Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases

Institut Mutualiste Montsouris340 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

Liver Metastasis Colon Cancer Postoperative Complications

Interventions

hepatectomyPROCEDURE

Resection colorectal liver metastases using a laparoscopic approach or an open approach.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (21)

CHU Amiens Picardie

Amiens, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Central Contacts

Caroline RIX

CONTACT

+33 156616371 caroline.rix@imm.fr

Nassima OUDAFAL

CONTACT

+33 156616675 nassima.oudafal@imm.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.