An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Anal fistula recurrence rate
研究概览
简要总结
The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.
详细描述
A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years of age or more)
- •Single anal fistula
- •Surgically treated with anal fistula plug or endorectal advancement flap
排除标准
- •Children or adolescents
- •Pregnancy
- •Patients treated with setons alone
研究组 & 干预措施
Recurrent anal fistula
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
干预措施: Anal Fistula Plug (Procedure)
No recurrence of anal fistula
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
干预措施: Endorectal Advancement Flap (Procedure)
Recurrent anal fistula
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
干预措施: Endorectal Advancement Flap (Procedure)
No recurrence of anal fistula
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
干预措施: Anal Fistula Plug (Procedure)
结局指标
主要结局
Anal fistula recurrence rate
时间窗: One year
次要结局
- Independent factors predicting higher costs(One year)
- Cost(3 days)
- Complication rate(3 days)
- Independent factors predicting fistula recurrence(One year)
- Length of hospital stay(3 days)