CO2 Insufflation During Single-Balloon-Enteroscopy

Summary

Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel. In 2008, a novel balloon-assisted enteroscope system has been developed using only a single balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. The investigators could demonstrate the both endoscopic procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air, however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected. 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 have been shown to be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several liters 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 randomized trials. In these studies, CO2 insufflation had almost completely reduced procedure-related pain and discomfort.

In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no study has been performed investigating the use of CO2 in SBE.

The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.

Conditions

• Pain

Interventions

DEVICE

Single-Balloon-Enteroscopy with Air as insufflation gas.

Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.

DEVICE

Single-Balloon-Enteroscopy with CO2 as insufflation gas.

Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.

Sponsors & Collaborators

• Albert Schweitzer Hospital

  collaborator OTHER

• Nuovo Ospedale Civile S.Agostino Estense

  collaborator OTHER

• Azienda Ospedaliera San Giovanni Battista

  collaborator OTHER

• University Hospital Muenster

  lead OTHER

Principal Investigators

• Dirk Domagk, M.D., PhD · Department of Medicine B

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-02-28

Completion

2013-04-30

Countries

• Germany
• Italy

Study Locations