Unnecessary test? study questions routine throat tube before reflux surgery
NCT ID NCT07659080
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study looks at whether people with acid reflux or a hiatal hernia can safely skip a test called esophageal manometry before their surgery. The test, which involves a thin tube through the nose to measure throat muscles, can be uncomfortable and delay surgery. Researchers will compare two groups of 96 adults: one group gets the test as usual, the other skips it. Everyone will have the same standard operation. The goal is to see if skipping the test leads to similar swallowing ability one year after surgery, while reducing discomfort and wait times.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If skipping manometry works as well as the standard approach, it could make preparing for acid reflux surgery faster, less uncomfortable, and cheaper.
- What could go wrong
- This is a small, early-stage study (96 people) comparing two preoperative procedures, not testing a new treatment. Results may not apply to everyone with GERD.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Symptomatic Type II/III paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids) 5. 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 4. Mellow-Pinkas dysphagia score = 0 at baseline (no overt dysphagia) 5. Eckardt score \< 1 (achalasia screening) 6. Ability to provide informed consent and comply with 12-month follow-up. Exclusion Criteria: 1. Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1) 2. Prior esophageal or gastric surgery 3. Known or clinically suspected achalasia or primary motility disorder 4. Endoscopic stricture, mass, or luminal obstruction 5. Giant paraesophageal hernia (Type IV, or Type III with \>50% of stomach herniated intrathoracically) 6. Connective tissue disease with esophageal involvement (e.g., scleroderma/CREST) 7. Active esophageal or gastric malignancy 8. Pregnancy 9. BMI \> 40 kg/m² (patients with severe obesity who would be candidates for bariatric surgery should be referred for metabolic/bariatric evaluation, as per the multi-society GERD guideline recommending weight-loss surgery consideration in this population) 10. Participation in another interventional trial within 30 days 11. Prior esophageal manometry within 12 months demonstrating a major motility disorder (achalasia, absent contractility, distal esophageal spasm, hypercontractile esophagus); such patients should be managed per standard motility disorder pathways and are not candidates for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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St Joseph's Healthcare, McMaster University
Hamilton, Ontario, L8N 4A6, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heartburn drug under the microscope: registry tracks thousands of pregnancies
- Which acid blocker wins in obese reflux patients?
- Can banding the esophagus stop reflux? a small trial tests the idea
- Through-the-Mouth surgery vs keyhole surgery: which works better for a rare swallowing disorder?
- Can a Pre-Surgery checklist predict who will still have reflux after fundoplication?
- Can a less invasive reflux surgery match the standard one?