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Comparison between VAAFT vs Ksharsutra

To Assess the Efficacy of Video-Assisted Anal Fistula Treatment Versus Ksharsutra Insertion in the Management of Low Anal Fistula: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075577
Enrollment
70
Registered
2024-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: K603- Anal fistula

Interventions

Intervention1: VAAFT: Video-assisted anal fistula treatment is performed with a kit which includes a fistuloscope manufactured by Karl Storz GmbH (Tuttlingen, Germany), an obturator, a unipolar electr

Sponsors

All India Institute Of Medical Sciences, New Delhi
Lead Sponsor

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 evaluation and confirmed by MRI

Exclusion criteria

Exclusion criteria: 1. Severely immunocompromised or compromised cardio pulmonary status 2. Participants with uncontrolled comorbidities such as diabetes mellitus and hypertension 3. HIV/hepatitis B/VDRL positive 4. Colorectal carcinoma 5. Ulcerative colitis & Crohn’s patients 6. On anti-tubercular therapy 7. Prior history of anal incontinence 8. High anal fistula 9. Osteomyelitis

Design outcomes

Primary

MeasureTime frame
To evaluate the healing of low anal fistula in Video- Assisted Anal Fistula Treatment versus ksharsutra insertion at 3 months and 6 months after the intervention. Timepoint: 3 months and 6 months

Secondary

MeasureTime frame
To assess Recurrence at follow up To assess Pain on Visual analogue scale Quality of life (FIQLI)Timepoint: 3 months and 6 months

Countries

India

Contacts

Public ContactDr Nelson T

AIIMS, New Delhi

nelson.mbbs@gmail.com9789589298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026