An interventional study of hepatectomy in Liver Metastasis Colon Cancer and Postoperative Complications, sponsored by Institut Mutualiste Montsouris. Status unknown at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Treatment
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.
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.
1,269 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.
This study's planned enrollment of 340 is above the median of 117 across 710 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Institut Mutualiste Montsouris is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Procedure: hepatectomy
standard of care
Procedure: hepatectomy
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
Rate of overall complications using the comprehensive complication Index (CCI)
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.
Time frame: Within 90 days postoperatively or at any time during hospitalization.
Proportion of patients presenting severe postoperative complications
Proportion of patients presenting severe postoperative complications rate as defined by the Clavien-Dindo classification ≥ grade 3 (including mortality) between patients treated with laparoscopic liver resection and those treated with open liver surgery
Time frame: Within 90 days postoperatively or at any time during hospitalization.
Rate of conversion from laparoscopy liver resection to open liver surgery
Conversion is defined as the requirement for laparotomy at any time of the procedure with the exception of the extraction of the resected specimen. Specific data regarding conversion will be noticed from the operative reports. These included the reasons for conversion, the timing of conversion and the type of conversion.
Time frame: during surgery.
Length of hospital stay
Length of hospital stay and occurrence of unplanned readmission after discharge,assessed by hospitalization reports
Time frame: Within 90 days postoperatively or at any time during hospitalization.
Delay of recovery before resuming professional activities.
Delay of recovery before resuming professional activities assessed by PQRS (Postoperative Quality Recovery Scale) including nociceptive domain, emotional domain, cognition domain and day-to-day activities at D-1, D1, D7, D30 and D90.
Time frame: Within 90 days postoperatively
Postoperative quality of life using quality of life questionnaries.
Patient-reported outcome measures were assessed with the validated European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire, EORTC Quality of Life Questionnaire (QLQ) -C30 (version 3.0), and the module dedicated to colorectal liver metastases (EORTC QLQ-LMC21). EQ5D-5L is a standardised measure of health status that provides a simple descriptive profile and a single index value suitable for the economic evaluation of health. It will be used to calculate the QALYs of each enrolled patient, by valuing health.
Time frame: At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.
Health economics analysis
A cost-effectiveness study will be performed and completed by a cost-utility analysis to identify the efficient therapeutic strategy (laparoscopic approach) ompared to the reference (open surgery). Only direct costs will be considered for treatments, management of side effects, medical transports, rehabilitation procedures and medical consultations. Out of hospital resources are valued from the Social Health Insurance (SHI) tariffs and hospital stays the Diagnosis-Related group (DRG) tariff taking into account additional daily fixed prices for ICU stay, if any.
Time frame: During the full participation period (3 years).
Oncologic quality of the resection using the pathological report.
Mean surgical margin widths (in millimeters). Percentages of microscopically complete (R0), microscopically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
Time frame: During surgery
Disease-free and overall survival at 3 years.
1. Percentage of patients with intrahepatic or extrahepatic recurrence three years after the operation. 2. Median disease-free survival time (in months). 3. Percentage of patients who died at 1, 2 and 3 years after the procedure. 4. Median overall survival time (in months).
Time frame: During the full participation period (3 years).
Plan to share: No
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Institut Mutualiste Montsouris