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

Sykehuset Innlandet HF

Status: Withdrawn

Conditions: Anorectal Fistula

Treatments: Procedure: LIFT

Study type: Interventional

Funder types: Other

Identifiers

NCT01913249

2013/581(REK)

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

Seton through fistula 6 months prior to LIFT

Treatment:

Procedure: LIFT

Control

Active Comparator group

Description:

Seton through fistula 3 weeks prior to LIFT surgery

Treatment:

Procedure: LIFT