CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 246 enrolled
Drug / intervention
Carbon dioxide method +2 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/NCT02409979
NCT02409979N/ACompleted

Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial

Presidio Ospedaliero Santa Barbara·interventional·Posted Apr 7, 2015·Updated Nov 5, 2015

In Brief

A clinical study evaluating Carbon dioxide method, Water Exchange-CO2, and 1 other intervention for Abdominal Pain. Completed, enrolled 246 participants across 3 sites in 3 countries.

Detailed 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 post-procedure period.

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 7, 2015
Enrollment StartApr 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.2 years ago

Interventions

Carbon dioxide methodother

Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.

Water Exchange-CO2other

Insertion using water exchange, withdrawal using CO2 insufflation.

Water Exchange-AIother

Insertion using water exchange, withdrawal using air insufflation.