Management of fistula in ano using Minimal invasive kshara sutra technique, LIFT & Conventional kshara sutra technique
Phase 3
- Conditions
- Health Condition 1: B998- Other infectious disease
- Registration Number
- CTRI/2023/06/053881
- Lead Sponsor
- ational institute of Ayurveda Amer Road Jaipur Rajasthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures <br/ ><br>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. <br/ ><br> <br/ ><br>2.Post-Operative complications (Early) <br/ ><br>â?¢Pain (Through Visual Analogue Scale ) <br/ ><br>â?¢Bleeding <br/ ><br>â?¢Itching <br/ ><br>â?¢Pus Discharge <br/ ><br>3.Post-Operative complications (Late) <br/ ><br>â?¢Incontinence (Through Wexner score) <br/ ><br>â?¢Stenosis (Through PASS) <br/ ><br>â?¢Recurrence <br/ ><br>Timepoint: 12 MONTHS
- Secondary Outcome Measures
Name Time Method â?¢Hospital stay. <br/ ><br>â?¢Time to return to work. <br/ ><br>â?¢Patient satisfaction (Quality of life assessment- SF-36) <br/ ><br>Timepoint: 18 months