Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- postoperative anal caliber
研究概览
简要总结
This prospective randomized study included 60 consecutive patients suffering from anal stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17 female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.
详细描述
Informed consent was obtained from all patients to be included in the study, after explanations the nature of the disease and possible treatment. This study was approved by local ethical committee.
The patients were then randomized into three groups. The randomization was achieved through computer-generated schedule and its results were sealed into 60 envelopes. The responsible surgeon opened randomly an envelop and, accordingly to the protocol.
Group 1: consists of 20 (14 males and 6 females) patients underwent house door flap.
Group II: consists of 20 patients (16 males and 4 females) underwent romboid flap.
Group III: consists of 20 patients underwent V-Y anoplasty (13 males and 7 females).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL PATIENTS with anal stenosis
排除标准
- •Pregnant female
- •Malignant stenosis
- •Associated anal pathology
- •Anal stenosis with a anal diameter more than 20 mm
结局指标
主要结局
postoperative anal caliber
时间窗: 1 year
次要结局
- clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life(1 year)