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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet study): study protocol for a randomized controlled trial

Authors: Åsmund Avdem Fretland, Airazat M Kazaryan, Bjørn Atle Bjørnbeth, Kjersti Flatmark, Marit Helen Andersen, Tor Inge Tønnessen, Gudrun Maria Waaler Bjørnelv, Morten Wang Fagerland, Ronny Kristiansen, Karl Øyri, Bjørn Edwin

Published in: Trials | Issue 1/2015

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Abstract

Background

Laparoscopic liver resection is used in specialized centers all over the world. However, laparoscopic liver resection has never been compared with open liver resection in a prospective, randomized trial.

Methods/Design

The Oslo-CoMet Study is a randomized trial into laparoscopic versus open liver resection for the surgical management of hepatic colorectal metastases. The primary outcome is 30-day perioperative morbidity. Secondary outcomes include 5-year survival (overall, disease-free and recurrence-free), resection margins, recurrence pattern, postoperative pain, health-related quality of life, and evaluation of the inflammatory response. A cost-utility analysis of replacing open surgery with laparoscopic surgery will also be performed. The study includes all resections for colorectal liver metastases, except formal hemihepatectomies, resections where reconstruction of vessels/bile ducts is necessary and resections that need to be combined with ablation. All patients will participate in an enhanced recovery after surgery program. A biobank of liver and tumor tissue will be established and molecular analysis will be performed.

Discussion

After 35 months of recruitment, 200 patients have been included in the trial. Molecular and immunology data are being analyzed. Results for primary and secondary outcome measures will be presented following the conclusion of the study (late 2015). The Oslo-CoMet Study will provide the first level 1 evidence on the benefits of laparoscopic liver resection for colorectal liver metastases.

Trial registration

The trial was registered in ClinicalTrals.gov (NCT01516710) on 19 January 2012.
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Metadata
Title
Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet study): study protocol for a randomized controlled trial
Authors
Åsmund Avdem Fretland
Airazat M Kazaryan
Bjørn Atle Bjørnbeth
Kjersti Flatmark
Marit Helen Andersen
Tor Inge Tønnessen
Gudrun Maria Waaler Bjørnelv
Morten Wang Fagerland
Ronny Kristiansen
Karl Øyri
Bjørn Edwin
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0577-5

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