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Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU Amiens Picardie
Amiens, France
Hôpital Côte de Nacre - Chu Caen
Caen, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, France
CHU Henri Mondor
Créteil, France
CHU de Grenoble
Grenoble, France
Hôpital Claude Huriez
Lille, France
HCL - Hôpital Croix Rousse
Lyon, France
CHU de Marseille Hôpital de Timone
Marseille, France
l'Institut Paoli Calmettes
Marseille, France
Start Date
January 27, 2021
Primary Completion Date
April 27, 2023
Completion Date
January 27, 2026
Last Updated
February 22, 2022
340
ESTIMATED participants
hepatectomy
PROCEDURE
Lead Sponsor
Institut Mutualiste Montsouris
Collaborators
NCT06430957
NCT04668872
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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