Back to resultsVideo-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula
Primary Purpose
Video Assisted Anal Fistula Treatment
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Sponsored by
About this trial
This is an interventional treatment trial for Video Assisted Anal Fistula Treatment
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.
Exclusion Criteria:
- We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Video-assisted anal fistula treatment (VAAFT
Fistula-tract Laser Closure (filac)
Conventional seton
Arm Description
Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula
Fistula-tract Laser Closure (filac)in the Management of anal fistula
Conventional seton in the Management of anal fistula
Outcomes
Primary Outcome Measures
recurrence of anal fistula
recurrence of anal fistula symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04418323
Brief Title
Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula
Official Title
Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 2, 2021 (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
5. Study Description
Brief Summary
Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video Assisted Anal Fistula Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video-assisted anal fistula treatment (VAAFT
Arm Type
Active Comparator
Arm Description
Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula
Arm Title
Fistula-tract Laser Closure (filac)
Arm Type
Active Comparator
Arm Description
Fistula-tract Laser Closure (filac)in the Management of anal fistula
Arm Title
Conventional seton
Arm Type
Active Comparator
Arm Description
Conventional seton in the Management of anal fistula
Intervention Type
Procedure
Intervention Name(s)
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Intervention Description
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Primary Outcome Measure Information:
Title
recurrence of anal fistula
Description
recurrence of anal fistula symptoms
Time Frame
one year
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:
Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.
Exclusion Criteria:
We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
drmhamdy@mans.edu.eg
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hamada Mohamed Hamada
Phone
+20 109 212 7930
Email
irb.mfm@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula
We'll reach out to this number within 24 hrs