Colorectal CancerNCT00841282
RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees
A study testing Colonoscopy for colorectal cancer screening, Water Infusion Colonoscopy and Air insufflation colonoscopy in people with Colorectal Cancer, run by East Bay Institute for Research and Education at 1 site in United States.
Trial summary
Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy for colorectal cancer screening, Water Infusion Colonoscopy and Air insufflation colonoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2009
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,
- Accept randomization to the study or the conventional method, and agree to complete study questionnaires
- The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2
Who cannot join
- Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded
- Excluded patients will be managed by usual procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento VA Medical Center,
Mather, California, 95655
About this study
Official title: Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance
Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.
Read the detailed description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.
Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy for colorectal cancer screening, Water Infusion Colonoscopy, Air insufflation colonoscopy
- Keywords
- Colorectal cancer screening, Optical colonoscopy, Water method, Sedation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy for colorectal cancer screeningProcedure or surgery
Water Infusion ColonoscopyProcedure or surgery
water infusion in lieu of air insufflation for screening colonoscopy
Air insufflation colonoscopyProcedure or surgery
Conventional colonoscopy with air insufflation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Water Infusion in lieu of Air Insufflation Colonoscopy Receives: Procedure: Colonoscopy for colorectal cancer screening; Procedure: Water Infusion Colonoscopy |
| 2 | Placebo comparator | Air Insufflation Colonoscopy Receives: Procedure: Colonoscopy for colorectal cancer screening; Procedure: Air insufflation colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increments of medications used for sedation
Measured: duration of procedure
Secondary outcomes (3)
pain score during colonoscopy
Measured: duration of procedure
success of cecal intubation
Measured: duration of study
willingness to repeat colonoscopy
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Bay Institute for Research and Education
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841282
- Sponsor's protocol ID
- EBIRE-GI-002
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance
- ClinicalTrials.gov ID
- NCT00841282
- Acronym / sponsor ID
- EBIRE-GI-002
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, Optical colonoscopy, Water method, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- East Bay Institute for Research and EducationUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Feb 2009 (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.
Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.
Detailed description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.
Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Colonoscopy for colorectal cancer screening, Procedure: Water Infusion ColonoscopyWater Infusion in lieu of Air Insufflation Colonoscopy |
| 2 | Placebo comparator | Procedure: Colonoscopy for colorectal cancer screening, Procedure: Air insufflation colonoscopyAir Insufflation Colonoscopy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,
- Accept randomization to the study or the conventional method, and agree to complete study questionnaires
- The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2
Key exclusion criteria (2 listed)
- Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded
- Excluded patients will be managed by usual procedures
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 |
|---|---|---|
| Colonoscopy for colorectal cancer screening | Procedure or surgery | 1, 2 |
| Water Infusion Colonoscopywater infusion in lieu of air insufflation for screening colonoscopy | Procedure or surgery | 1 |
| Air insufflation colonoscopyConventional colonoscopy with air insufflation | Procedure or surgery | 2 |
Primary outcome
Increments of medications used for sedation
Time frame: duration of procedure
3 secondary outcomes
pain score during colonoscopy
Time frame: duration of procedure
success of cecal intubation
Time frame: duration of study
willingness to repeat colonoscopy
Time frame: duration of study
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 11 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy for colorectal cancer screening, Water Infusion Colonoscopy and Air insufflation colonoscopy in people with Colorectal Cancer, run by East Bay Institute for Research and Education at 1 site in United States.
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 3 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 11 Feb 2009. 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 United States. 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?
Increments of medications used for sedation (time frame: duration of procedure). 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 11 Feb 2009.