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Laparoscopic Versus Open Resection for Colorectal Liver Metastases

The OSLO-COMET Randomized Controlled Trial

Fretland, Åsmund Avdem MD*,†,‡; Dagenborg, Vegar Johansen MD§,‡,¶; Bjørnelv, Gudrun Maria Waaler MPhil*,†††; Kazaryan, Airazat M. MD, PhD**; Kristiansen, Ronny*,††; Fagerland, Morten Wang MSc, PhD‡‡; Hausken, John MD§§; Tønnessen, Tor Inge MD, PhD‡,§§; Abildgaard, Andreas MD, PhD¶¶; Barkhatov, Leonid MD*,||||,‡; Yaqub, Sheraz MD, PhD; Røsok, Bård I. MD, PhD; Bjørnbeth, Bjørn Atle MD, PhD; Andersen, Marit Helen RN, PhD***,†††; Flatmark, Kjersti MD, PhD¶,§,‡; Aas, Eline MPhil, PhD†††; Edwin, Bjørn MD, PhD*,†,‡

doi: 10.1097/SLA.0000000000002353
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Objective: To perform the first randomized controlled trial to compare laparoscopic and open liver resection.

Summary Background Data: Laparoscopic liver resection is increasingly used for the surgical treatment of liver tumors. However, high-level evidence to conclude that laparoscopic liver resection is superior to open liver resection is lacking.

Methods: Explanatory, assessor-blinded, single center, randomized superiority trial recruiting patients from Oslo University Hospital, Oslo, Norway from February 2012 to January 2016. A total of 280 patients with resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic (n = 133) or open (n = 147) parenchyma-sparing liver resection. The primary outcome was postoperative complications within 30 days (Accordion grade 2 or higher). Secondary outcomes included cost-effectiveness, postoperative hospital stay, blood loss, operation time, and resection margins.

Results: The postoperative complication rate was 19% in the laparoscopic-surgery group and 31% in the open-surgery group (12 percentage points difference [95% confidence interval 1.67–21.8; P = 0.021]). The postoperative hospital stay was shorter for laparoscopic surgery (53 vs 96 hours, P < 0.001), whereas there were no differences in blood loss, operation time, and resection margins. Mortality at 90 days did not differ significantly from the laparoscopic group (0 patients) to the open group (1 patient). In a 4-month perspective, the costs were equal, whereas patients in the laparoscopic-surgery group gained 0.011 quality-adjusted life years compared to patients in the open-surgery group (P = 0.001).

Conclusions: In patients undergoing parenchyma-sparing liver resection for colorectal metastases, laparoscopic surgery was associated with significantly less postoperative complications compared to open surgery. Laparoscopic resection was cost-effective compared to open resection with a 67% probability. The rate of free resection margins was the same in both groups. Our results support the continued implementation of laparoscopic liver resection.

*The Intervention Center, Oslo University Hospital, Oslo, Norway

Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway

Institute of Clinical Medicine, University of Oslo, Oslo, Norway

§Department of Tumor Biology, Oslo University Hospital, Oslo, Norway

Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway

**Department of Gastrointestinal Surgery, Akershus University Hospital, Lørenskog, Norway

††Department of Information Technology, Oslo University Hospital, Oslo, Norway

‡‡Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway

§§Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

¶¶Department of Radiology, Oslo University Hospital, Oslo, Norway

||||Vestre Viken HF, Bærum Hospital, Bærum, Norway

***Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway

†††Institute of Health and Society, University of Oslo, Oslo, Norway.

Reprints: Åsmund Avdem Fretland, MD, The Intervention Center, Oslo University Hospital, Pb. 4950 Nydalen, 0424 Oslo, Norway. E-mail: aasmund@fretland.no.

AAF, is a staff surgeon and researcher; VJD is a staff surgeon and researcher; GMWB is a health economist and researcher; AMK is a surgeon; RK is a researcher; MWF is the head of the Oslo Centre of Biostatistics and Epidemiology; JH is a staff anesthesiologist; TIT is a professor medicine and staff anesthesiologist; AA is chief of Abdominal Radiology at Oslo University Hospital; LB is a surgeon and researcher; SY is an attending HPB surgeon; BIR is an attending HPB surgeon; BAB is chief of HPB Surgery at the Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital; MHA is an associate professor and registered nurse; KF is a professor surgery and attending gastrointestinal surgeon; EA is an associate professor; and BE is professor of surgery and an attending HPB surgeon.

This work was supported by South-East Norway Health Authority, grants 201135 (Å.A.F.) and 201622 (G.M.W.B.), and the Research Council of Norway, grant 218325 (V.J.D.).

The authors, faculty, and staff in a position to control the content of this CME activity and their spouses/life partners (if any) have disclosed that they have no relationships with, or financial interests in, any commercial organizations pertaining to this educational activity.

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