Antireflux Surgery Without Preoperative Esophageal Manometry

This study is looking into whether you can safely have surgery for acid reflux (GERD) or a hiatal hernia without first undergoing a test called esophageal manometry. Esophageal manometry uses a thin tube to measure the muscles in your food pipe, and it can be uncomfortable and delay surgery. Researchers want to see if skipping this test still leads to good swallowing one year after surgery, and if it reduces discomfort, shortens waiting times, and lowers costs. You might be able to join if you are at least 18 years old and have documented GERD or a hiatal hernia. The study will compare two groups: one that has surgery without manometry, and another that has manometry first, as is currently standard practice. The main goal is to check your swallowing ability 12 months after surgery.

Study design
This interventional study plans to enroll 96 participants to compare two different approaches to preparing for antireflux surgery.
What's involved
Participants will undergo either a standard preoperative workup including esophageal manometry, or a workup without this test, followed by antireflux surgery.
Compensation
Not stated in the trial record.
Follow-up
Your swallowing will be assessed 12 months after surgery.

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NCT07659080

Antireflux Surgery Without Preoperative Esophageal Manometry

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
McMaster University
~96 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Preoperative workup without high-resolution esophageal manometryStandard preoperative workup with high-resolution esophageal manometry

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mellow-Pinkas dysphagia score at 12 months
Measured over 12 months postoperatively
GERD
Hiatal Hernia
Heartburn
Paraesophageal Hernia
Gastroesophageal Reflux
2 sites across 2 states
Ohio1
Ontario1

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  • Mellow-Pinkas dysphagia score at 12 months12 months postoperatively

    Patient-reported dysphagia will be measured using the Mellow-Pinkas dysphagia scale. Scores range from 0 to 4, where 0 indicates no dysphagia and 4 indicates inability to swallow, including saliva. Higher scores indicate worse dysphagia.