Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia

BACKGROUND AND RATIONALE Gastroesophageal reflux disease (GERD) and hiatal hernia are among the most common indications for foregut surgery. Laparoscopic antireflux surgery is a durable option for patients who fail or cannot tolerate proton pump inhibitor therapy. The Toupet 270-degree posterior partial fundoplication has become the preferred wrap at high-volume centers because it provides reflux control comparable to the complete Nissen wrap while producing significantly less postoperative dysphagia, as demonstrated across randomized trials and network meta-analysis.

High-resolution esophageal manometry (HRM) has traditionally been performed as part of the routine preoperative workup before antireflux surgery. Its historical rationale was threefold: to exclude major motility disorders such as achalasia, to characterize lower esophageal sphincter function, and to detect ineffective esophageal motility in order to guide wrap selection toward a partial fundoplication. The 2023 multi-society consensus guideline on the treatment of GERD now recommends a partial fundoplication for patients with either normal or abnormal manometry findings, which establishes the partial wrap as standard of care regardless of the manometry result. When the operation is already standardized to a Toupet wrap, the principal justification for routine manometry, namely wrap selection, is removed.

Manometry is not without burden. It requires transnasal catheter placement and esophageal intubation, is frequently reported as uncomfortable, adds scheduling delays of several weeks in publicly funded systems, and carries a direct cost of approximately 500 to 1,500 US dollars per patient. In patients without overt dysphagia, the prevalence of clinically unsuspected major motility disorders is consistently estimated at less than 2 to 5 percent. Despite this, whether manometry can be safely omitted in this carefully selected population has never been evaluated in a prospective randomized trial. This trial addresses that evidence gap.

OBJECTIVES AND HYPOTHESIS The primary objective is to determine whether upfront laparoscopic Toupet 270-degree fundoplication without preoperative manometry is non-inferior to standard manometry-guided care with respect to patient-reported dysphagia at 12 months. The investigators hypothesize that omitting manometry is non-inferior to standard care, because the operation is identical in both arms and patients most likely to harbor an unsuspected motility disorder are excluded at screening. Secondary objectives are to compare reflux-related quality of life, proton pump inhibitor use, 30- and 90-day complications, patient-reported procedural discomfort and anxiety, time from referral to surgery, and direct cost, and to quantify how often manometry findings would have altered operative management.

STUDY DESIGN AND SETTING This is a prospective, multicenter, open-label, randomized controlled non-inferiority trial conducted at St. Joseph's Healthcare Hamilton (McMaster University) and Cleveland Clinic. Both sites are high-volume foregut centers with dedicated esophageal motility laboratories, which supports recruitment and the safe management of any participant who requires manometry during the trial.