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

High Transsphincteric Perianal Fistula Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994524
• Other study ID #: 06379
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 13, 2016
• Start date: February 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• High Transsphincteric Perianal Fistula
• Rectal Fistula

Intervention

Procedure:
• Rerouting technique for transsphincteric perianal fistula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yasser Mohamed Abdel-samii

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .		one year	Yes