Laparoscopic total left-sided surgical approach versus traditional bilateral surgical approach for treating hiatal hernia: a study protocol for a randomized controlled trial

作者：Zhi Zheng, Weitao Zhang, Chenglin Xin, Na Zeng, Mengyi Li, Xiaoye Liu, Jun Cai, Fandong Meng, Dong Liu, Jie Zhang, Jie Yin, Jun Zhang, Zhongtao Zhang · 发表于：Annals of Translational Medicine · 年份：2021 · DOI：10.21037/atm-20-8000 · 被引用次数：7 · 研究领域：Gastroesophageal reflux and treatments、Gastrointestinal motility and disorders、Esophageal and GI Pathology

BACKGROUND: In China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH. METHODS: The current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients. Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index [consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information] and a safety evaluation index (consisting of the incidence of pos...