Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 21
- 主要终点
- Rate of overall complications using the comprehensive complication Index (CCI)
研究概览
简要总结
The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.
详细描述
While laparotomy is still the standard approach of resectable colorectal liver mestastases, its associated morbidity remains non-negligible with reported mortality and complications rates ranging from 2 to 8% and 30 to 70%, respectively (1). Besides the underlying liver disease together with the comorbidities of the patients, this high morbidity is also related to the type of surgical approach. Since less than 15% of liver resections are currently performed using the laparoscopic approach in France, a trial showing the superiority of the laparoscopic approach in comparison to the open approach for patients with colorectal liver metastases qualifying for both approaches would allow improving management of patients, reducing the length of stay, maybe decreasing the global cost and changing current practices on a national scale.
In order to demonstrate the superiority of the laparoscopic approach over the laparotomy approach, patients with colorectal hepatic metastasis will be randomly assigned to either the laparoscopy or laparotomy groups. Post-operative complications (including mortality) will be measured using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization. The participation time for each patient in the study is 3 years, the patient will be followed at 1, 3, 6, 9, 9, 12, 15, 18, 21, 24, 30 and 36 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation.
- •Qualifying for both a laparoscopic approach and an open approach.
- •Informed written consent.
- •Affiliated to health insurance regimen.
排除标准
- •Hybrid liver resection (including both laparoscopic and open resection).
- •Liver resection requiring an associated vascular or biliary reconstruction.
- •Contraindication to surgery.
- •Contraindication to laparoscopy (pneumoperitoneum).
- •ASA (American Society of Anesthesiologists) score IV or V or life expectancy < 3 months.
- •Poor comprehension of French language or cognitive impairment
- •Pregnancy or breastfeeding.
- •Patient under guardianship or unable to give consent
- •People particularly protected by French law.
研究组 & 干预措施
laparoscopic liver resection
Laparoscopy allows some surgical procedures to be performed through small incisions that enable the operator to access the abdominal cavity, often at the pubic area, and surgical instruments are introduced through these small incisions. This technique avoids large abdominal incisions and significantly reduces the duration of hospitalization.
干预措施: hepatectomy (Procedure)
open liver resection
standard of care
干预措施: hepatectomy (Procedure)
结局指标
主要结局
Rate of overall complications using the comprehensive complication Index (CCI)
时间窗: Within 90 days postoperatively or at any time during hospitalization.
CCI is calculated using the burden of postoperative complications weighted with a measure of the severity according to the widely accepted Dindo-Clavien classification of postoperative complications and a dedicated CCI calculator.
次要结局
- Rate of conversion from laparoscopy liver resection to open liver surgery(during surgery.)
- Postoperative quality of life using quality of life questionnaries.(At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.)
- Proportion of patients presenting severe postoperative complications(Within 90 days postoperatively or at any time during hospitalization.)
- Length of hospital stay(Within 90 days postoperatively or at any time during hospitalization.)
- Delay of recovery before resuming professional activities.(Within 90 days postoperatively)
- Disease-free and overall survival at 3 years.(During the full participation period (3 years).)
- Health economics analysis(During the full participation period (3 years).)
- Oncologic quality of the resection using the pathological report.(During surgery)