NCT03595839已完成不适用
Fistuolotomy With or Without Marsupialization for Treatment of Simple Anal Fistula: a Randomized Controlled Trial
适应症
干预措施
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
- Time to complete healing
研究概览
简要总结
Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Age: 18-65 years
- •All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).
排除标准
- •High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
- •Recurrent anal fistulas.
- •Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
- •High risk patients according to ASA (American society of anesthesiologists )
- •Any degree of incontinence.
- •Patients with previous anal surgery.
研究组 & 干预措施
Fistulotomy with Marsupialization
Active Comparator
Lay open and Marsupialization of the fistula track
干预措施: Fistulotomy (Procedure)
Fistulotomy with Marsupialization
Active Comparator
Lay open and Marsupialization of the fistula track
干预措施: Marsupialization (Procedure)
Fistulotomy without Marsupialization
Active Comparator
lay open of the fistula track
干预措施: Fistulotomy (Procedure)
结局指标
主要结局
Time to complete healing
时间窗: 8 weeks
The duration of time required to achieve complete wound healing
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University
研究点 (2)
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