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Published on: March 24, 2023
Ligation site of the inferior mesenteric vein in laparoscopic radical resection of rectal cancer: a study protocol
Shidong Hu1, Songyan Li1, Yang Yan1
1Senior Department of General Surgery, The First Medical Center of Chinese PLA General Hospital, Beijing, P. R. China.
Background:
The optimal level of ligation of the inferior mesenteric vein (IMV) during rectal cancer surgery remains unclear. Lymph nodes are distributed at the root of the IMV, but whether root ligation and lymphadenectomy significantly increase the number of lymph nodes harvested or improve patient prognosis remains unclear. This multicenter randomized-controlled trial was designed to compare long-term survival and short-term outcomes (surgical complications, lymph node yield, postoperative recovery) between high and low IMV ligation during laparoscopic radical rectal cancer resection.
Methods:
This multicenter randomized-controlled trial will enroll 1,516 patients undergoing laparoscopic-assisted radical resection for rectal cancer. Participants will be recruited and randomized (1:1) by using a dynamic minimization algorithm to balance covariates, including age, sex, American Society of Anesthesiologists classification, tumor location, body mass index, preoperative clinical stage, and neoadjuvant therapy. Patients will be allocated to either high ligation or low ligation of the IMV. The primary endpoint is 3-year disease-free survival.
Discussion:
The IMV ligation level is a critical yet controversial step in radical rectal cancer resection. High-level evidence is lacking regarding whether high IMV ligation improves rectal cancer prognosis, necessitating robust evidence to determine the optimal ligation level.
Trial Registration:
ChiCTR, ChiCTR2300069149. Registered 8 March 2023, https://www.chictr.org.cn/showproj.html? proj=187562.
