Clinical trial NCT01587872: Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate
Official title: Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Adenomas
Inflammatory Bowel Disease
Keywords: Colonoscopy
Colorectal cancer
Screening colonoscopy
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Fujifilm Europa
First posted: 2012-04-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Cecal intubation rate
timeFrame: 2 hours
Secondary outcomes:
measure: Detection of additional colonic pathology
timeFrame: 2 hours
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
Study officials:
affiliation: The Cancer Registry of Norway, Oslo University Hospital
name: Michael Bretthauer, PhD
role: STUDY_CHAIR
affiliation: Sorlandet Hospital HF, Kristiansand, Norway
name: Kjetil K Garborg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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