CTRI Number |
CTRI/2023/10/058386 [Registered on: 06/10/2023] Trial Registered Prospectively |
Last Modified On: |
04/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ksharsutra for Fistula in Ano |
Scientific Title of Study
|
A Comparative Analysis of The Interception of Fistulous Tract With the Application of Ksharsutra And Interception of Fistulous Tract With The Application of Surgical Linen Thread in The Management of Complex 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 |
Prerna Verma |
Designation |
Phd Scholar |
Affiliation |
Department of Shalya Tantra,Faculty of Ayurveda,IMS,BHU |
Address |
Department of Shalya Tantra,Faculty of Ayurveda,IMS,BHU
Varanasi UTTAR PRADESH 221005 India |
Phone |
8808588573 |
Fax |
|
Email |
vermaprerna2012@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrSJGupta |
Designation |
Professor |
Affiliation |
Banaras Hindu University |
Address |
Department of Shalya Tantra,Faculty of Ayurveda,IMS,BHU
Varanasi UTTAR PRADESH 221005 India |
Phone |
9415227419 |
Fax |
|
Email |
sjguptabhu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrSJGupta |
Designation |
Professor |
Affiliation |
Banaras Hindu University |
Address |
Department of Shalya Tantra,Faculty of Ayurveda,IMS,BHU
Varanasi UTTAR PRADESH 221005 India |
Phone |
9415227419 |
Fax |
|
Email |
sjguptabhu@gmail.com |
|
Source of Monetary or Material Support
|
Department of Shalya tantra
Faculty of Ayurveda IMS BHU |
|
Primary Sponsor
|
Name |
Institute of Medical Sciences Banaras Hindu University |
Address |
Faculty of Ayurveda,IMS BHU
VARANASI |
Type of Sponsor |
Government medical college |
|
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 PRERNA VERMA |
Faculty of Ayurveda,IMS,BHU |
Department of Shalya Tantra,Banaras Hindu University
IMS,BHU Varanasi UTTAR PRADESH |
8808588573
vermaprerna2012@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee,IMS,BHU |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: FISTULA IN ANO, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: , Procedure details: According to internal opening,an anterior or posterior window will be created 1 to 2 cm away from anal verge and interception of fistulous tract will be done ,with the application of Ksharsutra in proximal tract from window to internal opening, then ksharsutra will be change weekly upto complete healing.)
| 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: , Procedure details: According to internal opening,an anterior or posterior window will be created 1 to 2 cm away from anal verge & interception of fistulous tract will be done ,with the application of plain surgical linen thread in proximal tract from window to internal opening, then thread will be change weekly upto complete healing.)
|
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Age between 18 to 70 yrs.
2.Fistulas which are anatomically higher in extension (such as high intersphincteric , high trans-sphincteric or suprasphincteric fistulas).
3.Involve significant portions of the sphincter musculature (>50%).
4.Fistulas with multiple tracts or distant cutaneous extensions.
5.High horseshoe component
6.Recurrent fistulas
|
|
ExclusionCriteria |
Details |
Exclusion Criteria:
1.Low anal fistula in ano.
2.Non cryptoglandular fistula in ano.
3.Extrasphincteric fistulas.
4.Patients suffering with following ailments shall not be taken for the study:
a) Uncontrolled Hypertension
b) Coronary Artery Disease
c) Severe Anaemia
d) Carcinoma
e) HIV, HBsAg , Anti HCV
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
RATE OF HEALING OF FISTULA |
Baseline, 4 weeks, 8 weeks, 12 weeks. 16 weeks,20 weeks,24 weeks, 28 weeks, 32 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
TIME TO HEAL |
Baseline, 4 weeks, 8 weeks, 12 weeks. 16 weeks,20 weeks,24 weeks, 28 weeks, 32 weeks |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 3 |
Date of First Enrollment (India)
|
16/10/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Fistula-in-ano is the commonest anorectal disease which has chronic granulating tract running from the anal canal or rectum to the perianal skin or perineum and is associated with considerable discomfort and morbidity to the patient. Anorectal fistulas have been the subject of medical and lay literature for over 2,500 years. The term fistula is ascribed to John Arderne (1307-1392) whose classic work on anal fistula is still in print. However, it is important to note that in Ayurveda, Sushruta(1000BC-800BC) described both fistulotomy and fistulectomy as well as the chemical seton using Kshar Sutra (Sankaran PS. Sushruta’s contribution to surgery. Varanasi :1976). Parks et al. classified fistula in ano, which takes into account pathogenesis and the course of anal fistula. It emphasized specially upon the relationship of fistulous track to the external sphincter and is still used in practice to describe the fistula: inter-sphincteric (most commonly noted,75%), trans-sphincteric, supra-sphincteric, or extra-sphincteric1. The aim of surgery for anal fistula is to cure the patient with minimal or no sequela. During the last century, number of surgical procedures have been developed to minimize the recurrence and to prevent damage to the anal sphincter muscles in high anal fistulas. Fistulotomy, Fistulectomy, Cutting setons, loose setons, endorectal advancement flaps and dermal advancement flaps, have all been used as an alternative to fistulotomy with variable success rates. Each of these procedures carries significant risk of pain, healing complications and incontinence. This has led surgeons to switch to alternative methods of treatment like fibrin glue, anal fistula plug which do not carry any risk of sphincter function impairment and allow the patients an early return to activities. However, despite the development of these new techniques, management of fistula in ano is still a complex problem. The aim of fistula surgery is to eliminate the fistula, prevent recurrence, and preserve sphincter function. Success is usually determined by identification of the primary opening and dividing the least amount of muscle possible. Several methods have been proposed time to time for the better management of fistula in ano with variable recurrence rates and incontinence rates. Thus, successful treatment of complex fistula in ano still poses a big challenge to the surgical community. However, IFTAK can provide an answer to these. It is a novel, minimal invasive technique where the main emphasis is laid upon the accurate identification and eradication of the primary site of infection i.e., the infected anal crypt by the application of ksharsutra. Simultaneously, the primary track or its branches are allowed to heal by cutting them off from the primary source of infection at the site of interception. Even multiple tracts or branches can be dealt effectively through a single, small, cosmetic incision without the need of laying open or curetting them. Successful management of fistula in ano mainly depends upon the correct identification of the site of cryptoglandular infection and its prompt eradication rather than dealing with the tract or the branches and this is the main principle behind the IFTAK therapy. Complex fistulas are where the fistulous tract crosses >30% to 50% of the external sphincter or having multiple tracts or recurrent fistula2. Involvement of the anal sphincter during treatment of complex fistula poses a high risk for impairment of continence.3 Although fistula in ano seems to be a simple disease, inadequate surgical measures can cause significant morbidity. So, it is of utmost importance that as much information be available about the disease in a patient as possible prior to any surgical procedure, else recurrence is inevitable. So, cases of fistula in ano operated by this technique may yield good encouraging results. Till date, no any well-established data is available to establish the efficacy of IFTAK technique in complex Fistula in ano. So, in this proposed research work, it will try to establish the efficacy of IFTAK technique in complex Fistula in ano and analysing the relevance of ksharsutra in the management of complex Fistula in ano using interception of fistulous tract approach, whether the same effect can be obtained if a surgical linen thread is used in place of ksharsutra through IFTAK approach ? . As well as comparison of diagnostic accuracy among MRI and DRE with reference to findings revealed at the time of surgery . |