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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial

Authors: Xuyang Yang, Qingbin Wu, Chengwu Jin, Wanbin He, Meng Wang, Tinghan Yang, Mingtian Wei, Xiangbing Deng, Wenjian Meng, Ziqiang Wang

Published in: Trials | Issue 1/2017

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Abstract

Background

Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total “no-touch” isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total “no-touch” isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial.

Methods/design

This is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total “no-touch” isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery).

Discussion

This trial will provide valuable clinical evidence for the feasibility, safety, and potential total “no-touch” isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery.

Trial registration

ClinicalTrials.gov, NCT02625272. Registered on 8 December 2015.
Appendix
Available only for authorised users
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Metadata
Title
A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial
Authors
Xuyang Yang
Qingbin Wu
Chengwu Jin
Wanbin He
Meng Wang
Tinghan Yang
Mingtian Wei
Xiangbing Deng
Wenjian Meng
Ziqiang Wang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2084-3

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