CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 270 enrolled
Drug / intervention
air insufflation +2 moreprocedure
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/NCT01535326
NCT01535326N/ACompleted

Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Dalin Tzu Chi General Hospital·interventional·Posted Feb 17, 2012·Updated Aug 15, 2014

In Brief

A clinical study evaluating air insufflation, water immersion, and 1 other intervention for Colon Neoplasm and Pain. Completed, enrolled 270 participants across 1 site.

Detailed Summary

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange). This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Neoplasm, Pain
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.4 years ago

Interventions

air insufflationprocedure

insufflate air during the insertion of colonoscopy

water immersionprocedure

infuse water during insertion, aspirate water during withdrawal

water exchangeprocedure

infuse and remove water during insertion phase of colonoscopy