title: Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial was registered in ClinicalTrals.gov (NCT01516710) on 19 January 2012.
authors: Åsmund Avdem
authors: ÅA
authors: Fretland
authors: Airazat M
authors: AM
authors: Kazaryan
authors: Bjørn Atle
authors: BA
authors: Bjørnbeth
authors: Kjersti
authors: K
authors: Flatmark
authors: Marit Helen
authors: MH
authors: Andersen
authors: Tor Inge
authors: TI
authors: Tønnessen
authors: Gudrun Maria Waaler
authors: GM
authors: Bjørnelv
authors: Morten Wang
authors: MW
authors: Fagerland
authors: Ronny
authors: R
authors: Kristiansen
authors: Karl
authors: K
authors: Øyri
authors: Bjørn
authors: B
authors: Edwin
mesh_terms: D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000191:economics / Q000401:mortality / Q000473:pathology*; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D017048:Health Care Costs; D006498:Hepatectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods* / Q000401:mortality; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000379:methods* / Q000401:mortality; D008113:Liver Neoplasms / Q000191:economics / Q000401:mortality / Q000556:secondary* / Q000601:surgery*; D059146:Metastasectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods* / Q000401:mortality; D009364:Neoplasm Recurrence, Local; D018365:Neoplasm, Residual; D009664:Norway; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome