ksharsutra ligation with maximum possible anal dilatation in the management of Parikartika (chronic fissure in ano). REFERENCES 1. Sharma H,editor. Kashyapa Samhita of Kashyapa, Khilsthan. Reprint ed. Ch. 10, Ver.101. Varanasi: Chaukhamba Publication; 2009, 299. 2. Baily and loveā€Ÿs Short Practice of surgery, Hodder Arnold part of Hachette, UK, 24th edition 2004, 1252 3. Khan RM, Itrat M, Ansari AH, Ahmer SM, Zulkifle. Prevalence of Fissure-in- Ano among the Patients of Anorectal Complaints Visiting Nium Hospital. J Community Med Health Educ 2015; 5:344. 4. Panigrahi HK, Rani R, Padhi MM, Lavekar GS. Clinical Evaluation of Kshara sutra Therapy in the management of Bhagandara (Fistula- in-Ano)- A prospective study. Anc Sci Life. 2009; 28(3):29-35. 5. Gupta ML, Gupta SK, Bhuyan C. Comparative clinical evaluation of Kshara Sutra ligation and hemorrhoidectomy in Arsha (hemorrhoids). Ayu. 2011; 32(2): 225-9. 6. Dudhamal TS, Baghel MS, Bhuyan C, Gupta SK. Comparative study of Ksharsutra suturing and Lord's anal dilatation in the management of Parikartika (chronic fissure-in-ano). AYU 2014 35:141-7. 7. Philip. H. Gordon. Principles and Practise of Surgery for the Colon, Rectum and Anus, 3rd edition, New york, London, 2007.187 8. Anonymous. Ayurvedic Pharmacopia of India, 1st ed. Part-II. Vol-II. Dept. of AYUSH, Govt of India; New Delhi. 2001, 209ā€“13. 9. Baily and loveā€™s Short Practice of surgery, Hodder Arnold part of Hachette, UK, 24th edition 2004, 1252 10. Philip. H. Gordon. Principles and Practise of Surgery for the Colon, Rectum and Anus, New york, London; 3rd edition; 2007, 169 11. Philip. H. Gordon. Principles and Practise of Surgery for the Colon, Rectum and Anus, New york, London; 3rd edition; 2007, 187 12. Philip. H. Gordon. Principles and Practise of Surgery for the Colon, Rectum and Anus, New york, London; 3rd edition; 2007, 187 13. Sushruta, Sushruta Samhita, Sutra Sthana, Ksharapakavidhi Adhyaya, 11/5; edited by Shastri A, 12th ed. Chaukhambha Surabharti Sansthan, Varanasi, 2001,34. 14. Rasik AM, Shukla A, Patnaik GK, Dhawan BN, Kulshrestha BK, Srivastava S. Wound healing activity of the latex of Euphorbia nerifolia Linn. Indian J Pharmacol 1996;28:107-9. 15. Negi PS, Jayaprakasha GK, Jagan Mohan Rao L, Sakariah KK. Antibacterial activity of turmeric oil: A byproduct from IJPBA, Nov-Dec, 2017, Vol. 8, Issue, 6
  • 6. Bhadja manoj et al. A Comparative clinical study of Ksharsutra ligation and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-Ano) Ā© 2010, IJPBA. All Rights Reserved 47 curcumin manufacture. J Agric Food Chem 1999;47:4297-300. 16. Synopsis of turmericā€™s healing properties, Available from: http:// www.turmeric.co.in/turmeric_ayurvedic_u se.htm. [Last accessed on 2012 Jan 12]. 17. Hemantakumar panigrahi, Clinical evaluation of Ksharsutra therapy in the management of Bhagnadara (Fistula-in- ano) - a prospective study. Ancient science of life 2009; 28 (3): 29-35 18. Pandit Parsuram shastri, editor. Sharangdhar Samhita of Sharangdhar, Madhya khand, 6th edition. Ch.2, Ver. 149. Varanasi: Chaukhambha orientalia; 2005, 164. 19. Jensen SL. Treatment of first episodes of acute anal fissure: Prospective randomised study of lignocaine ointment versus hydrocortisone ointment or warm sitz baths plus bran. Br Med J (Clin Res Ed). 1986 3; 292:1167-9. 20. Misra B, editor. Bhavaprakasha nighantu of Bhavamishra, Ch. Vataadivarga. Ver-1 to 12. Varanasi: Chaukhambha Bharati Academy; 2006, 513- 18. 21. Tripathi Sri I, editor. Chakradatt of Chakrapani datta, 1st edition. Ch. 25, Ver. 11. Varanasi: Chaukhambha sanskrit sansthan; 1991, 243. 22. Dudhamal TS, Bhuyan C, Baghel MS. Wound healing effect of Jatyadi Taila in the cases of chronic fissure-in-ano treated with Ksharsutra. AYU International Research Journal of Ayurved 2013; 34 (5) (Suppl1);22 23. Dorababu M, Prabha T, Priyambada S, Agrawal VK, Aryya NC, Goel RK. Effect of Bacopa monniera and Azadirachta indica on gastric ulceration and healing in experimental NIDDM rats. Indian J Exp Biol 2004;42:389-97. 24. Biswas K, Chattopadhyay I, Banerjee RK, Bandyopadhyay U. Biological activities and medicinal properties of Neem (Azadirachta indica). Curr Sci 2002;82:1336-45. IJPBA, Nov-Dec, 2017, Vol. 8, Issue, 6