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Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients

Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01450202
Acronym
COCE
Enrollment
100
Registered
2011-10-12
Start date
2011-11-30
Completion date
2012-01-31
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures

Brief summary

Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy. The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.

Interventions

OTHERbowel insufflation gas

air insufflation, during colonoscopy and esophagogastroduodenoscopy

Sponsors

Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD

Exclusion criteria

* age \< 18 or \> 70 years * pregnancy * breast feeding * chronic obstructive lung disease (COPD) * known CO2 retention and refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
post-procedural pain3 monthsThe primary end point of the study was to assess post-procedural pain according to VAS scale

Secondary

MeasureTime frameDescription
abdominal distention3 monthsabdominal distention using measurement of patient waist circumferences
ETCO23 monthsMeasure ETCO2 using nasal cannula

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026