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临床试验/NCT06331637
NCT06331637尚未招募不适用

Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年7月31日最近更新:
适应症

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

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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.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)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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