Clinical trial · Interventional
Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate
Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow patient recruitment, not enough patients willing to participate within the prespecified time frame.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomas | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fujinon EC-450BI5 double-balloon colonoscope | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DBC
- description
- Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments.
- interventionNames
- Procedure: Fujinon EC-450BI5 double-balloon colonoscope
Primary outcomes (1)
- measure
- Cecal intubation rate
- timeFrame
- 2 hours
- description
- 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 outcomes (1)
- measure
- Detection of additional colonic pathology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDRex 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. PMID 19240699
- BACKGROUNDNeerincx M, Terhaar sive Droste JS, Mulder CJ, Rakers 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. PMID 20669092
- BACKGROUNDYamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5. PMID 16007388
- BACKGROUNDMoreels 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. PMID 19686405
- BACKGROUNDMonkemuller 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. doi: 10.1080/00365520600802785. No abstract available. PMID 17327949
- BACKGROUNDPasha 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. doi: 10.1016/j.gie.2006.08.046. Epub 2007 Feb 26. PMID 17324408
- BACKGROUNDKaltenbach 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. doi: 10.1016/j.dld.2006.08.003. Epub 2006 Sep 20.