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Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula

A

Ain Shams University

Status

Completed

Conditions

Fistulectomy
Transsphincteric Perianal Fistula
Lay Open Fistulotomy
Sphincter Repair
Coring Out
Internal Sphincter

Treatments

Procedure: Coring out Fistulectomy with Closure of Internal Sphincter Opening
Procedure: Lay Open Fistulotomy and Primary Sphincter Repair

Study type

Interventional

Funder types

Other

Identifiers

NCT06478615
30/10/2022

Details and patient eligibility

About

This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula

Full description

Fistula-in-ano is a common medical problem affecting thousands of patients annually. Symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric.

Conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. A transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter.

Coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age more than 18 years old.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I, II.
  • Fistula in ano, Trans-sphincteric type

Exclusion criteria

  • Patients with low perianal fistula.
  • Recurrent perianal fistula.
  • Associated anal conditions such as (piles, anal fissures, and rectal prolapse).
  • Patients with inflammatory bowel disease or tuberculosis.
  • Patients with acute perianal abscess.
  • Patients with major incontinence.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Coring out Fistulectomy with Closure of Internal Sphincter Opening
Experimental group
Description:
Patients underwent coring out fistulectomy with closure of internal sphincter opening
Treatment:
Procedure: Coring out Fistulectomy with Closure of Internal Sphincter Opening
Lay Open Fistulotomy and Primary Sphincter Repair
Experimental group
Description:
Patients underwent lay open fistulotomy and primary sphincter repair
Treatment:
Procedure: Lay Open Fistulotomy and Primary Sphincter Repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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