ColonoscopyNCT01400087
Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees
A study testing Cap-attached Colonoscopy Versus Regular Colonoscopy in people with Colonoscopy and Lower Gastrointestinal Tract, run by Showa University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Lower Gastrointestinal Tract
- What is being tested?
- Cap-attached Colonoscopy Versus Regular Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo colonoscopy examination
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Japan1 site
Digestive Disease Center, Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
About this study
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.
Read the 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.
- Conditions
- Colonoscopy, Lower Gastrointestinal Tract
- Being tested
- Cap-attached Colonoscopy Versus Regular Colonoscopy
- Keywords
- colonoscopy, Lower Gastrointestinal Tract, Cecal intubation, Cap-attached colonoscopy, Trainee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap-attached Colonoscopy Versus Regular ColonoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cap-attached Colonoscopy | Active comparator | Not described Receives: Device: Cap-attached Colonoscopy Versus Regular Colonoscopy |
| Regular colonoscopy | Placebo comparator | Not described Receives: Device: Cap-attached Colonoscopy Versus Regular Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of cecal intubation
Measured: 24 hours
Secondary outcomes (6)
The procedure time to achieve cecal intubation
Measured: 24 hours
Success rate in achieving terminal ileum intubation
Measured: 24 hours
The procedure time to achieve terminal ileum intubation
Measured: 24 hours
Complications related to the procedure
Measured: 24 hours
The dose of the intravenous drugs used
Measured: 24 hours
The polyp detection rate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Kutsukawa, Showa University
- Investigators
- Shin-ei Kudo, Principal investigator, Digestive Disease Center, Showa University Northern Yokohama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400087
- Sponsor's protocol ID
- CAPSTUDY
- Status last verified
- Sep 2021
- First submitted
- 21 Jul 2011
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17100978Lee 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.
PubMed 19098847Harada 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.
PubMed 19251004
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees
- ClinicalTrials.gov ID
- NCT01400087
- Acronym / sponsor ID
- CAPSTUDY
- Conditions
- Colonoscopy, Lower Gastrointestinal Tract
- Keywords
- colonoscopy, Lower Gastrointestinal Tract, Cecal intubation, Cap-attached colonoscopy, Trainee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap-attached Colonoscopy | Active comparator | Device: Cap-attached Colonoscopy Versus Regular Colonoscopy |
| Regular colonoscopy | Placebo comparator | Device: Cap-attached Colonoscopy Versus Regular Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo colonoscopy examination
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cap-attached Colonoscopy Versus Regular ColonoscopyTrainees 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. | Device | Cap-attached Colonoscopy, Regular colonoscopy |
Primary outcome
The success rate of cecal intubation
Time frame: 24 hours
6 secondary outcomes
The procedure time to achieve cecal intubation
Time frame: 24 hours
Success rate in achieving terminal ileum intubation
Time frame: 24 hours
The procedure time to achieve terminal ileum intubation
Time frame: 24 hours
Complications related to the procedure
Time frame: 24 hours
The dose of the intravenous drugs used
Time frame: 24 hours
The polyp detection rate
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 17100978Kondo 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.
- Background: PubMed 19098847Lee 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.
- Background: PubMed 19251004Harada 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.
Related trials for Colonoscopy
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin-ei Kudo principal investigator
Digestive Disease Center, Showa University Northern Yokohama Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cap-attached Colonoscopy Versus Regular Colonoscopy in people with Colonoscopy and Lower Gastrointestinal Tract, run by Showa University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of cecal intubation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400087, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.