Complications after open and laparoscopic right-sided colectomy with central lymphadenectomy for colon cancer: randomized controlled trial.

BACKGROUND: A central lymphadenectomy in right-sided colon cancer involves dissection along the superior mesenteric axis, but the extent is debated due to a lack of consensus and the fear of major complications. This randomized controlled trial compared the rate of postoperative morbidity in patients undergoing laparoscopic versus open right-sided colectomy with central lymphadenectomy. METHODS: This open, prospective, randomized controlled trial compared patients operated on with open and laparoscopic right-sided colectomy (cStages I-III) with a central lymphadenectomy at two Norwegian institutions between October 2016 and December 2021. Dissections were conducted along the superior mesenteric vein in the laparoscopic group, and along the left anterior border of the superior mesenteric artery in the open group, both according to complete mesocolic excision principles. Surgery was standardized and performed by three experienced surgeons for each study group. The primary outcome of interest was to measure postoperative 30-day complications (Clavien-Dindo ≥ grade II). RESULTS: Of 273 eligible patients, 135 were randomized and 128 analysed (63 operated on with open and 65 using laparoscopic procedures). Postoperative complications occurred in 42.8 per cent of the patients treated with open and 38.4 per cent of the patients treated using laparoscopic surgery, P = 0.372. The incidence of Clavien-Dindo grade IIIb complications was 7.9 per cent in the open versus 4.6 per cent in the laparoscopic group, P = 0.341. There were no grade IV or V complications, and no re-operations due to anastomotic leakages. There was no significant difference in the mean(s.e.m.) number of removed lymph nodes (open versus laparoscopic respectively: 31.9(1.8) versus 29.3(1.3); P = 0.235). CONCLUSION: There was no significant difference in complications between the two groups. Standardized oncologic right-sided colectomy with central lymphadenectomy along the mesenterial root was performed safely, both open and laparoscopic, with incidence of major complications ranging between 4.6 and 7.9 per cent and no re-operations for anastomotic leakage. Radicality in terms of lymphadenectomy was comparable between the two groups.Registration number: NCT03776591 (http://www.clinicaltrials.gov).