Antireflux Surgery Without Preoperative Esophageal Manometry (NCT07659080) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Antireflux Surgery Without Preoperative Esophageal Manometry
United States, Canada96 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Presence of at least one guideline-based indication for antireflux surgery:
. Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy
. PPI-dependent GERD with patient preference for surgical management
. Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study
. Symptomatic Type II/III paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Objective documentation of pathologic esophageal acid exposure on ambulatory reflux monitoring (24-hour pH-impedance or 48-hour Bravo pH capsule) confirming GERD diagnosis, performed within 12 months of enrollment
Exclusion criteria
. 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
. Giant paraesophageal hernia (Type IV, or Type III with \>50% of stomach herniated intrathoracically)
. Connective tissue disease with esophageal involvement (e.g., scleroderma/CREST)