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临床试验/NCT04248634
NCT04248634已完成不适用

Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection

Institut National d'Oncologie, Morocco1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月1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
20
试验地点
1
主要终点
Stoma rate at 90 days

研究概览

简要总结

After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life.

Delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy.

In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.

详细描述

After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. The latter reduces the risk and severity of clinical anastomotic fistulas. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity reaching up to 30% of patients, a deterioration in the quality of life and the need for a second surgery to restore digestive continuity. And specifically in low-income countries, ostomy bags are expensive and are not reimbursed, and therefore constitute a heavy burden for Moroccan patients.

In order to overcome these drawbacks, delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. This technique consists of externalizing the colon in the first stage by the transanal route, without creating an ileostomy, and waiting a week for the creation of the anastomosis. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy. Several studies have shown encouraging results in the short and midterm, and it is listed among the technical options in the French recommendations for the management of rectal cancer.

In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.

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 patients> 18 years old.
  • Rectal resection with the creation of a delayed colo-anal anastomosis.

排除标准

  • 未提供

结局指标

主要结局

Stoma rate at 90 days

时间窗: 90 days

The rate of patients who required a stoma creation at 90 days

Perineal complications

时间窗: 90 days

Rates of perineal complications at 90 days after surgery

次要结局

  • Quality of life assessement: EORTC QLQ30 score(12 months)
  • Functional outcomes(12 months)
  • Clavien-Dindo complications(90 days)

研究者

发起方
Institut National d'Oncologie, Morocco
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anass Majbar

Professor of surgery

Institut National d'Oncologie, Morocco

研究点 (1)

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