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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03983174

Enrollment

100

Registered

2019-06-12

Start date

2017-01-01

Completion date

2019-04-30

Last updated

2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

Brief summary

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

Interventions

PROCEDUREDrainage seton with flap

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

PROCEDUREEAS sparing seton

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
fecal incontinence	12 months after surgery	Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026