Health Condition 1: - Health Condition 2: K603- Anal fistula Health Condition 3: K605- Anorectal fistula Health Condition 4: K604- Rectal fistula
Conditions
Interventions
Intervention1: 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 pr
Sponsors
Professor. Virinder Kumar Bansal
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1.Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Guggulu-based Ksharsutra treatment vs. conventional surgical treatment in primary healing of fistula-in-anoTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the recurrence rates of anal fistula between the Guggulu-based Ksharsutra treatment & conventional surgical treatment during follow-upTimepoint: 3 months;To evaluate the impact of both interventions on perianal symptoms including itching, discharge, burning sensation, pain, & anal incontinence at follow upTimepoint: 3 months;To assess the unit cutting time & healing time associated with the Ksharsutra interventionTimepoint: 3 months;To compare the duration of hospital stay & number of hospital visits required in both treatment groups.Timepoint: 3 months;To evaluate the cost-effectiveness of Guggulu-based Ksharsutra treatment compared to surgical management.Timepoint: 3 months;To assess the number of workdays lost due to the disease & its treatment in both groupsTimepoint: 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)Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Ansin Sreeraj S
AIIMS, New Delhi
Outcome results
None listed