Re-routing in Treatment High Anal Fistula
Primary Purpose
Anal Fistula
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rerouting of the track in high anal fitula
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
Inclusion Criteria:- patients with high anal fistula admitted at Asuit University Hospital at the period of study
Exclusion Criteria:- Any case with low anal fistula
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rerouting of track of high anal fistula
Arm Description
Outcomes
Primary Outcome Measures
evaluation the role of rerouting of the track in high anal fistula in treatemt
: collect result and see recurance and incontinence rate.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05476146
Brief Title
Re-routing in Treatment High Anal Fistula
Official Title
Re-routing of the Track in the Treatment of High Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?
Detailed Description
Anal fistula is a very common perianal condition associated with considerable morbidity and inconvenience to the patient. It is hollow tract lined with granulation tissue that connects an in-depth primary opening inside the anal canal to a superficial secondary opening in the perianal skin. It is mostly nonspecific infection of an anal gland in the intersphincteric space as the initiating pathology Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy into intersphincteric, trans-sphincteric, and supra-sphincteric or extra-sphincteric Surgical therapy is the main method used to treat anal fistula. The best treatment criterion is to eradicate the infected lesion, ensure sufficient drainage, and promote the closure of the fistula, while minimizing damage to the anal sphincter.
High anal fistulas require more complex treatment when compared to low anal fistula because of their complexity.
Rerouting is a transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. The newly posi-tioned intersphincteric fistula is then dealt with at a later date when the external sphincter is soundly healed .
The advantages of rerouting over other techniques in patients with high anal fistulae; patients had satisfactory results, decrease recurrence of fistulae or abscess formation. Healing is rapid, short hospital stay and continence to flatus and faeces preserved
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rerouting of track of high anal fistula
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rerouting of the track in high anal fitula
Intervention Description
Treatment of high anal fistula by rerouting
Primary Outcome Measure Information:
Title
evaluation the role of rerouting of the track in high anal fistula in treatemt
Description
: collect result and see recurance and incontinence rate.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- patients with high anal fistula admitted at Asuit University Hospital at the period of study
Exclusion Criteria:- Any case with low anal fistula
12. IPD Sharing Statement
Learn more about this trial
Re-routing in Treatment High Anal Fistula
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