Randomised controlled trial comparing cutting seton vs ligation of intersphincteric fistula tract (LIFT) for complex anal fistula

Not Applicable

Recruiting

• Conditions: Anal fistulae; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001258448
• Lead Sponsor: St George Hospital Colorectal research fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Adult patients aged 18-80 years with complex anal fistula. Complex fistulae are defined as high trans-sphincteric or supra-sphincteric fistulae, anteriorly situated fistulae in women, fistula disease in the presence of impaired continence, and any recurrent fistula.
Current loose seton in situ for drainage of sepsis
Able to give valid consent
Deemed suitable for either LIFT or cutting seton procedure by treating surgeon

Exclusion Criteria

Current active inflammatory bowel disease or known history of inflammatory bowel disease.
Fistulae not of cryptoglandular aetiology (e.g. radiation, foreign body, iatrogenic)
Multiple medical co-morbidities
Deemed unsuitable by the treating surgeon for either cutting seton or LIFT procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified