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Antireflux Surgery Without Preoperative Esophageal Manometry

ConditionsGERDHiatal HerniaHeartburnParaesophageal HerniaGastroesophageal Reflux
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy

PPI-dependent GERD with patient preference for surgical management

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative workup without high-resolution esophageal manometry

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: No Manometry ArmExperimental treatment 1 intervention
Group B: Standard Manometry ArmActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 months postoperatively

Secondary outcomes

1

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.

Time frame
3, 6, and 12 months postoperatively
2

Proton pump inhibitor use

Use of proton pump inhibitor medication will be recorded, including whether the participant is using PPI therapy after surgery.

Time frame
3, 6, and 12 months postoperatively
3

Postoperative complications

Postoperative complications will be recorded and graded using the Clavien-Dindo classification.

Time frame
30 and 90 days postoperatively
4

Repeat non-routine endoscopy

The incidence of repeat non-routine endoscopy after surgery will be recorded.

Time frame
3, 6, and 12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: