Comparing healing outcomes for cutting seton and the ligation of intersphincteric tract (LIFT) procedure in adult patients with complex primary fistula-in-ano

Not Applicable

Conditions: fistula-in-ano
Surgery - Surgical techniques
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12624000557538

Lead Sponsor: St George Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

•Adult patients (18 years and over) with complex cryptoglandular anal fistula requiring operative management
•Complex fistulae are defined as high trans- sphincteric or supra-sphincteric fistulas, anteriorly situated fistulas in women, fistula disease in the presence of impaired continence, and any recurrent fistulas
•Able to give valid consent
•Current loose seton in situ for control of perianal sepsis
•Deemed by treating surgeon based on imaging (endoanal ultrasound or MR) or examination under anaesthesia to be suitable for LIFT or cutting seton (based on anatomy of the tract)

Exclusion Criteria

•Fistula anatomy or patient deemed unsuitable by the treating surgeon for either cutting seton or LIFT
•Inflammatory bowel disease – currently active or known history
•Secondary/non-cryptoglandular aetiology (ie. radiation, trauma, malignancy)
•Active immunosuppression (diabetes excepted)
•Patients defunctioned with a stoma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of healing[Clinical assessment for persistent wound and discharge at 6 months 6 weeks, 12 weeks post primary/initial intervention<br>6 months following documented healing<br>6 months after primary healing is achieved is the primary end point]

Secondary Outcome Measures

Name	Time	Method
Faecal incontinence[St Mark's Vaizey incontinence score 6 weeks post initial intervention and 6 months following documented healing];Safety[Return to theatre, re-admissions, patient pain scores at 6 week review as a composite of safety outcome<br>Based on review of chart or communication from local treating team<br>Pain scores will be recorded via visual analogue scale Immediate post-operative complications (within 24 hours) and within the first 6 weeks post initial intervention (primary surgery)];Patient Satisfaction[Yes / No global satisfaction question<br>Surgical Satisfaction Questionaire 6 weeks following initial intervention and 6 months post healing global question<br>Surgical Satisfaction Questionaire for 6 weeks following initial intervention and 6mths post healing];Pain[Visual analogue pain scale At 6 weeks post initial intervention and 6months post healing]