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临床试验/NCT03487484
NCT03487484终止不适用

Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
1
主要终点
Change in quality of life specific for the gastrointestinal tract

研究概览

简要总结

The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

详细描述

In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • age older than 18,
  • low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
  • German speaking patient who is capable to fill in the questionnaire,
  • signed informed consent

排除标准

  • age younger than 18,
  • preoperative stoma,
  • not German speaking
  • inability to fill in the questionnaire,
  • no standardized chemo- and radiotherapy

结局指标

主要结局

Change in quality of life specific for the gastrointestinal tract

时间窗: at Baseline and up to 12 months after surgery

GIQLI Score

次要结局

  • Change in quality of life(at Baseline and up to 12 months after surgery)
  • Change in faecal Incontinence(at Baseline and up to 12 months after surgery)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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