ColonoscopyNCT01434927
The Clinical Acceptability of Unsedated Colonoscopy
An observational study of Colonoscopy, run by Valduce Hospital at 1 site in Italy.
Trial summary
The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Unsedated colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 964 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Apr 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.
Who may be able to join
- adult outpatients
Who cannot join
- previous colorectal surgery
- indication to a bi-directional endoscopy
- indication to a partial examination
- patients' refusal or inability to provide informed consent and
- advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unsedated Colonoscopy: An Option For Some But Not For All
The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.
Read the detailed description
Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.
- Conditions
- Colonoscopy
- Being tested
- Unsedated colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsedated colonoscopyProcedure or surgery
Patients were offered to undergo colonoscopy without routine premedication
Unsedated colonoscopyProcedure or surgery
Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy outpatients | All patients referred to our Unit to undergo colonoscopy for any indication Receives: Procedure: Unsedated colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODDS ratio for unsedated colonoscopy acceptance
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the acceptance of unsedated colonoscopy
Measured: up to 8 months
Secondary outcomes (2)
Acceptance rate of unsedated colonoscopy
Proportion of patients accepting to attempt colonoscopy without routine premedication
Measured: up to 8 months
ODDS ratios for unsedated colonoscopy completion
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the completion of unsedated colonoscopy
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
- Investigators
- Franco Radaelli, MD, Principal investigator, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434927
- Sponsor's protocol ID
- 07CE2009
- Status last verified
- Sep 2011
- First submitted
- 18 Aug 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unsedated Colonoscopy: An Option For Some But Not For All
- ClinicalTrials.gov ID
- NCT01434927
- Acronym / sponsor ID
- 07CE2009
- Conditions
- Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Sep 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 study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.
Detailed description
Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy outpatients | – | Procedure: Unsedated colonoscopyAll patients referred to our Unit to undergo colonoscopy for any indication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.
Key inclusion criteria (1 listed)
- adult outpatients
Key exclusion criteria (5 listed)
- previous colorectal surgery
- indication to a bi-directional endoscopy
- indication to a partial examination
- patients' refusal or inability to provide informed consent and
- advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)
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 |
|---|---|---|
| Unsedated colonoscopyPatients were offered to undergo colonoscopy without routine premedication | Procedure or surgery | Colonoscopy outpatients |
| Unsedated colonoscopyPatients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded | Procedure or surgery | Colonoscopy outpatients |
Primary outcome
ODDS ratio for unsedated colonoscopy acceptance
Time frame: up to 8 months
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the acceptance of unsedated colonoscopy
2 secondary outcomes
Acceptance rate of unsedated colonoscopy
Time frame: up to 8 months
ODDS ratios for unsedated colonoscopy completion
Time frame: up to 8 months
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 15 Sep 2011.
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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.
Franco Radaelli, MD principal investigator
Valduce Hospital
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, 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 5 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 15 Sep 2011. 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?
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?
ODDS ratio for unsedated colonoscopy acceptance (time frame: up to 8 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 15 Sep 2011.