Antireflux Surgery Without Preoperative Esophageal Manometry (NCT07659080)
Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
- Preoperative workup without high-resolution esophageal manometry (PROCEDURE)
- Standard preoperative workup with high-resolution esophageal manometry (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Cleveland Clinic — Cleveland, Ohio
- St Joseph's Healthcare, McMaster University — Hamilton, Ontario
📞 Contact the Study Coordinator
Phone: (416) 732-7306
Email: yung.lee@medportal.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in GERD
- Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair — Irvine, California
- Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy — Baltimore, Maryland
- PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients — Chicago, Illinois
- Mechanisms Preventing Pharyngeal Reflux — Milwaukee, Wisconsin
- Compassionate Use of Domperidone for Refractory Gastroparesis — Kansas City, Missouri
Explore by condition: All GERD clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.