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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

The Radical Extent of lymphadenectomy — D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial

Authors: Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Yi Xiao

Published in: Trials | Issue 1/2016

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Abstract

Background

The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy.

Methods/design

The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes).

Discussion

The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety.

Trial registration

ClinicalTrials.gov: NCT02619942. Registered on 29 November 2015.
Appendix
Available only for authorised users
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Metadata
Title
The Radical Extent of lymphadenectomy — D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial
Authors
Jun-Yang Lu
Lai Xu
Hua-Dan Xue
Wei-Xun Zhou
Tao Xu
Hui-Zhong Qiu
Bin Wu
Guo-Le Lin
Yi Xiao
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1710-9

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