Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

Not Applicable

Withdrawn

• Conditions: Anorectal Fistula
• Interventions: Procedure: LIFT

• Registration Number: NCT01913249
• Lead Sponsor: Sykehuset Innlandet HF

Brief Summary

The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Status Verified: 2013-09
• Study Start: 2013-09
• Primary Completion: 2018-04
• Study Completion: 2018-04-17
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 20 and 65 years

• Complex anal fistula defined as

  • anterior fistulas in women
  • branched fistulas
  • fistulas in patients with anal incontinence
  • fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.

Exclusion Criteria

• Crohn's disease in the rectum
• Previous LIFT surgery on same side
• Patient already treated with seton > 3 weeks
• Not able or willing to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	LIFT	Seton through fistula 3 weeks prior to LIFT surgery
Intervention	LIFT	Seton through fistula 6 months prior to LIFT

Primary Outcome Measures

Name	Time	Method
Complication	1 year	Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
Recurrence rate	1 year	Recurrence or non-healing of anal fistula one year after LIFT surgery

Trial Locations

Locations (1)

Sykehuset Innlandet; 🇳🇴 Hamar, Norway