Antireflux Surgery Without Preoperative Esophageal Manometry

NCT07659080 | Not Yet Recruiting

• 1 other identifier: 062625
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

GERD; Hiatal Hernia; Heartburn; Paraesophageal Hernia; Gastroesophageal Reflux

Keywords

GERD; hiatal hernia; fundoplication; Gastroesophageal Reflux Disease; Paraesophageal Hernia

Outcome Measures

Primary Outcomes (1)

• Mellow-Pinkas dysphagia score at 12 months

  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.

  12 months postoperatively

Secondary Outcomes (10)

• Gastroesophageal Reflux Disease Health-Related Quality of Life score

  3, 6, and 12 months postoperatively

• Proton pump inhibitor use

  3, 6, and 12 months postoperatively

• Postoperative complications

  30 and 90 days postoperatively

• Repeat non-routine endoscopy

  3, 6, and 12 months postoperatively

• Postoperative manometry ordered

  3, 6, and 12 months postoperatively

Study Arms (2)

No Manometry Arm

EXPERIMENTAL

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.

Procedure: Preoperative workup without high-resolution esophageal manometry

Standard Manometry Arm

ACTIVE COMPARATOR

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.

Procedure: Standard preoperative workup with high-resolution esophageal manometry

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.

No Manometry Arm

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.

Standard Manometry Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Presence of at least one guideline-based indication for antireflux surgery:
• Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy
• PPI-dependent GERD with patient preference for surgical management
• Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study
• Symptomatic Type II/III paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids)
• 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
• Mellow-Pinkas dysphagia score = 0 at baseline (no overt dysphagia)
• Eckardt score \< 1 (achalasia screening)
• Ability to provide informed consent and comply with 12-month follow-up.

You may not qualify if:

• Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1)
• Prior esophageal or gastric surgery
• Known or clinically suspected achalasia or primary motility disorder
• Endoscopic stricture, mass, or luminal obstruction
• Giant paraesophageal hernia (Type IV, or Type III with \>50% of stomach herniated intrathoracically)
• Connective tissue disease with esophageal involvement (e.g., scleroderma/CREST)
• Active esophageal or gastric malignancy
• Pregnancy
• 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)
• Participation in another interventional trial within 30 days
• 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.

Sponsors & Collaborators

• McMaster University: lead
• The Cleveland Clinic: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

St Joseph's Healthcare, McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

Yung LEE

CONTACT

416-732-7306; yung.lee@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups in a 1:1 non-inferiority design. Participants are randomized to the no-manometry arm or the standard-workup (manometry) arm. The arms differ only in preoperative workup: the standard arm undergoes high-resolution esophageal manometry before surgery, while the no-manometry arm does not. All participants in both arms receive the identical standardized laparoscopic Toupet 270-degree partial fundoplication with hiatal hernia repair. The trial tests the value of the diagnostic test (manometry), not the operation, which is held constant across arms.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)