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NCT02409979 · ClinicalTrials.gov registry record · NA
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
A NA study, sponsored by Presidio Ospedaliero Santa Barbara.
- Completed
- Registry status
- NA
- Development phase
- 246
- Enrollment target
NCT02409979 is a NA study that has completed, run by Presidio Ospedaliero Santa Barbara. The registered enrollment target is 246 participants.
The verdict
NCT02409979, a NA study, has completed, sponsored by Presidio Ospedaliero Santa Barbara.
- COMPLETED
- Registry status
- NA
- Development phase
- 246 participants
- Enrollment target
Study Summary
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the
Interventions
- OTHER Carbon dioxide method
- OTHER Water Exchange-CO2
- OTHER Water Exchange-AI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02409979
The ClinicalTrials.gov registry entry for NCT02409979 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presidio Ospedaliero Santa Barbara, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carbon dioxide method is the first listed.
NCT02409979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02409979 about?
NCT02409979 is a clinical study titled "Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes". Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved on...
What is the current status of trial NCT02409979?
This trial is currently completed. It is a NA study. The enrollment target is 246 participants. The study started on 2015-04. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02409979?
The interventions under investigation include: Carbon dioxide method (OTHER), Water Exchange-CO2 (OTHER), Water Exchange-AI (OTHER).
Who is sponsoring clinical trial NCT02409979?
This trial is sponsored by Presidio Ospedaliero Santa Barbara, which has 5 total clinical trials registered on ClinicalTrials.gov.
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