Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula: Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 72
- 主要终点
- Curation
研究概览
简要总结
Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results available with level 1 evidence. We compare the results of two conservative sphincter techniques: ligation of intersphincteric fistula tract (LIFT) versus RAF.
Material and Method: A controlled, randomised clinical trial is conducted in patients operated between 2013 and 2016 in Hospital General Universitario Reina Sofia, Murcia, Spain. The primary objective was to evaluate relapse at 12 months of follow-up, and the secondary objectives were post-op anal continence (Wexner), post-operative complications (haematoma, infection of surgical site, suture dehiscence), duration of surgery and hospitalisation. Post-operative controls 1, 3, 6 and 12 months after surgery.
详细描述
Material and method
Design:
Phase III, single centre, randomised, open-label, parallel group trial controlled with active comparator, with blind evaluation of results by a non-commercial third party. This study was conducted in 72 patients who had undergone complex anal fistula surgery and met the inclusion criteria.
The study was conducted by the Colo proctology Unit of the General and Digestive Surgery Department of Hospital General Universitario Reina Sofia, Murcia, Spain, from February 2013 to June 2016, and approved by the hospital's Independent Ethics Committee (IEC). The study was conducted pursuant to the principles of the Declaration of Helsinki (Seoul, October 2008) and the Good Clinical Practice (GP) standards of the European Economic Community's task force on the efficacy of medicinal substances (1990) and all legislation currently applicable in Spain (Royal Decree 223/2004 of 6 February).
Patients with a diagnosis or suspected diagnosis of anal fistula were referred to the Coloproctology Office. At the first visit, demographic data and a clinical history was obtained, followed by a physical examination of the anal region, with rigid anoscopy, ordering an endoanal ultrasound. At a second visit, if the diagnosis of complex anal fistula was confirmed, after providing information about the study, the patient was invited to participate, signed the consent form, and underwent the pre-operative Wexner scale. Patients were allocated a randomisation code for LIFT or RAF on the day of surgery. After surgery, controls were performed on days 7 and 14, by means of a symptoms diary to be completed by each patient, and 1, 3, 6 and 12 months after the surgery, with the Wexner scale calculated in the last control of each patient.
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
- Single (Outcomes Assessor)
盲法说明
Open
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
- •patient diagnosed with transsphincteric (medium or high) or suprasphincteric cryptoglandular anal fistula
- •with no abscess at the time of surgery
- •who agreed to participate and signed the informed consent form
- •capable transsphincteric understanding and following study instructions
排除标准
- •diagnosed with, or with a suspected diagnosis of, Crohn's disease
- •diagnosed with, or with a suspected diagnosis of, malignant anal tumour
- •diagnosed with, or with a suspected diagnosis of,tuberculosis or suppurative hidradenitis
- •a history of radiotherapy of the ano-perineal region
- •language difficulties that prevent comprehension of the study
- •refusal to participate
结局指标
主要结局
Curation
时间窗: 1 year
Proportion of subjects in each treatment group without fistula recurrence after surgery
次要结局
- Security(1 month)
- Time of recurrence(10 years)
- Functionality(1 year)
- Time of surgery(1 day)
研究者
Jorge Alejandro Benavides Buleje
Principal Investigator
Hospital General Universitario Reina Sofía de Murcia