Management of fistula in ano using Minimal invasive kshara sutra technique, LIFT & Conventional kshara sutra technique

A Randomized Controlled Trial to assess the clinical and functional outcomes in patients of bhagandar (Transsphincteric anal fistula) using MIKST (Minimal invasive kshara sutra technique), LIFT (ligation of intersphincteric fistulous tract) and standard apamarg kshara sutra therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053881

Enrollment

Registered

2023-06-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B998- Other infectious disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient clinically diagnose as a case of Transsphincteric Anal fistula in the age group of 18 years to 70 years of either sex. 2. Patient willing to participate in the study. 3. Patients with classical sign symptoms of Bhagandara (Pidika, Daha, Puya Srava)

Exclusion criteria

Exclusion criteria: 1. Patients with other systemic illnesses like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis. 2. Infective and Neoplastic conditions of rectum, Rectal prolapse, Crohnâ??s disease. 3. Cases unfit and refused for surgery. 4. Patients having fistula in ano other than Transsphincteric type.

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures 1.Clinical healing of fistula in ano (No fistula opening & no fistula related symptoms on clinical examination & fistuloscopy) considering duration of complete healing in each arm. 2.Post-Operative complications (Early) â?¢Pain (Through Visual Analogue Scale ) â?¢Bleeding â?¢Itching â?¢Pus Discharge 3.Post-Operative complications (Late) â?¢Incontinence (Through Wexner score) â?¢Stenosis (Through PASS) â?¢Recurrence Timepoint: 12 MONTHS	—

Measure

Time frame

Primary Outcome Measures 1.Clinical healing of fistula in ano (No fistula opening & no fistula related symptoms on clinical examination & fistuloscopy) considering duration of complete healing in each arm. 2.Post-Operative complications (Early) â?¢Pain (Through Visual Analogue Scale ) â?¢Bleeding â?¢Itching â?¢Pus Discharge 3.Post-Operative complications (Late) â?¢Incontinence (Through Wexner score) â?¢Stenosis (Through PASS) â?¢Recurrence Timepoint: 12 MONTHS

—

Secondary

Measure	Time frame
â?¢ Hospital stay. â?¢ Time to return to work. â?¢ Patient satisfaction (Quality of life assessment- SF-36) Timepoint: 18 months	—

Countries

India

Contacts

Public ContactProf P Hemantha Kumar

National institute of Ayurveda, Amer Road, Jaipur, Rajasthan

profphknia@gmail.com9414056362

Outcome results