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

N/AWithdrawnNCT01913249

Sykehuset Innlandet HF

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Anorectal Fistula

Interventions

LIFTPROCEDURE

Ligation of intersphincteric fistula tract

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sykehuset Innlandet

Hamar, Norway

Outcomes

Primary Outcomes

Recurrence rate

Recurrence or non-healing of anal fistula one year after LIFT surgery

Time frame: 1 year

Complication

Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.

Time frame: 1 year

Data from ClinicalTrials.gov

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