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Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The incidence of gastric cancer in East Asia is much higher than the international average. Therefore, improving the prognosis of patients and establishing effective clinical pathways are important topics for the prevention and treatment of gastric cancer. At present, the enhanced recovery after surgery (ERAS) pathway is widely used in the field of gastric surgery. Many randomized controlled trial (RCT) studies have proven that the ERAS regimen can improve the short-term clinical outcomes of patients with gastric cancer. However, a prospective study on the effect of the ERAS pathway on the prognosis of patients with gastric cancer has not yet been reported. This trial aims to confirm whether the ERAS pathway can improve the disease-free survival and overall survival of patients undergoing laparoscopic-assisted radical resection for distal gastric cancer. METHODS/DESIGN:This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The perioperative period of the experimental group will be managed according to the ERAS pathway and that of the control group will be managed according to the traditional management mode. An estimated 400 patients will be enrolled. The main endpoint for comparison is the 3-year overall survival and disease-free survival between the two groups. DISCUSSION:The results of this RCT should clarify whether the ERAS pathway is superior to traditional treatment on inflammatory indexes, short-term clinical outcome and survival for laparoscopic-assisted radical resection of distal gastric cancer. It is hoped that our data will provide evidence that the ERAS pathway improves survival in patients with gastric cancer. TRIAL REGISTRATION:Chinese Clinical Trial Registry, CHiCTR1900022438. Registered on 11 April 2019.

SUBMITTER: Tian Y

PROVIDER: S-EPMC7193340 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial.

Tian Yulong Y Cao Shougen S Li Leping L He Qingsi Q Xia Lijian L Jiang Lixin L Ding Yinlu Y Wang Xinjian X Wang Hao H Mao Weizheng W Hui Xizeng X Shi Yiran Y Zhang Huanhu H Chu Xianqun X Kehlet Henrik H Zhou Yanbing Y

Trials 20200501 1

<h4>Background</h4>The incidence of gastric cancer in East Asia is much higher than the international average. Therefore, improving the prognosis of patients and establishing effective clinical pathways are important topics for the prevention and treatment of gastric cancer. At present, the enhanced recovery after surgery (ERAS) pathway is widely used in the field of gastric surgery. Many randomized controlled trial (RCT) studies have proven that the ERAS regimen can improve the short-term clini ...[more]

PMID: 32357913

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Project description:Use of robotic surgery has increased in urological practice over the last decade. However, the use, outcomes, and costs of robotic nephrectomy are unknown.To examine the trend in use of robotic-assisted operations for radical nephrectomy in the United States and to compare the perioperative outcomes and costs with laparoscopic radical nephrectomy.This retrospective cohort study used the Premier Healthcare database to evaluate outcomes of patients who had undergone robotic-assisted or laparoscopic radical nephrectomy for renal mass at 416 US hospitals between January 2003 and September 2015. Multivariable regression modeling was used to assess outcomes.Robotic-assisted vs laparoscopic radical nephrectomy.The primary outcome of the study was the trend in use of robotic-assisted radical nephrectomy. The secondary outcomes were perioperative complications, based on the Clavien classification system, and defined as any complication (Clavien grades 1-5) or major complications (Clavien grades 3-5, for which grade 5 results in death); resource use (operating time, blood transfusion, length of hospital stay); and direct hospital cost.Among 23?753 patients included in the study (mean age, 61.4 years; men, 13?792 [58.1%]), 18?573 underwent laparoscopic radical nephrectomy and 5180 underwent robotic-assisted radical nephrectomy. Use of robotic-assisted surgery increased from 1.5% (39 of 2676 radical nephrectomy procedures in 2003) to 27.0% (862 of 3194 radical nephrectomy procedures) in 2015 (P for trend <.001). In the weighted-adjusted analysis, there were no significant differences between robotic-assisted and laparoscopic radical nephrectomy in the incidence of any (Clavien grades 1-5) postoperative complications (adjusted rates, 22.2% vs 23.4%, difference, -1.2%; 95% CI, -5.4 to 3.0%) or major (Clavien grades 3-5) complications (adjusted rates, 3.5% vs 3.8%, difference, -0.3%; 95% CI, -1.0% to 0.5%). The rate of prolonged operating time (>4 hours) for patients undergoing the robotic-assisted procedure was higher than for patients receiving the laparoscopic procedure in the adjusted analysis (46.3% vs 25.8%; risk difference, 20.5%; 95% CI, 14.2% to 26.8%). Robotic-assisted radical nephrectomy was associated with higher mean 90-day direct hospital costs ($19?530 vs $16?851; difference, $2678; 95% CI, $838 to $4519), mainly accounted for operating room ($7217 vs $5378; difference, $1839; 95% CI, $1050 to $2628) and supply costs ($4876 vs $3891; difference, $985; 95% CI, $473 to $1498).Among patients undergoing radical nephrectomy for renal mass between 2003 and 2015, the use of robotic-assisted surgery increased substantially. The use of robotic-assistance was not associated with increased risk of any or major complications but was associated with prolonged operating time and higher hospital costs compared with laparoscopic surgery.

Project description:BackgroundThe indication of retroperitoneal laparoscopic adrenalectomy (RLA) was extended with the retroperitoneal approach and has been wildly accepted and technologically matured. However, the management of large adrenal tumors via this approach still remains controversial. The aim of this study was to perform a comprehensive analysis on the minimally invasive surgical management of larger adrenal tumors.MethodsA total of 78 patients with large adrenal tumors (> 5 cm) and 97 patients with smaller adrenal tumors (< 5 cm) were enrolled in this study. The patient characteristics were preferentially analyzed. The intra-operative and postoperative indicators were compared between those who underwent RLA and those who underwent transperitoneal laparoscopic adrenalectomy (TLA); the intra-operative and postoperative indicators were also compared between the large tumor group and smaller tumor group of those who underwent RLA. Furthermore, the analyses of partial RLA were focused on the perioperative indicators and follow-up results.ResultsRLA was superior to TLA in terms of operation time (98.71 ± 32.30 min vs. 124.36 ± 34.62 min, respectively, P = 0.001), hospitalization duration (7.43 ± 2.82 days vs. 8.91 ± 3.40 days, respectively, P = 0.04), duration of drain (4.83 ± 0.37 days vs. 3.94 ± 2.21 days, respectively, P = 0.02), first oral intake (2.82 ± 0.71 days vs. 1.90 ± 0.83 days, respectively, P < 0.001) and time to ambulation (3.89 ± 1.64 days vs. 2.61 ± 1.42 days, respectively, P < 0.001). Further analyses of the RLA patients demonstrated that the larger tumor (> 5 cm) group showed superior results for the intraoperative indicators than the smaller tumor (< 5 cm) group (P < 0.05), while the results for the postoperative indicators between the two tumor size groups were similar (P > 0.05). Data confirmed that the partial resection method was superior to the total resection method from the perspective of the hormone supplement (0% vs. 48.15%, P = 0.002). The 2-year recurrence-free rates were 92.60 and 92.86% for the total and partial RLA resection methods, respectively (P = 0.97). The partial RLA resection method had a similar complete remission rate as the total RLA resection method (96.30% vs. 100%, respectively, P = 0.47).ConclusionBoth RLA and TLA seem to provide similar effects for the surgical management of large adrenal tumors. However, partial RLA resection should be considered for the management of benign tumors to reduce the hormone supplement.

Dataset Information

Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial.

Publications

Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial.

Similar Datasets

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