Effect of laparoscopic W-H versus Nissen-Rossetti fundoplication for proton pump inhibitor dependent gastroesophageal reflux disease: A multicenter randomized controlled trial protocol

Our previous data showed that the W-H fundoplication had a similar mid-term satisfaction rate and a lower mid-term dysphagia rate with the Nissen-Rossetti fundoplication. But the results are limited by its retrospective nature. We plan to conduct a multicenter, randomized controlled trial to compare the 1-year dysphagia rate and efficacy after laparoscopic hiatal hernia repair combined with Nissen-Rossetti or W-H fundoplication for proton pump inhibitor dependent gastroesophageal reflux disease patients. The primary endpoint is dysphagia rate at 1-year after the surgery, the secondary endpoints are perioperative and other 1-year outcomes. Intention-to-treat analysis will be used for the study results. For the primary endpoint, the chi-square test or Fisher’s exact test will be used to compare the difference between the two groups, addressing whether the novel fundoplication technique can reduce the 1-year dysphagia rate. For categorical secondary endpoints, the chi-square test or Fisher’s exact test will be used to compare differences; for continuous secondary endpoints, the t-test or non-parametric tests will be used to compare differences. We have obtained ethical approval from all the three centers. Protocol changes will first be approved by the grant sponsor and communicated to the ethical boards and registry platform. Participating doctors will secure written informed consent from patients or surrogates. Anonymized data will be used in publications. Authors from the leading center will have access to the final dataset on the Resman platform. Data may be shared upon reasonable request. This study have registried in the Chinese Clinical Trial Registry (ChiCTR2400081762).