Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

NCT ID: NCT03983174

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-04-30

Brief Summary

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Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton

Detailed Description

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Conditions

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Anal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Drainage seton with flap

Drainage seton will be put around the external anal sphincter with mucosal advancement flap

Group Type EXPERIMENTAL

Drainage seton with flap

Intervention Type PROCEDURE

Seton is placed around the external sphincter then mucosal advancement flap will be constructed

EAS sparing seton

Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done

Group Type EXPERIMENTAL

EAS sparing seton

Intervention Type PROCEDURE

Rerouting of the seton around the internal sphincter only sparing the external sphincter

Interventions

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Drainage seton with flap

Seton is placed around the external sphincter then mucosal advancement flap will be constructed

Intervention Type PROCEDURE

EAS sparing seton

Rerouting of the seton around the internal sphincter only sparing the external sphincter

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from high trans-sphincteric anal fistula

Exclusion Criteria

* Acute sepsis.
* Specific cause of fistula e.g. Crohn's disease
* Strictured anorectum.
* Any degree of incontinence
* Recurrent anal fistula.
* Low anal fistula.
* Previous anorectal surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mansoura102

Identifier Type: -

Identifier Source: org_study_id

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