Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent
排除标准
- •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
研究组 & 干预措施
Transanal Opening of the Intersphincteric Space (TROPIS)
patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS)
干预措施: Transanal opening of intersphincteric space (TROPIS) (Procedure)
Coring Out Fistulectomy
patient with high anal fistula will be treated with Coring Out Fistulectomy
干预措施: Coring Out Fistulectomy (Procedure)
结局指标
主要结局
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula
时间窗: Up to 4 months postoperatively
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula (failure of healing or recurrence of anal fistula), Early results
次要结局
- Operative time(During surgery)
- Hospitalization period(From surgery until discharge)
- surgical site infection(Up to 4 months postoperatively)
- postoperative fecal incontinence(Up to 4 months postoperatively)
- Operative time(During surgery)
- Postoperative urine retention(Within 48 hours postoperatively)
- Pain intensity(At day 1 and day 7 postoperatively)
- Hospitalization period(From surgery until discharge)
- surgical site infection(Up to 4 months postoperatively)
- postoperative fecal incontinence(Up to 4 months postoperatively)
- Time to return to normal activity(Up to 4 months postoperatively)
- Time for wound Healing(Up to 4 months postoperatively)
- Postoperative bleeding(Up to 4 months postoperatively)
研究者
Ahmed Mohamed Abdelaal
lecturer
Cairo University