CO2 Insufflation During Double Balloon Enteroscopy

This study has been completed.
Sponsor:
Collaborator:
University Hospital Muenster
Information provided by:
Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00464022
First received: April 18, 2007
Last updated: October 16, 2007
Last verified: October 2007
  Purpose

Double-balloon enteroscopy (DBE) is a novel endoscopic procedure for visualising the entire small bowel. In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel to secure good visualisation. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, air is used for this purpose in more than 90% of centres throughout the world. The use of air, however, is far from ideal to use for insufflation in GI endoscopy. After GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected (5). This air has to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and discomfort during and after the examination due to the retention of air has been shown to be very common during and after endoscopic procedures (5-9).

Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several litres of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomised trials (6-9). In these studies, CO2 insufflation almost completely reduced procedure-related pain and discomfort.

To our knowledge, no research has been performed investigating the use of CO2 in DBE. DBE is a long-lasting procedure (mean examination time 75 minutes (4)). Large volumes of air are insufflated during the procedure, leading to significant distension of the small bowel during and after the examination.

One of the main technical difficulties in DBE is the formation of small bowel loops and scarp angels during deep intubation of the endoscope. These loops and angels are the major restriction to deep intubation of the endoscope. Loops and scarp angels are more pronounced in air-distended bowel segments.

The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in DBE patients. Furthermore, we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope and thus a more complete examination of the small bowel mucosa.

The study is designed as a two-centre randomised controlled trial. Randomisation to the two treatment groups (CO2 or air insufflation) is performed on basis of the individual participant.


Condition Intervention Phase
Pain
Device: Carbon dioxide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Carbon Dioxide Versus Air Insufflation in Double-Balloon Endoscopy -a Randomised Controlled Multicentre Trial

Resource links provided by NLM:


Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:
  • Abdominal pain and intubation depth

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for DBE

Exclusion Criteria:

  • Age under 16 years
  • Inability to understand information for participation
  • Refusal of participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464022

Locations
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Rikshospitalet University Hospital
University Hospital Muenster
Investigators
Principal Investigator: Michael Bretthauer Oslo University Hospital
  More Information

No publications provided by Rikshospitalet University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00464022     History of Changes
Other Study ID Numbers: 2006-3277
Study First Received: April 18, 2007
Last Updated: October 16, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Rikshospitalet University Hospital:
pain, endoscopy
Pain, endoscopy, randomised trial

ClinicalTrials.gov processed this record on August 28, 2014