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

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

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drainage seton with flap

Procedure

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

EAS sparing seton

Procedure

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

Primary outcomes

fecal incontinence

Time frame: 12 months after surgery

Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Jun 12, 2019
Registry last updated: Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed