Antireflux Surgery Without Preoperative Esophageal Manometry

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
McMaster University
Study ID
NCT07659080
Status
Not Yet Recruiting

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Conditions

  • GERD
  • Gastroesophageal Reflux
  • Heartburn
  • Hiatal Hernia
  • Paraesophageal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative workup without high-resolution esophageal manometry — PROCEDURE
    Participants assigned to this intervention will not undergo routine high-resolution esophageal manometry before surgery. They will complete the remaining preoperative assessment, including EGD and imaging, with ambulatory pH testing performed only if clinically indicated at the discretion of the treating surgeon.
  • Standard preoperative workup with high-resolution esophageal manometry — PROCEDURE
    Participants assigned to this intervention will undergo a standard preoperative workup, including EGD, imaging, optional ambulatory pH testing at the treating surgeon's discretion, and high-resolution esophageal manometry before surgery. Participants will then proceed to standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair.

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: No Manometry Arm
    Participants undergo EGD and imaging, with optional ambulatory pH testing at the discretion of the treating surgeon. High-resolution esophageal manometry is omitted before surgery. Participants proceed to standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair.
  • Active Comparator: Standard Manometry Arm
    Participants undergo a standard preoperative workup, including EGD, imaging, optional ambulatory pH testing at the discretion of the treating surgeon, and high-resolution esophageal manometry before surgery. Participants proceed to standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair.

Primary Outcome Measure

Mellow-Pinkas dysphagia score at 12 months [ Time Frame: 12 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Salvador Navarrete, MD
[email protected]
216-444-2200
Salvador Navarrete, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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