Antireflux Surgery Without Preoperative Esophageal Manometry (NOMA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroesophageal Reflux; Hiatal Hernia; GERD; Heartburn; Paraesophageal Hernia
• Intervention / Treatment: Procedure: Preoperative workup without high-resolution esophageal manometry; Procedure: Standard preoperative workup with high-resolution esophageal manometry

Detailed Description

BACKGROUND AND RATIONALE Gastroesophageal reflux disease (GERD) and hiatal hernia are among the most common indications for foregut surgery. Laparoscopic antireflux surgery is a durable option for patients who fail or cannot tolerate proton pump inhibitor therapy. The Toupet 270-degree posterior partial fundoplication has become the preferred wrap at high-volume centers because it provides reflux control comparable to the complete Nissen wrap while producing significantly less postoperative dysphagia, as demonstrated across randomized trials and network meta-analysis.

High-resolution esophageal manometry (HRM) has traditionally been performed as part of the routine preoperative workup before antireflux surgery. Its historical rationale was threefold: to exclude major motility disorders such as achalasia, to characterize lower esophageal sphincter function, and to detect ineffective esophageal motility in order to guide wrap selection toward a partial fundoplication. The 2023 multi-society consensus guideline on the treatment of GERD now recommends a partial fundoplication for patients with either normal or abnormal manometry findings, which establishes the partial wrap as standard of care regardless of the manometry result. When the operation is already standardized to a Toupet wrap, the principal justification for routine manometry, namely wrap selection, is removed.

Manometry is not without burden. It requires transnasal catheter placement and esophageal intubation, is frequently reported as uncomfortable, adds scheduling delays of several weeks in publicly funded systems, and carries a direct cost of approximately 500 to 1,500 US dollars per patient. In patients without overt dysphagia, the prevalence of clinically unsuspected major motility disorders is consistently estimated at less than 2 to 5 percent. Despite this, whether manometry can be safely omitted in this carefully selected population has never been evaluated in a prospective randomized trial. This trial addresses that evidence gap.

OBJECTIVES AND HYPOTHESIS The primary objective is to determine whether upfront laparoscopic Toupet 270-degree fundoplication without preoperative manometry is non-inferior to standard manometry-guided care with respect to patient-reported dysphagia at 12 months. The investigators hypothesize that omitting manometry is non-inferior to standard care, because the operation is identical in both arms and patients most likely to harbor an unsuspected motility disorder are excluded at screening. Secondary objectives are to compare reflux-related quality of life, proton pump inhibitor use, 30- and 90-day complications, patient-reported procedural discomfort and anxiety, time from referral to surgery, and direct cost, and to quantify how often manometry findings would have altered operative management.

STUDY DESIGN AND SETTING This is a prospective, multicenter, open-label, randomized controlled non-inferiority trial conducted at St. Joseph's Healthcare Hamilton (McMaster University) and Cleveland Clinic. Both sites are high-volume foregut centers with dedicated esophageal motility laboratories, which supports recruitment and the safe management of any participant who requires manometry during the trial.

RANDOMIZATION AND ALLOCATION CONCEALMENT Participants are randomized 1:1 through a central, web-based system with concealed allocation, using variable permuted blocks. Randomization is stratified by site, hernia type, and pH testing status. Because ambulatory pH testing is performed at the discretion of the treating surgeon and may influence outcomes independently, pH testing status is used as a stratification variable so that participants who undergo pH testing are balanced between arms, and those who do not are likewise balanced. This preserves internal validity and supports a prespecified subgroup analysis.

BLINDING Patients and surgeons cannot be blinded to allocation given the nature of the intervention. Outcome assessors and data analysts are blinded to allocation.

STUDY ARMS AND INTERVENTION Participants in the no-manometry arm undergo endoscopy and imaging (computed tomography or upper gastrointestinal study) without preoperative manometry, and proceed directly to surgery. Participants in the standard-workup arm undergo the same endoscopy and imaging plus high-resolution esophageal manometry within eight weeks before surgery. Ambulatory pH testing may be performed at the surgeon's discretion in either arm per institutional practice.

In both arms the operation is identical. All participants undergo a standardized laparoscopic Toupet 270-degree posterior partial fundoplication with hiatal hernia repair. The operative standard is defined by a technique manual and includes a five-port laparoscopic approach, complete circumferential gastroesophageal junction dissection, posterior cruroplasty with interrupted non-absorbable sutures, at least 2.5 centimeters of tension-free intra-abdominal esophageal length, and wrap construction sutured to the esophageal wall bilaterally. Intraoperative endoscopy is mandatory in all cases to confirm wrap calibration and adequacy. The operative approach does not vary with manometry findings; this standardization is the key design feature that removes the conventional justification for routine manometry.

CROSSOVER AND SAFETY Crossover from the no-manometry arm to manometry is permitted only for intraoperative findings highly suggestive of a primary motility disorder, such as failure of lower esophageal sphincter relaxation or a bird-beak appearance. In such cases the operation is aborted and manometry is arranged postoperatively. Both participating sites have dedicated motility laboratories capable of high-resolution manometry and ambulatory pH testing to manage any such participant. All crossovers are analyzed in the intention-to-treat population and documented as protocol deviations for the per-protocol analysis. This is a minimal-risk trial in which both arms receive standard-of-care surgery; safety is monitored by the investigators through systematic capture of surgical complications graded by the Clavien-Dindo classification.

SCHEDULE OF ASSESSMENTS Assessments are collected at screening, baseline, the preoperative visit, surgery, and at 3, 6, and 12 months after surgery. Patient-reported outcomes are administered at baseline and at each postoperative timepoint and are captured electronically in a secure, access-controlled REDCap database hosted through McMaster University, with paper backup. Surgical complications are recorded at 30 and 90 days.

SAMPLE SIZE The sample size is based on the primary outcome. Assuming an expected mean dysphagia score of 0.35 with a standard deviation of 0.80, a non-inferiority margin of 0.5 points, a two-sided alpha of 0.05, and 80 percent power, approximately 40 participants per arm are required. Allowing for a conservative 15 percent dropout, the enrollment target is 48 participants per arm, for a total of 96 participants.

STATISTICAL ANALYSIS Non-inferiority will be concluded if the upper bound of the two-sided 95 percent confidence interval for the between-arm difference in the primary outcome lies below the prespecified margin of 0.5 points, using a two-sample t-test or a Wilcoxon rank-sum test if the normality assumption is not met. The primary analysis is by intention to treat, with a per-protocol analysis performed as a sensitivity analysis. Secondary outcomes will be analyzed using mixed-effects models for repeated measures, Kaplan-Meier estimation with log-rank testing for time-to-event outcomes, and Fisher exact tests for proportions. Missing data will be handled using multiple imputation under a missing-at-random assumption. A prespecified subgroup analysis by pH testing status will be performed for the primary outcome.

DATA MANAGEMENT AND MONITORING Study data are recorded under a unique study identifier, with the linking key stored separately and securely and accessible only to the local study team. The trial is minimal risk and does not use a formal data safety monitoring board; the investigators review enrollment, protocol deviations, and adverse events during accrual, and report serious adverse events and unanticipated problems to the research ethics board within required timelines.

ETHICS AND REGISTRATION The trial holds ethics approval from the Hamilton Integrated Research Ethics Board and will be conducted in accordance with the Tri-Council Policy Statement, Good Clinical Practice, and applicable institutional and regulatory requirements at each site. The trial is registered on ClinicalTrials.gov before enrollment of the first participant.

SIGNIFICANCE This trial provides the first randomized evidence on whether preoperative manometry can be safely omitted before standardized partial fundoplication in patients without overt dysphagia. A finding of non-inferiority would support simplifying the preoperative pathway, shortening time to surgery, improving patient experience, and reducing cost, and could inform practice guidelines internationally. A neutral result would clarify the true clinical utility of manometry and support more selective rather than routine testing.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yung LEE; Phone Number: 416-732-7306; Email: yung.lee@medportal.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St Joseph's Healthcare, McMaster University
      • Contact: Yung Lee, MD MPH; Phone Number: 4167327306; Email: yung.lee@medportal.ca
      • Principal Investigator: Yung Lee, MD MPH
      • Sub-Investigator: Dennis Hong, MD MSc
• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
      • Contact: Salvador Navarrete, MD; Phone Number: 216-444-2200; Email: navarrs@ccf.org
      • Principal Investigator: Salvador Navarrete, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroesophageal Reflux Disease Health-Related Quality of Life score	Reflux-related quality of life will be measured using the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire. Total scores range from 0 to 45, with higher scores indicating worse reflux-related symptoms and quality of life.	3, 6, and 12 months postoperatively
Proton pump inhibitor use	Use of proton pump inhibitor medication will be recorded, including whether the participant is using PPI therapy after surgery.	3, 6, and 12 months postoperatively
Postoperative complications	Postoperative complications will be recorded and graded using the Clavien-Dindo classification.	30 and 90 days postoperatively
Repeat non-routine endoscopy	The incidence of repeat non-routine endoscopy after surgery will be recorded.	3, 6, and 12 months postoperatively
Postoperative manometry ordered	The incidence of postoperative manometry ordered after surgery will be recorded.	3, 6, and 12 months postoperatively
Procedural discomfort numeric rating scale score	Patient-reported discomfort related to preoperative testing will be measured using an 11-point numeric rating scale. Scores range from 0 to 10, where 0 indicates no discomfort and 10 indicates the worst discomfort imaginable. Higher scores indicate greater discomfort (manometry arm only).	Baseline and preoperative visit
Short-form State-Trait Anxiety Inventory 6-item anxiety score	Anxiety related to preoperative testing will be measured using the Short-form State-Trait Anxiety Inventory 6-item questionnaire. Raw scores range from 6 to 24 and may be scaled to 20 to 80, with higher scores indicating greater anxiety.	Baseline and preoperative visit
Referral-to-surgery interval	The number of days from surgical consultation or referral to the date of surgery will be recorded.	At surgery, up to 18 months after enrollment
Direct cost associated with manometry omission	Institution-level direct costs associated with high-resolution esophageal manometry will be compared between study arms.	Through study completion, an average of 18 months
DeMeester score at 12 months	DeMeester score will be recorded among participants with available ambulatory pH testing. Scores have a minimum value of 0 and no fixed maximum; higher scores indicate greater esophageal acid exposure.	12 months postoperatively

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: GERD; Gastroesophageal Reflux Disease; Paraesophageal Hernia; fundoplication; hiatal hernia
• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Hernia; Hernia, Diaphragmatic; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hernia, Hiatal; Gastroesophageal Reflux; Heartburn
• Other Study ID Numbers: 062625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not planned to be shared publicly at this time because the study involves patient-level clinical data and will be subject to institutional privacy, ethics, and data governance requirements. Any future data-sharing requests would require review and approval by the study investigators and applicable institutional review bodies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No