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…