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Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Gastric cancer is the fourth most common malignant disease worldwide, with lower one-third gastric cancer the most common type. Distal gastrectomy with D2 lymph node dissection was recommended as a standard surgery for distal gastric cancer patients. However, some controversy remains about the anastomosis of the residual stomach and the intestine. The objectives of this trial are to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more effectively than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy. METHODS/DESIGN:This multi-center, prospective, phase III, randomized controlled trial will compare the efficacy of uncut Roux-en-Y anastomosis versus Billroth II anastomosis in phase I-III patients with initial treatment of radical distal gastrectomy. Patients will be randomized to undergo either the intervention (uncut Roux-en-Y anastomosis) or the control (Billroth II anastomosis). We will recruit 832 patients who meet the trial eligibility criteria and will follow the patients after surgery to observe postoperative complications and nutrition status for 5?years. The primary assessment indices of the study are reflux gastritis, esophagitis, bile regurgitation, and anastomotic ulcer. The secondary assessment indices are nutritional status, quality of life, perioperative complications, overall survival rate, and others. When the number of cases reaches 400, an interim analysis will be performed to identify any evidence of definite superiority of the experimental intervention. DISCUSSION:We aim to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy. The results of the trial will contribute to the best evidence on which to base the reconstruction of distal gastrectomy. TRIAL REGISTRATION:Chinese Southern Gastric Cancer Conference CSGC002 Trial. ClinicalTrials.gov, NCT02763878 . Registered on 5 May 2016.

SUBMITTER: Chen S

PROVIDER: S-EPMC6626339 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial.

Chen Shi S Chen Dong-Wen DW Chen Xi-Jie XJ Lin Yi-Jia YJ Xiang Jun J Peng Jun Sheng JS

Trials 20190712 1

<h4>Background</h4>Gastric cancer is the fourth most common malignant disease worldwide, with lower one-third gastric cancer the most common type. Distal gastrectomy with D2 lymph node dissection was recommended as a standard surgery for distal gastric cancer patients. However, some controversy remains about the anastomosis of the residual stomach and the intestine. The objectives of this trial are to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and ...[more]

PMID: 31300019

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Project description:BackgroundCurrently, there is no consensus on the most appropriate anastomotic site, anastomotic line, and direction for Billroth-II reconstruction with Braun anastomosis (B-II-B anastomosis) during totally laparoscopic distal gastrectomy (TLDG). Herein, we presented a novel anastomotic technique called R anastomosis for B-II-B anastomosis and compared it with the conventional B-II-B anastomosis technique to assess its feasibility, safety, and effectiveness.MethodsBetween March 2019 and September 2022 in our center, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Patients who underwent R anastomosis were matched in a 1:1 ratio with patients who underwent conventional anastomosis using a propensity score based on age, sex, preoperative body mass index (BMI), American Society of Anesthesiologists (ASA) score, and the history of abdominal surgery. Surgical and postoperative outcomes and clinicopathological data were analyzed for both groups.ResultsDuring the study period, 246 patients were included, 123 in each group. No intraoperative complications associated with digestive tract reconstruction and no cases of conversion to open surgery were reported in either group; furthermore, no incidences of perioperative mortality were noted in either group. The R group had a significantly reduced anastomotic time compared to the control group (30 ± 4.1 vs. 36 ± 5.3 min, P < 0.001). Perioperatively, the incidences of Clavien-Dindo grade II or higher complications were 6.5% (8/123) and 12.2% (15/123) in the R and control groups with no significant difference between the two groups. Postoperative gastric emptying dysfunction was found in five and one patient in the control and R groups, respectively.ConclusionR anastomosis is a safe and effective technique for B-II-B anastomosis following TLDG. This novel technique enhances the convenience of performing anastomosis and can reduce postoperative gastric emptying dysfunction.

Dataset Information

Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial.

Publications

Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial.

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