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NCT01954862 · ClinicalTrials.gov registry record · NA
Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy
A NA study, sponsored by Presidio Ospedaliero Santa Barbara.
- Completed
- Registry status
- NA
- Development phase
- 624
- Enrollment target
NCT01954862 is a NA study that has completed, run by Presidio Ospedaliero Santa Barbara. The registered enrollment target is 624 participants.
The verdict
NCT01954862, a NA study, has completed, sponsored by Presidio Ospedaliero Santa Barbara.
- COMPLETED
- Registry status
- NA
- Development phase
- 624 participants
- Enrollment target
Study Summary
Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum. WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen. In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed. Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure. Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI. In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sed
Interventions
- OTHER Air Insufflation method.
- OTHER CO2 insufflation
- OTHER Water Immersion/CO2
- OTHER Water Exchange/CO2
- OTHER Water Immersion/AI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01954862
The ClinicalTrials.gov registry entry for NCT01954862 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 624 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 5 interventions - of which Air Insufflation method. is the first listed.
NCT01954862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01954862 about?
NCT01954862 is a clinical study titled "Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy". Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following ...
What is the current status of trial NCT01954862?
This trial is currently completed. It is a NA study. The enrollment target is 624 participants. The study started on 2013-10. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01954862?
The interventions under investigation include: Air Insufflation method. (OTHER), CO2 insufflation (OTHER), Water Immersion/CO2 (OTHER), Water Exchange/CO2 (OTHER), Water Immersion/AI (OTHER).
Who is sponsoring clinical trial NCT01954862?
This trial is sponsored by Presidio Ospedaliero Santa Barbara, which has 5 total clinical trials registered on ClinicalTrials.gov.
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