Randomised controlled trial comparing ligation of the intersphicteric fistula tract vs advancement flap for complex anorectal fistulas requiring intial seton drainage
Active, not recruiting
- Conditions
- Complex anorectal fistulas where setons were previously inserted because fistulotomy was deemed to risk significant incontinenceOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12611000522910
- Lead Sponsor
- Yik Hong Ho
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Patients with transsphincteric or complex fistulas were entered into the study. Fistulas were classified as complex if any of the following were present: tract crossing more than 30% to 50% of the external sphincter, anterior fistula in a woman, multiple tracts, recurrent fistula, pre-existing incontinence or Crohns disease.
Exclusion Criteria
Patients with Crohns disease were excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if ligation of the intersphicteric fistula tract provides at least a 40% improvement in recurrence rate over anorectal advancement flap for complex anorectal fistulas after initial seton drainage. This outcome will be assessed by clinical examination, history and if required MRI and ultrasound.[Patients were reviewed in clinics at weeks 2, 4 and 16 then annually thereafter.]
- Secondary Outcome Measures
Name Time Method Complications[At each clinical and history interview: at weeks 2, 4 and 16 then annually thereafter];Pain[At 1 month post operatively by an independent research nurse using a visual analogue scale (1-10)];Satisfaction[At 1 month post operatively by an independent research nurse using visual analogue scale (1-10)];Bowel function: return to normal healthy bowel function[At two weeks postoperatively by interview];Time taken to resume normal activities[One month postoperatively by interview];Incontinence[Pre and one month post operatively by an independent research nurse using using the Cleveland Clinic Florida Fecal Incontinence Score(0-20, 0=continent)]