Antireflux Surgery for Acid Reflux

(NOMA Trial)

Not yet recruiting at 1 trial location
YL
Overseen ByYung LEE
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
Must be taking: PPIs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with acid reflux (GERD) or a hiatal hernia who do not have trouble swallowing before surgery. People with existing swallowing problems are not eligible.

Inclusion Criteria

Objective documentation of pathologic esophageal acid exposure on ambulatory reflux monitoring confirming GERD diagnosis within 12 months
I am 18 years old or older.
Eckardt score < 1 (achalasia screening)
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Exclusion Criteria

Participation in another interventional trial within 30 days
I have noticeable trouble swallowing.
Pregnancy
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo endoscopy and imaging, with optional ambulatory pH testing. High-resolution esophageal manometry is performed only in the standard-workup arm.

Up to 8 weeks
1-2 visits (in-person)

Surgery

Participants undergo standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments at 3, 6, and 12 months.

12 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two groups: one has antireflux surgery after the usual manometry test, and the other skips this test before surgery. Both groups get the same standard operation, and participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: No Manometry ArmExperimental Treatment1 Intervention
Group II: Standard Manometry ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+