A Prospective Non-comparative Study to evaluate the efficacy and safety of BEST Balloon Expansion and Separation Technique Surgery by using special tube drain called as BEST device in all types of complex fistula in ano
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate the time to heal anal fistula
研究概览
简要总结
A prospective,non comparative,single center, study to evaluate the efficacy and safety of BEST (Balloon Expansion And Seperator Technique) surgery by using special drain tube called as BEST device in all types of complex fistula in ano. Total 50 patients to be enrolled in study including patients suffering from complex fistulas.Study duration will be 12 months for each patients. ICF will be given on time of screening. Pre-operatve details regarding demographics,clinical findings,diagnostic imaging will be recorded. Intraoperative settings & findings will be noted.Post operative course including complications,hospital stay,recurrence.etc.will be recorded.Patients will be followed up at 1,3,6 & 12 month duration.Follow up taken will be based on questionnaires(Wexner fecal Incontinence Score and VAS pain score).Recurrence will be noted at a minimum of 12 month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18-80 years Patients with all types of complex fistula fistula associated with multiple tracts horse shoe fistulas Recurrent fistulas anterior fistulas in females fistula with long tracts Fistula with supralevator blind extension fistula where internal opening cannot be localised fistula associated with abscess or pus collection.
排除标准
- •Uncomplicated fistula cured by simple fistulotomy history of inflammatory bowel disease Chronic immunosuppresive treatment untreated cancer or cancer treated or dignosed within 6 months Incompetent subject pregnancy any clinical condition,according to the investigator which does not allow safe fulfillment of the study protocol.
结局指标
主要结局
Evaluate the time to heal anal fistula
时间窗: 6 months
Evaluate and compare VAS pain score
时间窗: 6 months
To evaluate anal fistula recurrence rate
时间窗: 6 months
次要结局
- To correlate preoperative endoscopic findings with intraoperative findings(To determine length of hospital stay)