Back to resultsRerouting Seton Versus LIFT for Complex Anal Fistula
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rerouting seton
LIFT
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
Inclusion Criteria:
- Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female
Exclusion Criteria:
- Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
- ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
- Patient with any grade of anal incontinence.
- Patients with concomitant anal pathology.
Sites / Locations
- Mansoura university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rerouting seton
LIFT
Arm Description
Placement of seton with rerouting of the fistula tract around the internal anal sphincter
Ligation of the intersphincteric fistula tract
Outcomes
Primary Outcome Measures
Clinical Healing of anal fistula
Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04616911
Brief Title
Rerouting Seton Versus LIFT for Complex Anal Fistula
Official Title
External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rerouting seton
Arm Type
Active Comparator
Arm Description
Placement of seton with rerouting of the fistula tract around the internal anal sphincter
Arm Title
LIFT
Arm Type
Active Comparator
Arm Description
Ligation of the intersphincteric fistula tract
Intervention Type
Procedure
Intervention Name(s)
Rerouting seton
Intervention Description
Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter
Intervention Type
Procedure
Intervention Name(s)
LIFT
Intervention Description
Ligation of the intersphincteric fistula tract
Primary Outcome Measure Information:
Title
Clinical Healing of anal fistula
Description
Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female
Exclusion Criteria:
Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
Patient with any grade of anal incontinence.
Patients with concomitant anal pathology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile, M.D., FACS
Phone
+201006267150
Email
sameh200@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D., FACS
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Phone
01006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rerouting Seton Versus LIFT for Complex Anal Fistula
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