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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 25, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Assiut University
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    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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