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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Sykehuset Innlandet HF
Sponsor:
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT01913249
First received: July 29, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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: June 2015 (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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Ingrid Ylva Sahlin, PhD 0047 06200 Ylva.Sahlin@sykehuset-innlandet.no

Locations
Norway
Sykehuset Innlandet Recruiting
Hamar, Norway
Contact: Folstad       torbjornfolstad@gmail.com   
Sponsors and Collaborators
Sykehuset Innlandet HF
  More Information

No publications provided

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: September 6, 2013
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
LIFT
Seton

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

ClinicalTrials.gov processed this record on September 18, 2014