ClinicalTrials.Veeva

Menu

Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

S

Showa University

Status

Completed

Conditions

Lower Gastrointestinal Tract
Colonoscopy

Treatments

Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01400087
CAPSTUDY

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

500 participants in 2 patient groups, including a placebo group

Cap-attached Colonoscopy
Active Comparator group
Treatment:
Device: Cap-attached Colonoscopy Versus Regular Colonoscopy
Regular colonoscopy
Placebo Comparator group
Treatment:
Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems