Comparing two methods of pain management after esophageal surgery
Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)
This study is testing whether using underwater or carbon dioxide methods during esophageal surgery can help patients feel less pain and need less medication afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06918730 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial evaluates the post-procedural pain intensity experienced by patients undergoing Per-Oral Endoscopic Myotomy (POEM) using two different insufflation methods: underwater (U-POEM) and carbon dioxide (CO2-POEM). The study aims to determine which method results in less pain, fewer admissions for pain management, and reduced need for analgesic medications. By comparing these two approaches, the trial seeks to enhance patient satisfaction and safety during esophageal motility disorder treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for a POEM procedure due to esophageal dysmotility.
Not a fit: Patients with contraindications to POEM or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing esophageal surgery.
How similar studies have performed: Previous studies have shown promising results with underwater insufflation in other gastrointestinal procedures, suggesting potential benefits in this context as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Ability to provide informed consent * Patient scheduled to undergo POEM procedure for esophageal dysmotility Exclusion Criteria: * Inability to provide informed consent * Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy). * Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Where this trial is running
Orlando, Florida
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Yang, MD — AdventHealth Medical Group
- Study coordinator: Petronio T Senior Clinical Research Operations Manager, MHA
- Email: Petronio.martins@adventhealth.com
- Phone: 407-303-5503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.