Back to resultsRCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LIFT
Parks
Seton
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
Inclusion Criteria:
- Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females
Exclusion Criteria:
- Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
- Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
- Patients on long-acting steroids or immunosuppressive drugs.
- Patients with fecal incontinence (FI)
- Patients with previous anorectal operations including surgery for previous anal fistula.
- Patients with ASA score (American society of anesthesiologists) of III and higher
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
LIFT
Parks
Seton
Arm Description
Ligation of intersphincteric fistula tract
Modified Parks technique
Two-stage seton placement
Outcomes
Primary Outcome Measures
Healing of anal fistula
complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04377542
Brief Title
RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
Official Title
Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.
This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.
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
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIFT
Arm Type
Active Comparator
Arm Description
Ligation of intersphincteric fistula tract
Arm Title
Parks
Arm Type
Active Comparator
Arm Description
Modified Parks technique
Arm Title
Seton
Arm Type
Active Comparator
Arm Description
Two-stage seton placement
Intervention Type
Procedure
Intervention Name(s)
LIFT
Intervention Description
Ligation of the fistula tract in the intersphincteric plane
Intervention Type
Procedure
Intervention Name(s)
Parks
Intervention Description
Modified Parks fistulotomy with complete internal anal sphincterotomy
Intervention Type
Procedure
Intervention Name(s)
Seton
Intervention Description
Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles
Primary Outcome Measure Information:
Title
Healing of anal fistula
Description
complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females
Exclusion Criteria:
Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
Patients on long-acting steroids or immunosuppressive drugs.
Patients with fecal incontinence (FI)
Patients with previous anorectal operations including surgery for previous anal fistula.
Patients with ASA score (American society of anesthesiologists) of III and higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
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