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Completed

NCT Number: NCT06478615

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Coring out Fistulectomy with Closure of Internal Sphincter Opening

Procedure

The patient was laid in the lithotomy position. Skin preparation and draping were done. Normal saline irrigation was performed. The anal canal was sufficiently dilated to permit the introduction of a self-retaining retractor. With H2O2 injection into the fistula tract, the internal opening and tract of the fistula will be identified. The incision was made around the external opening, and the tract was all cored out along the tract from the external opening to the internal sphincter. Meticulous hemostasis will be performed, stay suture by PDS 4/0 around fistiolous opening at the internal sphincter, excision of fistulous tract above stay suture, then closure of internal sphincter defect by PDS 3/0. Anal packing with 4 × 4 epinephrine gauze and sterile protective dressing was performed. After the operation, a stool softener and pain controller were prescribed, and patients were discharged.

Lay Open Fistulotomy and Primary Sphincter Repair

Procedure

Patients were put in a lithotomy position and the skin was then draped. After identification of the external fistula orifice probing of the fistula tract with identification of the fistulous tract and internal orifice with H2O2 injection into the fistula tract. The fistula was laid open and fistulectomy was then conducted and dissected with diathermy cautery help. Then Primary repair of the sphincter with PDS 3/0 with proper hemostasis using coagulation diathermy.

Primary outcomes

  1. Incidence of recurrence of perianal fistula

    Time frame: 3 months postoperatively

    Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months.

Secondary outcomes

  1. Incidence of stool incontinence

    Time frame: 3 months postoperatively

    Incidence of stool incontinence was recorded for 3 months.

  2. Healing time

    Time frame: 3 months postoperatively

    Healing was defined as cicatrization of all wounds without discharge at 3 months

  3. Length of hospital stay

    Time frame: 1 week postoperatively

    Length of hospital stay was recorded from admission till discharge from hospital.

  4. Complications

    Time frame: 3 months postoperatively

    Complications such as (blood loss, pain, bleeding, discharge, urinary retention, urgency, wound infection) were recorded.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Jun 28, 2024

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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