Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)
Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life
研究概览
地位
条件
详细说明
The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.
The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.
The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).
A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.
The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.
On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.
Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Paris、法国、75013
- Pitié-Salpêtrière Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥18 years old <= 80 years old
- Right colon cancer < T4 without metastasis
- <T4 N0M0
Exclusion Criteria:
- Pregnant patient
- T4 cancer
- Metastasis
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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1
laparoscopic surgery in right colon cancer operations
|
2
open surgery in right colon cancer operations
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Cost during the 2 postoperative years
大体时间:during the 2 postoperative years
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during the 2 postoperative years
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Mortality, morbidity and quality of life during the 2 postoperative years
大体时间:during the 2 postoperative years
|
during the 2 postoperative years
|
合作者和调查者
调查人员
- 首席研究员:Laurent Hannoun, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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