Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

NCT01587872 | Terminated

• 1 other identifier: SSK_DBC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Adenomas; Inflammatory Bowel Disease

Keywords

Colonoscopy; Colorectal cancer; Screening colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cecal intubation rate

  The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.

  2 hours

Secondary Outcomes (1)

• Detection of additional colonic pathology

  2 hours

Study Arms (1)

DBC

EXPERIMENTAL

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

Interventions

Fujinon EC-450BI5 double-balloon colonoscope PROCEDURE

Colonoscopy with the test instrument

DBC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failed cecal intubation during conventional colonoscopy due to technical difficulties

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Fujifilm Europa: collaborator

Study Sites (1)

Sorlandet Hospital HF

Kristiansand, 4604, Norway

Location

Related Publications (8)

• 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.

  PMID: 19240699 BACKGROUND

• Neerincx 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 BACKGROUND

• Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5.

  PMID: 16007388 BACKGROUND

• 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.

  PMID: 19686405 BACKGROUND

• Monkemuller 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 BACKGROUND

• 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. doi: 10.1016/j.gie.2006.08.046. Epub 2007 Feb 26.

  PMID: 17324408 BACKGROUND

• 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. doi: 10.1016/j.dld.2006.08.003. Epub 2006 Sep 20.

  PMID: 16990055 BACKGROUND

• 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. doi: 10.1055/s-2007-966753.

  PMID: 17703387 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Study Officials

• Michael Bretthauer, PhD

  The Cancer Registry of Norway, Oslo University Hospital

  STUDY CHAIR

• Kjetil K Garborg, MD

  Sorlandet Hospital HF, Kristiansand, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: April 30, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 14, 2014

Record last verified: 2012-04

Locations

NO (1)