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NCT07659080

Antireflux Surgery Without Preoperative Esophageal Manometry

Sponsor: McMaster University

View on ClinicalTrials.gov

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.

Official title: Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2028-04-30

Last Updated

2026-08-10

Healthy Volunteers

Conditions

GERD Hiatal Hernia Heartburn Paraesophageal Hernia Gastroesophageal Reflux

Interventions

PROCEDURE

Preoperative workup without high-resolution esophageal manometry

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.

PROCEDURE

Standard preoperative workup with high-resolution esophageal manometry

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.

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.

Locations (2)

Cleveland Clinic

Cleveland, Ohio, United States

St Joseph's Healthcare, McMaster University

Hamilton, Ontario, Canada