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NCT07659080 · ClinicalTrials.gov registry record · NA
Antireflux Surgery Without Preoperative Esophageal Manometry
A NA study, sponsored by McMaster University.
- Not yet
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT07659080: Clinical Trial NA study, sponsored by McMaster University.
NCT07659080 is a NA study that has not yet begun recruiting, run by McMaster University. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07659080, a NA study, has not yet begun recruiting, sponsored by McMaster University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Preoperative workup without high-resolution esophageal manometry
- PROCEDURE Standard preoperative workup with high-resolution esophageal manometry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2028-04-30 |
| Phase | NA |
What is known before NCT07659080 opens enrollment
NCT07659080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Preoperative workup without high-resolution esophageal manometry is the first listed.
NCT07659080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07659080 about?
NCT07659080 is a clinical study titled "Antireflux Surgery Without Preoperative Esophageal Manometry". 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 c...
What is the current status of trial NCT07659080?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 96 participants. The study started on 2026-10-01. Estimated completion is 2028-04-30.
What interventions are being tested in trial NCT07659080?
The interventions under investigation include: Preoperative workup without high-resolution esophageal manometry (PROCEDURE), Standard preoperative workup with high-resolution esophageal manometry (PROCEDURE).
Who is sponsoring clinical trial NCT07659080?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07659080's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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