Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate
Study Details
Study Description
Brief Summary
The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DBC Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments. |
Procedure: Fujinon EC-450BI5 double-balloon colonoscope
Colonoscopy with the test instrument
|
Outcome Measures
Primary Outcome Measures
- Cecal intubation rate [2 hours]
The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.
Secondary Outcome Measures
- Detection of additional colonic pathology [2 hours]
To assess if additional pathology is detected in segments of the colon reached with the test instrument that was not reached with a conventional colonoscope.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Failed cecal intubation during conventional colonoscopy due to technical difficulties
Exclusion Criteria:
-
Failed cecal intubation due to insufficient bowel preparation
-
Stenotic colonic lesions
-
Patients decline
-
Pregnancy
-
Persons younger than 18 years
-
Persons unable to comprehend the information given
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sorlandet Hospital HF | Kristiansand | Norway | 4604 |
Sponsors and Collaborators
- Sorlandet Hospital HF
- South-Eastern Norway Regional Health Authority
- Fujifilm Europa
Investigators
- Study Chair: Michael Bretthauer, PhD, The Cancer Registry of Norway, Oslo University Hospital
- Principal Investigator: Kjetil K Garborg, MD, Sorlandet Hospital HF, Kristiansand, Norway
Study Documents (Full-Text)
None provided.More Information
Publications
- Gay G, Delvaux M. Double-balloon colonoscopy after failed conventional colonoscopy: a pilot series with a new instrument. Endoscopy. 2007 Sep;39(9):788-92.
- Kaltenbach T, Soetikno R, Friedland S. Use of a double balloon enteroscope facilitates caecal intubation after incomplete colonoscopy with a standard colonoscope. Dig Liver Dis. 2006 Dec;38(12):921-5. Epub 2006 Sep 20.
- Mönkemüller K, Knippig C, Rickes S, Fry LC, Schulze A, Malfertheiner P. Usefulness of the double-balloon enteroscope in colonoscopies performed in patients with previously failed colonoscopy. Scand J Gastroenterol. 2007 Feb;42(2):277-8.
- Moreels TG, Macken EJ, Roth B, Van Outryve MJ, Pelckmans PA. Cecal intubation rate with the double-balloon endoscope after incomplete conventional colonoscopy: a study in 45 patients. J Gastroenterol Hepatol. 2010 Jan;25(1):80-3. doi: 10.1111/j.1440-1746.2009.05942.x. Epub 2009 Aug 3.
- Neerincx M, Terhaar sive Droste JS, Mulder CJ, Räkers M, Bartelsman JF, Loffeld RJ, Tuynman HA, Brohet RM, van der Hulst RW. Colonic work-up after incomplete colonoscopy: significant new findings during follow-up. Endoscopy. 2010 Sep;42(9):730-5. doi: 10.1055/s-0030-1255523. Epub 2010 Jul 28.
- Pasha SF, Harrison ME, Das A, Corrado CM, Arnell KN, Leighton JA. Utility of double-balloon colonoscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope. Gastrointest Endosc. 2007 May;65(6):848-53. Epub 2007 Feb 26.
- Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24. Erratum in: Am J Gastroenterol. 2009 Jun;104(6):1613.
- Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. Review.
- SSK_DBC