Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Pouch Function Score (PFS)
研究概览
简要总结
This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)
详细描述
Ileal Pouch-Anal Anastomosis (IPAAI in Ulcerative Colitis (UC) patients is usually performed by double-stapling technique after rectal transection with a linear stapler. Double-stapling is increasingly criticized for the uneven longer cuffs and potential weak points. The Transanal Transection and Single-Stapled (TTSS) approach may potentially overcome the limitations of double-stapling. A single-stapled anastomosis may be accomplished through a transanal rectal transection followed by bottom-up dissection (transanal-ileal pouch-anal anastomosis) or through an abdominal, rectal dissection and subsequent transanal transection and single-stapled anastomosis. TTSS-IPAA approach was shown to provide reduced rectal cuff length and reduced rate of urgency at six months after stoma closure. However, the retrospective and single-center features of these findings may prevent a robust conclusion about the superiority of TTSS-IPAA. The purpose of this study is to compare short-term and functional outcomes of double-stapling versus TTSS techniques for IPAA in UC patients in a prospective multicentric cohort study.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years old) patients diagnosed with drug-refractory and/or steroid-dependent UC scheduled for elective restorative proctectomy.
- •Patients scheduled for robotic or laparoscopic surgery
排除标准
- •Planned open surgery.
- •Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
结局指标
主要结局
Pouch Function Score (PFS)
时间窗: 6 months after surgery or stoma closure
Median difference of the Pouch Function Score (PFS) \[score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)\] between the study cohorts
次要结局
- Patients fit for stoma closure(12 months after surgery)
- Pouch complications(24 months after surgery or stoma closure)
- Pouch Function Score (PFS)(24 months after surgery or stoma closure)
- Postoperative complications(90 days after surgery)
- Anastomotic leak(90 days after surgery)
- Healthcare costs(12 months after surgery)
- Rectal cuff lenght(At surgery)
