Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial

Abstract

BackgroundProximal gastrectomy has gradually gained more attention due to its superiority in retaining the function of part of the stomach. The inevitable loss of the antireflux barrier and postoperative complications resulting from proximal gastrectomy can severely affect the quality of life. Continuous improvements in digestive tract reconstruction after proximal gastrectomy have yielded the development of a variety of methods with antireflux functions. Recently, our center attempted the left-open single-flap technique and initiated a multicenter, prospective, randomized controlled trial for patients undergoing proximal gastrectomy to reduce the difficulty of surgical anastomosis and the incidence of perioperative complications compared with the double-flap technique. These findings will provide more evidence-based medical research for the development of clinical guidelines.Methods/designThis study is a prospective, multicenter, randomized controlled clinical trial. We plan to recruit 250 patients who are eligible for proximal gastrectomy. After informed consent is obtained, patients will be randomly assigned to the trial group (left-open single-flap technique) and the control group (double-flap technique) in a 1:1 allocation ratio.DiscussionIncreasingly, clinical studies have focused on the improvement of reconstruction modalities after proximal gastrectomy. Among these methods, the double-flap technique is a clinically effective method. The purpose of this study is to establish a prospective randomized controlled trial to compare the efficacy of the left-open single-flap technique versus the double-flap technique after proximal gastrectomy, aiming to provide more evidence-based medical studies for digestive tract reconstruction in proximal gastrectomy.Clinical Trial RegistrationClinicalTrials.gov, identifier [NCT05418920].

Digestive tract reconstruction after laparoscopic proximal gastrectomy for Gastric cancer: A systematic review

“…Wang et al reported the short-term efficacy of laparoscopic PG and esophagogastrostomy with single-flap technology in seven patients, observing satisfactory short-term efficacy for laparoscopic PG with single-flap anastomosis [49]. Yang et al [50] proposed single-flap anastomosis on the basis of double-flap anastomosis, that is, a "⊐"-shaped single flap with an opening toward the small curved side was made on the front wall of the gastric stump, the entire layer of the front wall of the gastric stump was cut at the lower edge of the muscle flap transversely, mucosal-esophageal anastomosis of the anterior wall of the stomach was performed, and the single flap and anterior wall of the stomach were continuously sutured before the anastomosis. A multicenter, prospective, randomized controlled study with a target completion date of July 31, 2027 could provide better conclusions from the research results.…”