Clinical trial NCT01400087: Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lower Gastrointestinal Tract
Keywords: colonoscopy
Lower Gastrointestinal Tract
Cecal intubation
Cap-attached colonoscopy
Trainee
Lead sponsor: Showa University
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this prospective randomized controlled trial is to assess the efficacy of cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy for trainees.

Detailed description: Colorectal cancer is one of the major malignancies in western countries and also in Japan. Therefore , the demand for total colonoscopy (TCS) has risen remarkably. However, failure to reach the cecum occurs in up to 10 % of cases.

A difficult colonoscopy procedure will often be associated with more complications, and require heavier sedation to alleviate patient's discomfort.

Auxiliary devices that could facilitate the examination would be needed. A cap is a simple device that can be attached to the tip of a colonoscope. The advantage of the cap in getting a good view might be helpful in cecal intubation by depressing the folds and also by keeping an appropriate distance between the colonoscope lens and colonic mucosa. We speculated that inexperienced colonoscopists would obtain greater benefit from cap-attached colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo colonoscopy examination

Exclusion Criteria:

* Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
* Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding ・Patients who diagnosed as inflammatory bowel disease

Primary outcomes:
measure: The success rate of cecal intubation
timeFrame: 24 hours
Secondary outcomes:
measure: The procedure time to achieve cecal intubation
timeFrame: 24 hours
measure: Success rate in achieving terminal ileum intubation
timeFrame: 24 hours
measure: The procedure time to achieve terminal ileum intubation
timeFrame: 24 hours
measure: Complications related to the procedure
timeFrame: 24 hours
measure: The dose of the intravenous drugs used
timeFrame: 24 hours
measure: The polyp detection rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Digestive Disease Center, Showa University Northern Yokohama Hospital
state: Kanagawa
Study officials:
affiliation: Digestive Disease Center, Showa University Northern Yokohama Hospital
name: Shin-ei Kudo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.
citation: Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
citation: Harada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029.