CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Carbon dioxide insufflation +3 moredevice
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/NCT02635217
NCT02635217N/ACompleted

Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?

Queen's University·interventional·Posted Dec 18, 2015·Updated May 9, 2018

In Brief

A clinical study evaluating Carbon dioxide insufflation, room air insufflation, and 2 other interventions for Anemia and Colon Polyps. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). An EGD is performed to examine the upper digestive tract to look for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube, stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining. During these procedures, room air is routinely used to insufflate (expand/inflate the stomach and the colon) to allow for better viewing of the lining of the upper and lower gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air) has been shown to possibly have less post-procedure patient discomfort. Additionally, when both procedures are performed in the same day, it is currently unknown as to which sequence of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa. The overall aim of our research is to compare patients' comfort, total amount of sedation used, and overall satisfaction with the procedures between four randomly allocated groups, to see which method of insufflation and which procedural sequence is better when both procedures need to be performed in the same day. We hypothesize that in patients requiring same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Colon Polyps
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 18, 2015
Enrollment StartJan 1, 2016
Primary CompletionNov 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.5 years ago

Interventions

Carbon dioxide insufflationdevice

using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies

room air insufflationdevice

using standard care room air will be infused on demand

EGD (Esophagogastroduodenoscopy) before Colonoscopyprocedure

the order of endoscopies will be randomized as well

Colonoscopy before EGD (Esophagogastroduodenoscopy)procedure