CTRI Number |
CTRI/2025/06/088135 [Registered on: 03/06/2025] Trial Registered Prospectively |
Last Modified On: |
03/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare Ksharsutra treatment and surgical procedures for peri anal fistula |
Scientific Title of Study
|
A Randomized Controlled Clinical Trial on The Effect Of “Ksharsutra treatment†(Ayurvedic Medical Seton) Vs Conventional Surgical Treatment in Clinical Outcomes of Patients with Fistula-In-Ano |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Professor Virinder Kumar Bansal |
Designation |
Professor |
Affiliation |
AIIMS, New Delhi |
Address |
Room no-405 4th Floor Surgery Block AIIMS New Delhi
Pin-110049
South West DELHI 110049 India |
Phone |
9810348479 |
Fax |
|
Email |
drvkbansal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Professor Virinder Kumar Bansal |
Designation |
Professor |
Affiliation |
AIIMS, New Delhi |
Address |
Room no-405 4th Floor Surgery Block AIIMS New Delhi
Pin-110049
South West DELHI 110049 India |
Phone |
9810348479 |
Fax |
|
Email |
drvkbansal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ansin Sreeraj S |
Designation |
PG Surgery Junior Resident |
Affiliation |
AIIMS, New Delhi |
Address |
Room no-405 4th Floor Surgery Block AIIMS New Delhi
Pin-110049
South West DELHI 110049 India |
Phone |
6261446520 |
Fax |
|
Email |
ansinsreeraj1697@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Professor. Virinder Kumar Bansal |
Address |
Room no- 405 4th floor Surgery Block AIIMS New delhi Pin- 11004 |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Virinder Kumar Bansal |
AIIMS,New Delhi |
Room no- 405 4th floor
Surgery block AIIMS
New Delhi Pin-110049 South West DELHI |
9810348479
drvkbansal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute of ethics committee AIIMS of block Ansari Nagar New Delhi 29 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: K603||Anal fistula, (2) ICD-10 Condition: K605||Anorectal fistula, (3) ICD-10 Condition: K604||Rectal fistula, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Conventional Surgery for fistula-in-ano, fistulotomy or fistulectomy |
1.Fistulotomy
The first step is identification of primary fistula tract using malleable probe. After passing probe from external opening through internal opening, diathermy is used to divide the perianal skin and anal epithelium. If few fibres of striated muscle of internal sphincter is involved, that may be divided. If substatntial amount of fibres are involved, division of muscle is not advisable and seton is inserted. If high blind tract is identified, it should be adequately curetted and drained. Any bleeding from the edges should be secured by cautery and gauze dressing applied.
2.Fistulectomy
Similar to the fistulotomy, probe is inserted from external opening to internal opening and fistulous tract will excised using fine scalpel and cautery. All the tracts must be excised and cored out in complex fistula or multiple tracts. The defect in external sphincter may require closure and internal opening is closed with an anorectal advancement flaps.
|
Intervention |
Ksharsutra insertion for fistula-in-ano |
After piercing the internal opening, the tip of the probe comes out through the anal canal. Ksharsutra is fixed through the ends of the metal probe and the two free ends of Ksharsutra are tied. Gauze pad dressing will be done and subsequently the thread will be changed once per week. Depending on the cutting and healing of the tract the duration can vary from patients to patients. The process is repeated until the thread cuts open the tract. The total time taken for complete healing of the fistula tract from start of treatment will be noted. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Participants having low anal fistula (subcutaneous, submucosal, inter sphincteric fistula & trans sphincteric with less than 30% involvement of external sphincter) with single tract or multiple small tracts within 2-3 cm of each other and within 5 cm of anal verge diagnosed during clinical examination. |
|
ExclusionCriteria |
Details |
1.Age < 20 years or >70 years
2.Severely immunocompromised or compromised cardio pulmonary status
3.Participants with uncontrolled comorbidities such as diabetes mellitus and hypertension
4.HIV/hepatitis B/VDRL positive
5.Colorectal carcinoma
6.Ulcerative colitis & Crohn’s patients
7.On anti-tubercular therapy
8.Fistulas other than ano-rectal like recto vaginal fistula etc.
9.Anterior fistula-in-ano in women & pregnant women
10.Osteomyelitis
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the efficacy of Guggulu-based Ksharsutra treatment vs. conventional surgical treatment in primary healing of fistula-in-ano |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the recurrence rates of anal fistula between the Guggulu-based Ksharsutra treatment & conventional surgical treatment during follow-up |
3 months |
To evaluate the impact of both interventions on perianal symptoms including itching, discharge, burning sensation, pain, & anal incontinence at follow up |
3 months |
To assess the unit cutting time & healing time associated with the Ksharsutra intervention |
3 months |
To compare the duration of hospital stay & number of hospital visits required in both treatment groups. |
3 months |
To evaluate the cost-effectiveness of Guggulu-based Ksharsutra treatment compared to surgical management. |
3 months |
To assess the number of workdays lost due to the disease & its treatment in both groups |
3 months |
To evaluate & compare the quality of life post-treatment using standardized tools such as the Gastrointestinal Quality of Life Index (GIQLI) & Fecal Incontinence Quality of Life Scale (FIQOL) |
3 months |
|
Target Sample Size
|
Total Sample Size="384" Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
16/06/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
16/06/2025 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
1.Fistula-in-ano is one
of the most common inflammatory anorectal diseases affecting the perianal
region including the sphincter muscles, ischioanal fossae, and the perianal skin
2. Ksharsutra is a
widely accepted parasurgical treatment
3.This
procedure has multitude of advantages over conventional surgical therapy; like
it is an ambulatory procedure throughout the course of intervention and doesn’t
require extensive hospital stays which is cumbersome to the patient and the
treatment cost per patient is comparatively less . Ksharsutra has a better
post procedural scarring, quality of life and less recurrence compared to the
conventional surgery.It is observed that while performing Ksharsutra techniques
sphincteric tone can be preserved leading to minimal incontinence in patients.
Besides, Ksharsutra offers a relatively less invasive method for tackling
fistula-in-ano as compared to surgery, which can have recurrence rates of
20%-40%, while exposing the patient to risk of anesthetic complications as well
as prolonged hospital stay.
4.The Indian Council of
Medical Research has validated [15] this therapy by conducting multicentric
research trial and concluded that Ksharsutra is better than conventional
surgery in fistula‑in‑ano.
5.over the years
advancement in the field of Ayurvedic pharmaceutics has led to value addition
& pharmaceutical modification in Ksharsutra. There has been a number of
researches on the variants of classical Ksharsutra like nimba, aragwadha,
udumbara Ksharsutra.One such modified
form of classical Ksharsutra known as Guggulu Ksharsutra is also researched
6. This research study is proposed to
compare the effect of Guggulu based Ksharasutra in Fistula-in-ano vs. conventional surgical treatment modalities to understand its effect in healing,
recurrence and other morbidities associated with fistula-in-ano. This study
also proposes to evaluate and put forward the findings to clinical practice.
The treatment modalities will also be compared for the purpose of complete healing
of fistulous tract while preserving sphincter complex and improving quality of
life in these patients.
|