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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: Completed NA study, sponsored by Presidio Ospedaliero Santa Barbara.

NCT01954862 is a NA study that has completed, run by Presidio Ospedaliero Santa Barbara. The registered enrollment target is 624 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

Interventions

  • OTHER Air Insufflation method.
  • OTHER CO2 insufflation
  • OTHER Water Immersion/CO2
  • OTHER Water Exchange/CO2
  • OTHER Water Immersion/AI

Trial Details

FieldValue
Enrollment Target 624 participants
Start Date 2013-10
Est. Completion 2014-07
Phase NA

What the finished NCT01954862 record still lists

NCT01954862 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 5 interventions - of which Air Insufflation method. is the first listed.

NCT01954862 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01954862's enrollment target sits among peer trials

624 161st of 2000 higher than 1,840 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01954862, the US trial registry maintained by the National Library of Medicine. NCT01954862 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.