ColonoscopyCACNCT00153647
A Study to Assess Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy
A study testing Cap-assisted colonoscopy in people with Colonoscopy and Lower Gastrointestinal Tract, run by Chinese University of Hong Kong at 2 sites in China.
Trial summary
The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the… 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-assisted colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- May 2005to Nov 2006
- 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 their first colonoscopy examination
Who cannot join
- Patients had received colonoscopy examination before
- Patients had prior colorectal surgery done (apart from appendectomy)
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Endoscopy Center, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)
The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.
Read the detailed description
Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.
- Conditions
- Colonoscopy, Lower Gastrointestinal Tract
- Being tested
- Cap-assisted colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap-assisted colonoscopyProcedure or surgery
Cap-assisted colonoscopy
Cap-assisted colonoscopyProcedure or surgery
Cap-assisted colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cap-assisted Colonoscopy Receives: Procedure: Cap-assisted colonoscopy |
| 2 | Placebo comparator | Regular Colonoscopy Receives: Procedure: Cap-assisted 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 (8)
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 procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale
Measured: 24 hours
The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale
Measured: 24 hours
The patient's pain score as assessed by the patient using a visual analog scale right after he regains full consciousness, which is assessed by accurately performing a deduction test (100 minus 7 test, correct for three deductions), before discharge
Measured: 24 hours
The dose of the intravenous drugs used
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 posted12 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Y T Lee, MD, Principal investigator, Department of Medicine & Therapeutics, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153647
- Sponsor's protocol ID
- CAC Study
- Acronym
- CAC
- Status last verified
- Aug 2007
- First submitted
- 8 Sep 2005
- Last updated
- 18 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)
- ClinicalTrials.gov ID
- NCT00153647
- Acronym / sponsor ID
- CAC / CAC Study
- Conditions
- Colonoscopy, Lower Gastrointestinal Tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 12 Sep 2005 (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 primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.
Detailed description
Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Cap-assisted colonoscopyCap-assisted Colonoscopy |
| 2 | Placebo comparator | Procedure: Cap-assisted colonoscopyRegular 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 their first colonoscopy examination
Key exclusion criteria (4 listed)
- Patients had received colonoscopy examination before
- Patients had prior colorectal surgery done (apart from appendectomy)
- 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
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-assisted colonoscopyCap-assisted colonoscopy | Procedure or surgery | 1 |
| Cap-assisted colonoscopyCap-assisted colonoscopy | Procedure or surgery | 2 |
Primary outcome
The success rate of cecal intubation
Time frame: 24 hours
8 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 procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale
Time frame: 24 hours
The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale
Time frame: 24 hours
The patient's pain score as assessed by the patient using a visual analog scale right after he regains full consciousness, which is assessed by accurately performing a deduction test (100 minus 7 test, correct for three deductions), before discharge
Time frame: 24 hours
The dose of the intravenous drugs used
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 18 Mar 2008.
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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.
Y T Lee, MD principal investigator
Department of Medicine & Therapeutics, Prince of Wales Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cap-assisted colonoscopy in people with Colonoscopy and Lower Gastrointestinal Tract, run by Chinese University of Hong Kong at 2 sites in China.
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 4 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 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
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 18 Mar 2008.