Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fistula healing
研究概览
简要总结
This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.
详细描述
Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.
Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.
Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with trans-sphincteric and inter-sphincteric perianal fistulae
排除标准
- •Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula
结局指标
主要结局
Fistula healing
时间窗: January 2024
No leakage at all
次要结局
- Recurrence(January 2024)
- perianal abscess/fistula(January 2024)
