FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (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.)
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (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 .

 
Close