NCT02994524

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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

2.1 years

First QC Date

December 8, 2016

Last Update Submit

December 13, 2016

Conditions

High Transsphincteric Perianal Fistula

Outcome Measures

Primary Outcomes (1)

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

    one year

Study Arms (1)

transsphincteric perianal fistula

OTHER

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

Procedure: Rerouting technique for transsphincteric perianal fistula

Interventions

Rerouting technique for transsphincteric perianal fistulaPROCEDURE
transsphincteric perianal fistula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Transsphincteric fistula.
  • Low perianal fistula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 16, 2016

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12