Back to resultsEffect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula
Primary Purpose
Anorectal Fistula
Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
LIFT
Sponsored by
About this trial
This is an interventional treatment trial for Anorectal Fistula focused on measuring Anorectal fistula, LIFT, Seton
Eligibility 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
Sites / Locations
- Sykehuset Innlandet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Seton through fistula 6 months prior to LIFT
Seton through fistula 3 weeks prior to LIFT surgery
Outcomes
Primary Outcome Measures
Recurrence rate
Recurrence or non-healing of anal fistula one year after LIFT surgery
Complication
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01913249
Brief Title
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to get MRI of patients within reasonable time on a local hospital.
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorectal Fistula
Keywords
Anorectal fistula, LIFT, Seton
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Seton through fistula 6 months prior to LIFT
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Seton through fistula 3 weeks prior to LIFT surgery
Intervention Type
Procedure
Intervention Name(s)
LIFT
Intervention Description
Ligation of intersphincteric fistula tract
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence or non-healing of anal fistula one year after LIFT surgery
Time Frame
1 year
Title
Complication
Description
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sykehuset Innlandet
City
Hamar
Country
Norway
12. IPD Sharing Statement
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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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