Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia
McMaster University
Summary
The goal of this clinical trial is to learn if people can safely skip a test called esophageal manometry before surgery for acid reflux (gastroesophageal reflux disease, or GERD) or a hiatal hernia. Manometry measures the muscles of the food pipe using a thin tube passed through the nose. The test can be uncomfortable and can delay surgery. The main questions this study aims to answer are whether people can skip manometry and still have good swallowing one year after surgery, and whether skipping the test lowers discomfort, shortens the wait for surgery, and lowers cost. To answer this, researchers will compare two groups. One group will have surgery without manometry. The other group will have manometry first, the way it is usually done. Everyone will get the same operation, a partial wrap called a Toupet fundoplication, so the study tests the value of the test and not the surgery. Participants will be placed by chance into one of the two groups, have the same standard operation, and fill out short questionnaires about their swallowing before surgery and again at 3, 6, and 12 months after surgery. Researchers want to find out if skipping manometry works just as well as the usual approach for people who do not have trouble swallowing before surgery.
Description
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 esophage…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Age ≥ 18 years 2. Documented GERD and/or hiatal hernia (Type I, II, or small Type III) confirmed on EGD and/or imaging (i.e. CT scan or upper GI study) within 12 months 3. Presence of at least one guideline-based indication for antireflux surgery: 1. Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy 2. PPI-dependent GERD with patient preference for surgical management 3. Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study 4. Sympt…
Interventions
- ProcedurePreoperative workup without high-resolution esophageal manometry
Participants assigned to this intervention will not undergo routine high-resolution esophageal manometry before surgery. They will complete the remaining preoperative assessment, including EGD and imaging, with ambulatory pH testing performed only if clinically indicated at the discretion of the treating surgeon.
- ProcedureStandard preoperative workup with high-resolution esophageal manometry
Participants assigned to this intervention will undergo a standard preoperative workup, including EGD, imaging, optional ambulatory pH testing at the treating surgeon's discretion, and high-resolution esophageal manometry before surgery. Participants will then proceed to standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair.
Locations (2)
- Cleveland ClinicCleveland, Ohio
- St Joseph's Healthcare, McMaster UniversityHamilton, Ontario