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

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ClinicalTrials.gov Identifier: NCT01913249
Recruitment Status : Withdrawn (Unable to get MRI of patients within reasonable time on a local hospital.)
First Posted : August 1, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anorectal Fistula Procedure: LIFT Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 1 year ]
    Recurrence or non-healing of anal fistula one year after LIFT surgery

  2. Complication [ Time Frame: 1 year ]
    Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913249


Locations
Norway
Sykehuset Innlandet
Hamar, Norway
Sponsors and Collaborators
Sykehuset Innlandet HF

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT01913249     History of Changes
Other Study ID Numbers: 2013/581(REK)
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: September 2013

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