TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

Официальное название

Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial

Обзор

High anal fistulas represent a surgical challenge due to high recurrence rates and risk of postoperative fecal incontinence. Several sphincter-preserving techniques have been developed to address these issues. Coring Out fistulectomy is a traditional sphincter-saving approach, while Transanal Opening of the Intersphincteric Space (TROPIS) is a recently introduced technique with promising outcomes. This randomized clinical trial aims to compare the efficacy, safety, and patient outcomes of TROPIS versus coring out fistulectomy in the management of high complex anal fistulas.

Подробное описание

Fistula-in-ano is an abnormal epithelialized tract connecting the anal canal to the perianal skin, most commonly caused by cryptoglandular infection. High anal fistulas, involving more than one-third of the sphincter complex, carry a significant risk of postoperative incontinence when treated with fistulotomy. As a result, sphincter-preserving techniques have introduced.

Coring out fistulectomy allows excision of the fistulous tract while preserving sphincter integrity but has variable recurrence rates. TROPIS involves transanal opening of the intersphincteric space with complete preservation of the external anal sphincter and has shown high success rates in recent studies.

This prospective randomized clinical trial compares TROPIS and coring out fistulectomy regarding Failure rate (defined as failure of healing or recurrence of anal fistula), operative time, time for wound healing and postoperative complications including fecal incontinence.

Вмешательства

• Процедура Transanal opening of intersphincteric space (TROPIS)
  The fistula tracts on both sides of the External anal sphincter (EAS) are separately dealt with. A curved artery forceps is inserted in the fistula tract in the intersphincteric space through the internal opening.The mucosa and the internal sphincter overlying the artery forceps are then incised with electrocautery. The edges of the resulting wound are trimmed and A gutter is made inferiorly from the opened-up intersphincteric space to the anal verge to facilitate drainage from the intersphincte
• Процедура Coring Out Fistulectomy
  Incision was made around external opening.Coring out the fistulous track using a combination of cutting and coagulation diathermy from external opening to internal opening with closure of internal opening

Первичные конечные точки

• Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula [Срок оценки: Up to 4 months postoperatively]

Вторичные конечные точки (9)

• Operative time [Срок оценки: During surgery]
• Hospitalization period [Срок оценки: From surgery until discharge]
• surgical site infection [Срок оценки: Up to 4 months postoperatively]
• Time for wound Healing [Срок оценки: Up to 4 months postoperatively]
• Postoperative bleeding [Срок оценки: Up to 4 months postoperatively]
• postoperative fecal incontinence [Срок оценки: Up to 4 months postoperatively]
• Time to return to normal activity [Срок оценки: Up to 4 months postoperatively]
• Postoperative urine retention [Срок оценки: Within 48 hours postoperatively]
• Pain intensity [Срок оценки: At day 1 and day 7 postoperatively]

Критерии участия

Критерии включения

• Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent

Критерии исключения

• Patients with fistula secondary to malignancy, inflammatory bowel disease, trauma or radiation
• Patients with Low anal fistula
• Patient with preoperative fecal incontinence
• Previous levator ani muscle injury

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of medicine Cairo University — Cairo

Идентификаторы

NCT: NCT07334678 · MS-311-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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