Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

NCT01400087 | Completed

• 1 other identifier: CAPSTUDY
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Lower Gastrointestinal Tract

Keywords

colonoscopy; Lower Gastrointestinal Tract; Cecal intubation; Cap-attached colonoscopy; Trainee

Outcome Measures

Primary Outcomes (1)

• The success rate of cecal intubation

  24 hours

Secondary Outcomes (6)

• The procedure time to achieve cecal intubation

  24 hours

• Success rate in achieving terminal ileum intubation

  24 hours

• The procedure time to achieve terminal ileum intubation

  24 hours

• Complications related to the procedure

  24 hours

• The dose of the intravenous drugs used

  24 hours

Study Arms (2)

Cap-attached Colonoscopy

ACTIVE COMPARATOR

Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Regular colonoscopy

PLACEBO COMPARATOR

Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Interventions

Cap-attached Colonoscopy Versus Regular Colonoscopy DEVICE

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.

Cap-attached Colonoscopy; Regular colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo colonoscopy examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Showa University: lead

Study Sites (1)

Digestive Disease Center, Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, 224-8503, Japan

Location

Related Publications (3)

• 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.

  PMID: 17100978 BACKGROUND

• 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.

  PMID: 19098847 BACKGROUND

• 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.

  PMID: 19251004 BACKGROUND

Study Officials

• Shin-ei Kudo

  Digestive Disease Center, Showa University Northern Yokohama Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 22, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

JP (1)