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临床试验/NCT04006600
NCT04006600已完成不适用

Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery?

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Persistence of a stomy 2 years after rectal surgery when stoma was primarily intended to be temporary

研究概览

简要总结

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

详细描述

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Studies focused on surgical difficulties usually evaluated criteria such as, total surgery duration, blood loss or surgeon's subjective evaluation. The investigators of this retrospective study hypothesize that when a stoma,primarily intended to be temporary, is not reversed after a long (2 years) post operative delay, it all comes to surgical difficulties and that these surgical difficulties are essentially represented by anatomical constraints. Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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 patients who underwent a sphincter saving resection for low rectal cancer between January 2019 and December 2017.

排除标准

  • Minor patients.
  • Patients who have undergone a cancer proctectomy with no restoration of continuity expected.
  • Patients who did not have total Mesorectal excision

结局指标

主要结局

Persistence of a stomy 2 years after rectal surgery when stoma was primarily intended to be temporary

时间窗: 2 years

Number of patient with the persistence of a permanent stoma

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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