Ksharsutra for Fistula in Ano

Phase 3

Not yet recruiting

Conditions: 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,

Registration Number: CTRI/2023/10/058386

Lead Sponsor: Institute of Medical Sciences Banaras Hindu University

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. Sushrutaâ€™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 .

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RATE OF HEALING OF FISTULA	Baseline, 4 weeks, 8 weeks, 12 weeks. 16 weeks,20 weeks,24 weeks, 28 weeks, 32 weeks

Secondary Outcome Measures

Name	Time	Method
TIME TO HEAL	Baseline, 4 weeks, 8 weeks, 12 weeks. 16 weeks,20 weeks,24 weeks, 28 weeks, 32 weeks

Trial Locations

Locations (1): Faculty of Ayurveda,IMS,BHU
🇮🇳
Varanasi, UTTAR PRADESH, India
Faculty of Ayurveda,IMS,BHU
🇮🇳Varanasi, UTTAR PRADESH, India
Dr PRERNA VERMA
Principal investigator
8808588573
vermaprerna2012@gmail.com