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

M

Mansoura University

Status

Completed

Conditions

Anal Cancer

Treatments

Procedure: EAS sparing seton
Procedure: Drainage seton with flap

Study type

Interventional

Funder types

Other

Identifiers

NCT03983174
Mansoura102

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Drainage seton with flap
Experimental group
Description:
Drainage seton will be put around the external anal sphincter with mucosal advancement flap
Treatment:
Procedure: Drainage seton with flap
EAS sparing seton
Experimental group
Description:
Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done
Treatment:
Procedure: EAS sparing seton

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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