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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: bowel insufflation gas
* Other: bowel insufflation gas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Air insufflation, colonoscopy, esophagogastroduodenoscopy<br> | Other: bowel insufflation gas<br>* air insufflation, during colonoscopy and esophagogastroduodenoscopy<br>|
| Active Comparator: CO2 insufflation, colonoscopy, esophagogastroduodenoscopy<br> | Other: bowel insufflation gas<br>* CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-procedural pain | The primary end point of the study was to assess post-procedural pain according to VAS scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal distention | abdominal distention using measurement of patient waist circumferences | 3 months | 
| ETCO2 | Measure ETCO2 using nasal cannula | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures