Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

Colonoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400087
• Other study ID #: CAPSTUDY
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2021
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Lower Gastrointestinal Tract

Intervention

Device:
• Cap-attached Colonoscopy Versus Regular Colonoscopy
Trainees were divided into two group; Cap-attached Colonoscopy group or Regular Colonoscopy group. Trainees allocated to the former group undergo colonoscopy with cap for all cases, the latter without cap.

Locations

Country	Name	City	State
Japan	Digestive Disease Center, Showa University Northern Yokohama Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Showa University

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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. — View 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. Epub 2006 Nov 13. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of cecal intubation		24 hours
Secondary	The procedure time to achieve cecal intubation		24 hours
Secondary	Success rate in achieving terminal ileum intubation		24 hours
Secondary	The procedure time to achieve terminal ileum intubation		24 hours
Secondary	Complications related to the procedure		24 hours
Secondary	The dose of the intravenous drugs used		24 hours
Secondary	The polyp detection rate		24 hours