Antireflux Surgery Without Preoperative Esophageal Manometry

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

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

Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy

PPI-dependent GERD with patient preference for surgical management

Disqualifiers

Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1)

Prior esophageal or gastric surgery

Known or clinically suspected achalasia or primary motility disorder

Endoscopic stricture, mass, or luminal obstruction

Trial design

Treatments tested in this trial

  • Preoperative workup without high-resolution esophageal manometry
  • Standard preoperative workup with high-resolution esophageal manometry

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

McMaster University

Lead sponsor

The Cleveland Clinic

Collaborator