CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 624 enrolled
Drug / intervention
Air Insufflation method. +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01954862
NCT01954862N/ACompleted

Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy: Air Insufflation, Carbon Dioxide and Water-aided Colonoscopy. A Randomized Controlled Trial.

Presidio Ospedaliero Santa Barbara·interventional·Posted Oct 7, 2013·Updated Jul 31, 2014

In Brief

A clinical study evaluating Air Insufflation method., CO2 insufflation, and 4 other interventions for Pain and 2 related conditions. Completed, enrolled 624 participants across 3 sites in 3 countries.

Detailed 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 sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 7, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.7 years ago

Interventions

Air Insufflation method.other

Air Insufflation method.

CO2 insufflationother

CO2 insufflation.

Water Immersion/CO2other

Water Immersion during insertion, CO2 insufflation during withdrawal.

Water Exchange/CO2other

Water Exchange during insertion, CO2 insufflation during withdrawal.

Water Immersion/AIother

Water Immersion during insertion, AI insufflation during withdrawal.

Water Exchange/AIother

Water Exchange during insertion, AI insufflation during withdrawal.