Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
France
CHU Amiens Picardie
NOT_YET_RECRUITING
Amiens
Hôpital Côte de Nacre - Chu Caen
NOT_YET_RECRUITING
Caen
CHU Estaing
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Beaujon
RECRUITING
Clichy
CHU Henri Mondor
RECRUITING
Créteil
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
Hôpital Claude Huriez
NOT_YET_RECRUITING
Lille
HCL - Hôpital Croix Rousse
NOT_YET_RECRUITING
Lyon
CHU de Marseille Hôpital de Timone
NOT_YET_RECRUITING
Marseille
l'Institut Paoli Calmettes
NOT_YET_RECRUITING
Marseille
CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
CHU de Nancy - Hôpitaux Brabois
NOT_YET_RECRUITING
Nancy
Hôpital Cochin
RECRUITING
Paris
Hôpital La pitié Salpêtrière
RECRUITING
Paris
Institut Mutualiste Montsouris
RECRUITING
Paris
CHU de Reims
NOT_YET_RECRUITING
Reims
Hôpital Charles Nicolle
NOT_YET_RECRUITING
Rouen
CHU de Strasbourg - Nouvel Hôpital Civil
NOT_YET_RECRUITING
Strasbourg
CHU Rangueil
NOT_YET_RECRUITING
Toulouse
Hôpital Trousseau
NOT_YET_RECRUITING
Tours
Hôpital Paul Brousse
RECRUITING
Villejuif
Contact Information
Primary
Caroline RIX
caroline.rix@imm.fr
+33 156616371
Backup
Nassima OUDAFAL
nassima.oudafal@imm.fr
+33 156616675
Time Frame
Start Date: 2021-01-27
Estimated Completion Date: 2026-01-27
Participants
Target number of participants: 340
Treatments
Other: 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.
Other: open liver resection
standard of care
Related Therapeutic Areas
Sponsors
Leads: Institut Mutualiste Montsouris
Collaborators: Ministry of Health, France, National Cancer Institute, France