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

Inje University

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Other: bowel insufflation gas

Study type: Interventional

Funder types: Other

Identifiers

NCT01450202

Oct 2011-01

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

Air insufflation, colonoscopy, esophagogastroduodenoscopy

Placebo Comparator group

Treatment:

Other: bowel insufflation gas

Other: bowel insufflation gas

CO2 insufflation, colonoscopy, esophagogastroduodenoscopy

Active Comparator group

Treatment:

Other: bowel insufflation gas

Other: bowel insufflation gas