Colonoscopy TechniquesNCT01816126
One-or Two Person Technique and Quality Performance of Colonoscopy
An observational study of Colonoscopy Techniques, run by Valduce Hospital at 1 site in Italy.
Trial summary
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colonoscopy Techniques
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Feb 2013to May 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: colon cancer screening population
Who may be able to join
- adult outpatients colonoscopy for screening or surveillance indications
Who cannot join
- previous colonic surgery
- poor bowel prep
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
silvia paggi, MD contact
Italy1 site, 1 recruiting
- Recruiting
Valduce Hospital
Como, 22100
silvia paggi, MD
About this study
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.
- Conditions
- Colonoscopy Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one-operator technique | Not described | |
| two-operator technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 4 months
Secondary outcomes (1)
cecal intubation time
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy TechniquesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Amato, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816126
- Sponsor's protocol ID
- 01-2013
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-or Two Person Technique and Quality Performance of Colonoscopy
- ClinicalTrials.gov ID
- NCT01816126
- Acronym / sponsor ID
- 01-2013
- Conditions
- Colonoscopy Techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (estimated)
- First posted
- 21 Mar 2013 (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.
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-operator technique | – | – |
| two-operator technique | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colon cancer screening population
Key inclusion criteria (1 listed)
- adult outpatients colonoscopy for screening or surveillance indications
Key exclusion criteria (3 listed)
- previous colonic surgery
- poor bowel prep
- inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adenoma detection rate
Time frame: 4 months
1 secondary outcome
cecal intubation time
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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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.
silvia paggi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy Techniques, run by Valduce Hospital at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 2013. 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 Italy. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact silvia paggi, MD (0039031324145), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 4 months). 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 21 Mar 2013.