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临床试验/NCT01111708
NCT01111708Unknown不适用

Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa Compared to the Ileo Neo Rectal Anastomosis and the Ileo Pouch Anal Anastomosis

University Medical Center Nijmegen2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups.

研究概览

简要总结

The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).

详细描述

Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.

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

性别
All
接受健康志愿者

入选标准

  • UC patients with the CRD procedure with written informed consent.
  • Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.

排除标准

  • Pregnancy
  • Malignancy
  • Psychiatric disease or inability to assess follow-up

结局指标

主要结局

To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups.

时间窗: 1 year

次要结局

  • Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.(1 year)

研究者

发起方
University Medical Center Nijmegen
申办方类型
Other

研究点 (2)

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