Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Global postoperative morbidity in both arms
研究概览
简要总结
The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy
详细描述
The present study is a national, multicenter, open-label randomized, 2-arm superiority trial. Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy or laparotomy. All patients that might be included will have a comprehensive geriatric assessment performed within the 30 days before randomization with the following scores: MMS (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test ("Timed Get-Up-and-Go" test).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years
- •Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
- •Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage)
- •No previous colonic cancer within the 5 last years
- •No peritoneal carcinosis on CT-scan
- •Patient able to fill in an auto-questionnaire alone or with some help
- •MMS (Mini Mental Score) ≥ 15
- •Given oral consent (formal informed consent is not required by French law for accepted procedures)
排除标准
- •Rectal cancer (≤ 15 cm from the anal margin)
- •Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
- •Synchronous colonic cancer
- •Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
- •Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
- •Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
- •Estimated life expectancy less than 6 months
- •Patient under guardianship
- •Other known active cancer (except nonmelanomatous skin cancer)
- •Patient not affiliated to the social security system
- •Previous colonic resection
研究组 & 干预措施
Laparotomy
Open surgery
干预措施: Laparotomy (Procedure)
Laparoscopy
Minimally invasive surgery
干预措施: Laparoscopy (Procedure)
结局指标
主要结局
Global postoperative morbidity in both arms
时间窗: At 30 days after the surgery
Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then
次要结局
- Postoperative mortality(Evaluated at 30 days and at 90 days after the surgery)
- Number of examined lymph nodes(At surgery)
- Type of resection (R0 or R1)(At surgery)
- Pathological evaluation of mesocolic resection quality(At surgery)
- Rate of readmission(Within the 30 days after discharge of the patient)
- Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)(At randomization and three months postoperatively)
- Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)(At randomization and three months postoperatively)
- Mini Mental State (MMS) Examination or Folstein test(Before randomization and three months postoperatively)
- Katz Activities of Daily Living (ADL) scale(Before randomization and three months postoperatively)
- Geriatric Depression Scale (GDS)(Before randomization and three months postoperatively)
- Timed Get-up-and-go (TGUG)(Before randomization and three months postoperatively)