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

This study has suspended participant recruitment.
(Unable to get MRI of patients within reasonable time on a local hospital.)
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
First received: July 29, 2013
Last updated: April 18, 2016
Last verified: September 2013
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.

Condition Intervention
Anorectal Fistula
Procedure: LIFT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Recurrence or non-healing of anal fistula one year after LIFT surgery

  • Complication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Seton through fistula 6 months prior to LIFT
Procedure: LIFT
Ligation of intersphincteric fistula tract
Active Comparator: Control
Seton through fistula 3 weeks prior to LIFT surgery
Procedure: LIFT
Ligation of intersphincteric fistula tract


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01913249

Sykehuset Innlandet
Hamar, Norway
Sponsors and Collaborators
Sykehuset Innlandet HF
  More Information

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT01913249     History of Changes
Other Study ID Numbers: 2013/581(REK) 
Study First Received: July 29, 2013
Last Updated: April 18, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Sykehuset Innlandet HF:
Anorectal fistula

Additional relevant MeSH terms:
Rectal Fistula
Digestive System Diseases
Digestive System Fistula
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Fistula
Pathological Conditions, Anatomical
Rectal Diseases

ClinicalTrials.gov processed this record on April 27, 2016