Clinical trial NCT06478615: Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula
Official title: Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula; A Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coring Out
Fistulectomy
Internal Sphincter
Lay Open Fistulotomy
Sphincter Repair
Transsphincteric Perianal Fistula
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of recurrence of perianal fistula
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Incidence of stool incontinence
timeFrame: 3 months postoperatively
measure: Healing time
timeFrame: 3 months postoperatively
measure: Length of hospital stay
timeFrame: 1 week postoperatively
measure: Complications
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: