Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759081
• Other study ID #: Hsieh-2016-01
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: April 29, 2016
• Start date: January 2015

Study information

• Verified date: April 2016
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria:

• obstructive lesions of the colon

• massive ascites

• history of partial colectomy

• provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cap-assisted Colonoscopy
• Colonoscopy
• Intubation Time

Intervention

Device:
• cap-assisted water exchange
a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.

Procedure:
• water exchange
water was infused and suctioned at the same time during insertion of colonoscope

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chia-Yi

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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

Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467. Review. — View Citation

Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cecal intubation time		when the colonoscope reaches the cecum, an average of 14 minutes	No
Secondary	Dose of propofol		The end of colonoscopy, an average of 14 minutes	No
Secondary	adenoma detection rate	when histology analysis of the removed polyps are available	One week after colonoscopy	No