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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.

ABSTRACT: 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.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).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.ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

SUBMITTER: Lu JY

PROVIDER: S-EPMC5146822 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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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.

Lu Jun-Yang JY Xu Lai L Xue Hua-Dan HD Zhou Wei-Xun WX Xu Tao T Qiu Hui-Zhong HZ Wu Bin B Lin Guo-Le GL Xiao Yi Y

Trials 20161208 1

<h4>Background</h4>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.<h4> ...[more]

PMID: 27931247

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Project description:BackgroundA 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.MethodsThis 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).ResultsOf 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).ConclusionThere 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).

Project description:BackgroundAlthough radical gastrectomy with D2 lymph node dissection has become the standard surgical approach for locally advanced gastric cancer, patients still have a poor prognosis after operation. Previously, we proposed laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision [D2 + CME]) as an optimized surgical procedure for locally advanced gastric cancer. By dissection along the boundary of the mesogastrium, D2 + CME resected proximal segments of the dorsal mesogastrium completely with less blood loss, and it improved the short-term surgical outcome. However, the oncologic therapeutic effect of D2 + CME has not yet been confirmed.Methods/designA single-center, prospective, parallel-group, randomized controlled trial of laparoscopic distal gastrectomy with D2 + CME versus conventional D2 was conducted for patients with locally advanced gastric cancer at Tongji Hospital, Wuhan, China. In total, 336 patients who met the following eligibly criteria were included and were randomized to receive either the D2 + CME or D2 procedure: (1) pathologically proven adenocarcinoma; (2) 18 to 75 years old; cT2-4, N0-3, M0 at preoperative evaluation; (3) expected curative resection via laparoscopic distal gastrectomy; (4) no history of other cancer, chemotherapy, or radiotherapy; (5) no history of upper abdominal operation; and (6) perioperative American Society of Anesthesiologists class I, II, or III. The primary endpoint is 3 years of disease-free survival. The secondary endpoints are overall survival, recurrence pattern, mortality, morbidity, postoperative recovery course, and other parameters.DiscussionPrevious studies have demonstrated the safety and feasibility of D2 + CME for locally advanced gastric cancer; however, there is still a lack of evidence to support its therapeutic effect. Thus, we performed this randomized trial to investigate whether D2 + CME can improve oncologic outcomes of patients with locally advanced gastric cancer. The findings from this trial may potentially optimize the surgical procedure and may improve the prognosis of patients with locally advanced gastric cancer.Trial registrationClinicalTrials.gov, NCT01978444 . Registered on October 31, 2013.

Project description:ObjectiveDuring the past decade, the concept of complete mesocolic excision (CME) has been developed in an attempt to minimize recurrence for right-sided colon cancer. This study aims to compare outcomes of robotic versus laparoscopic right hemicolectomy with CME for right-sided colon cancer.MethodsWe performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME. Data of all patients were retrospectively collected and reviewed. Of these, 149 cases were performed by a robotic approach, while the other 233 cases were done by laparoscopy. Propensity score matching was applied at a ratio of 1:1 to compare perioperative, pathologic, and oncologic outcomes between the robotic and the laparoscopic groups (n = 142).ResultsBefore propensity score matching, there were no statistical differences regarding the sex, history of abdominal surgery, body mass index (BMI), American Joint Committee on Cancer (AJCC) staging system, tumor location, and center between groups (p > 0.05), while a significant difference was observed regarding age (p = 0.029). After matching, two comparable groups of 142 cases were obtained with equivalent patient characteristics (p > 0.05). Blood loss, time to oral intake, return of bowel function, length of stay, and complications were not different between groups (p > 0.05). The robotic group showed a significantly lower conversion rate (0% vs. 4.2%, p = 0.03), but a longer operative time (200.9 min vs. 182.3 min, p < 0.001) and a higher total hospital cost (85,016 RMB vs. 58,266 RMB, p < 0.001) compared with the laparoscopic group. The number of harvested lymph nodes was comparable (20.4 vs. 20.5, p = 0.861). Incidence of complications, mortality, and pathologic outcomes were similar between groups (p > 0.05). The 2-year disease-free survival rates were 84.9% and 87.1% (p = 0.679), and the overall survival rates between groups were 83.8% and 80.7% (p = 0.943).ConclusionDespite the limitations of a retrospective analysis, the outcomes of robotic right hemicolectomy with CME were comparable to the laparoscopic procedures with fewer conversions to open surgery. More clinical advantages of the robotic surgery system need to be further confirmed by well-conducted randomized clinical trials with large cohorts of patients.

Project description:BackgroundThe complete mesogastrium excision (CME) based on D2 radical gastrectomy is believed to significantly reduce the local-regional recurrence compared with D2 radical gastrectomy in advanced gastric cancer, and it is widely used in China. This study aimed to explore whether D2 + CME is superior to D2 on surgical outcomes during gastrectomy from Chinese data.MethodsFeasible studies comparing the D2 + CME (D2 + CME group) and D2 (D2 group) published up to March 2020 are searched from electronic databases. The data showing surgical and complication outcomes are extracted to be pooled and analyzed.ResultsFourteen records including 1352 patients were included. The D2 + CME group had a shorter mean operative time (weighted mean difference [WMD] = -16.72 min, 95% confidence interval [CI]: -26.56 to -6.87 min, P < 0.001), lower mean blood loss (WMD = -39.08 mL, 95% CI: -49.94 to -28.21 mL, P < 0.001), higher mean number of retrieved lymph nodes (WMD = 2.13, 95% CI: 0.58-3.67, P = 0.007), shorter time to first flatus (WMD = -0.31 d, 95% CI: -0.53 to - 0.10 d, P = 0.005), and postoperative hospital days (WMD = -1.09, 95% CI: -1.92 to -0.25, P = 0.010) than the D2 group. Subgroup analysis suggested that the advantages from the D2 + CME group were obvious in traditional open radical gastrectomy, proximal gastrectomy, and distal gastrectomy compared with D2 group. The evaluations of post-operative complications showed that the patients who underwent D2 + CME had a lower incidence of post-operative complications than the patients who underwent D2 surgery alone (relative risk [RR] = 0.65, 95% CI: 0.45-0.87, P = 0.003). The D2 radical gastrectomy plus CME improved 3-year overall survival (OS) (RR = 1.16, 95% CI: 1.02-1.32, P = 0.020) and lowered the local recurrence rate (RR = 0.51, 95% CI: 0.28-0.94, P = 0.030). The patients undergoing laparoscopic surgery or total gastrectomy had more significant advantages compared between D2 + CME and D2 groups in 3-year OS.ConclusionThe data from China show that D2 radical gastrectomy plus CME are reliable procedures and safety compared to D2 radical gastrectomy with faster recovery, lower risk, and better prognosis.

Dataset Information

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.

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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.

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