Åsmund Avdem Fretland1,2,3, Vegar Johansen Dagenborg4,3,5, Gudrun Maria Waaler Bjørnelv1,6, Airazat M Kazaryan7, Ronny Kristiansen1,8, Morten Wang Fagerland9, John Hausken10, Tor Inge Tønnessen3,10, Andreas Abildgaard11, Leonid Barkhatov1,12,3, Sheraz Yaqub2, Bård I Røsok2, Bjørn Atle Bjørnbeth2, Marit Helen Andersen13,6, Kjersti Flatmark5,4,3, Eline Aas6, Bjørn Edwin1,2,3. 1. The Intervention Center, Oslo University Hospital, Oslo, Norway. 2. Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway. 3. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 4. Department of Tumor Biology, Oslo University Hospital, Oslo, Norway. 5. Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway. 6. Institute of Health and Society, University of Oslo, Oslo, Norway. 7. Department of Gastrointestinal Surgery, Akershus University Hospital, Lørenskog, Norway. 8. Department of Information Technology, Oslo University Hospital, Oslo, Norway. 9. Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway. 10. Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway. 11. Department of Radiology, Oslo University Hospital, Oslo, Norway. 12. Vestre Viken HF, Bærum Hospital, Bærum, Norway. 13. Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Abstract
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 undergoingparenchyma-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.
RCT Entities:
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.
Authors: Ioannis A Ziogas; Alexandros P Evangeliou; Konstantinos S Mylonas; Dimitrios I Athanasiadis; Panagiotis Cherouveim; David A Geller; Richard D Schulick; Sophoclis P Alexopoulos; Georgios Tsoulfas Journal: Eur J Health Econ Date: 2021-03-19