Department of Gastrointestinal Surgery, Haraldsplass Deaconess Hospital, Bergen, Norway.
Department of Gastrointestinal Surgery, Haukeland University Hospital, Bergen, Norway.
BJS Open. 2023 Jul 10;7(4). doi: 10.1093/bjsopen/zrad074.
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.
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).
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).
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).
右半结肠癌的中央淋巴结清扫术沿肠系膜上轴进行，但由于缺乏共识以及对主要并发症的担忧，其范围仍存在争议。本随机对照试验比较了腹腔镜与开腹右半结肠切除术联合中央淋巴结清扫术治疗患者的术后发病率。
本研究为开放、前瞻性、随机对照试验，于 2016 年 10 月至 2021 年 12 月在挪威的两家机构比较了腹腔镜和开腹右半结肠切除术（c 期 I-III 期）联合中央淋巴结清扫术的患者。腹腔镜组沿肠系膜上静脉进行解剖，开腹组沿肠系膜上动脉的左前边界进行解剖，均遵循完整结肠系膜切除原则。两组手术均标准化，由三位经验丰富的外科医生进行。主要研究终点为术后 30 天并发症（Clavien-Dindo 分级≥2 级）发生率。
在 273 例符合条件的患者中，135 例被随机分配，128 例接受分析（开腹组 63 例，腹腔镜组 65 例）。开腹组患者术后并发症发生率为 42.8%，腹腔镜组为 38.4%，P=0.372。开腹组 Clavien-Dindo 3b 级并发症发生率为 7.9%，腹腔镜组为 4.6%，P=0.341。两组均无 4 级或 5 级并发症，也无因吻合口漏而再次手术。切除的淋巴结平均数（均数±标准误）无显著差异（开腹组与腹腔镜组分别为 31.9（1.8）枚和 29.3（1.3）枚；P=0.235）。
两组间并发症无显著差异。沿肠系膜根部行规范化右半结肠癌根治术联合中央淋巴结清扫术，无论采用腹腔镜还是开腹方式，主要并发症发生率为 4.6%至 7.9%，且无因吻合口漏而再次手术。两组淋巴结清扫的根治性相似。注册号：NCT03776591（http://www.clinicaltrials.gov）。
