The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.
Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed
Time to functional recovery
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.
Time frame: Expected average of 4 to 12 days postoperatively
R0 resection margin
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Time frame: 30 days postoperatively
Length of hospital stay
The length of hospital stay for the surgical procedure(s)
Time frame: 30 days postoperatively
Activity tracking using Fitbit™
A patient's functional recovery will also be assessed using the Fitbit smartwatch.
Time frame: 14 days pre-operatively and 60 days postoperatively
Intraoperative blood loss
Intraoperative blood loss in milliliters
Time frame: During the surgical procedure
Operative time
Operative time in minutes
Time frame: Operative time from incision until last suture
Morbidity
Morbidity related to the surgical procedure(s)
Time frame: 90-days postoperatively
Postoperative bile leakage
Bile leakage occurring after the liver resection
Time frame: 90-days postoperatively
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
NOT_YET_RECRUITINGGeneral Hospital Groeninge
Kortrijk, West Flanders, Belgium
RECRUITINGAntoine-Béclère Hospital
Paris, Île-de-France Region, France
NOT_YET_RECRUITINGKlinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
Saarbrücken, Saarland, Germany
RECRUITINGFederico II University Hospital
Naples, Calabria, Italy
NOT_YET_RECRUITINGAzienda USL di Bologna
Bologna, Emilia-Romagna, Italy
RECRUITINGAzienda Ospedaliero-Universitaria di Modena
Modena, Emilia-Romagna, Italy
NOT_YET_RECRUITINGParma University Hospital
Parma, Emilia-Romagna, Italy
NOT_YET_RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
RECRUITINGFondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, Italy
RECRUITING...and 18 more locations
Postoperative anastomotic leakage
Anastomotic leakage occurring after the colorectal resection
Time frame: 90-days postoperatively
Conversion to open surgery
Intra-operative conversion to an open or hand-assisted procedure
Time frame: During the surgical procedure
Readmission rate
Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)
Time frame: 90-days postoperatively
Health-Related Quality of Life
The physical, social and emotional well-being of the patient; assessed using the EuroQol 5d and European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 instruments.
Time frame: 1 year postoperatively
Reasons for delay of discharge after functional recovery
All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.
Time frame: 30 days postoperatively
Hospital and societal costs
All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.
Time frame: 1 year postoperatively
Three and five-year recurrence free survival
The proportion of patients which is free of recurrence of the malignant disease after resection of both the primary colorectal carcinoma and the liver metastases.
Time frame: 5 years postoperatively
Three and five-year overall survival
The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.
Time frame: 5 years postoperatively