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Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence

Primary Purpose

High Transsphincteric Perianal Fistula

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rerouting technique for transsphincteric perianal fistula
Sponsored by
Yasser Mohamed Abdel-samii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Transsphincteric Perianal Fistula

Eligibility Criteria

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

Inclusion Criteria:

  • High arching transsphincteric fistula
  • Transsphincteric fistula with high internal opening
  • Transsphincteric fistula with short anal canal.
  • Horseshoe perianal fistula fulfilling above criteria.

Exclusion Criteria:

  • Transsphincteric fistula.
  • Low perianal fistula.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    transsphincteric perianal fistula

    Arm Description

    Rerouting technique done in patients with high transsphincteric fistula or with high internal opening.

    Outcomes

    Primary Outcome Measures

    Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2016
    Last Updated
    December 13, 2016
    Sponsor
    Yasser Mohamed Abdel-samii
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02994524
    Brief Title
    Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yasser Mohamed Abdel-samii

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .
    Detailed Description
    Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Transsphincteric Perianal 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
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    transsphincteric perianal fistula
    Arm Type
    Other
    Arm Description
    Rerouting technique done in patients with high transsphincteric fistula or with high internal opening.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rerouting technique for transsphincteric perianal fistula
    Primary Outcome Measure Information:
    Title
    Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: High arching transsphincteric fistula Transsphincteric fistula with high internal opening Transsphincteric fistula with short anal canal. Horseshoe perianal fistula fulfilling above criteria. Exclusion Criteria: Transsphincteric fistula. Low perianal fistula.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence

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