Treatment of Complex Anal Fistula With Draining Seton Wit... | NCT03636997

Studies
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track

NCT03636997

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 17, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Anal Fistula

Interventions

Draining seton
Rerouting of track

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Jul 30, 2018Actual

First Submitted Date

Aug 16, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sameh Emile, Lecturer of general surgery, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula

Detailed Description

Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.

The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Draining seton	Active Comparator	Draining seton is placed through the fistula track and internal and external anal sphicnters	Procedure: Draining seton
Rerouting of track	Active Comparator	The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter	Procedure: Rerouting of track

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Draining seton	Procedure	Number 1 silk suture was passed through the fistula track and tied as loose seton	Draining seton

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing time	Time required to achieve complete healing of the anal fistula	6 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula

Exclusion Criteria:

Patients with simple anal fistula.
Patients with acute anorectal sepsis.
Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
Patients with history of previous surgical treatment of anal fistula.
Patients with symptomatic preoperative fecal incontinence.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameh Emile, M.D.	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate	35516	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31162376	Derived	Omar W, Alqasaby A, Abdelnaby M, Youssef M, Shalaby M, Anwar Abdel-Razik M, Emile SH. Drainage Seton Versus External Anal Sphincter-Sparing Seton After Rerouting of the Fistula Tract in the Treatment of Complex Anal Fistula: A Randomized Controlled Trial. Dis Colon Rectum. 2019 Aug;62(8):980-987. doi: 10.1097/DCR.0000000000001416.

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases