Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AdventHealth
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Pain measurement outcomes post procedure: Numeric Pain Scale
Study Overview
Brief Summary
Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater).
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications.
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials
Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.
Aim 2. Compare the proportion of patients that require post-procedural admission for pain management.
Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM.
Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.
Aim 5. Compare and evaluate procedural characteristics between the two groups.
- Compare procedural time between U-POEM and CO2-POEM.
- Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels.
- Adverse event rate (i.e. bleeding, perforation).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
Intervention: CO2-POEM (Procedure)
U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
Intervention: U-POEM (Procedure)
Outcomes
Primary Outcomes
Pain measurement outcomes post procedure: Numeric Pain Scale
Time Frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Using Numeric Pain Scale (NPS) NPS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Pain measurement outcomes post procedure: Pain Quality Assessment Scale
Time Frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Pain Quality Assessment Scale (PQAS). PQAS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Secondary Outcomes
- Compare technical success between POEM procedures(up to 6 months)
- Readmission rate(30 days post procedure (+- 7 days))
- Analgesic medication needs(30 days post procedure (+- 7 days))