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
About this trial
This is an interventional treatment trial for High Transsphincteric Perianal Fistula
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.
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
NCT ID
NCT02994524
First Posted
December 8, 2016
Last Updated
December 13, 2016
Sponsor
Yasser Mohamed Abdel-samii
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
Learn more about this trial
Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence
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