ObeseNCT01616602
Prone Versus Left-sided Colonoscopy in Obese Patients
A study testing Prone Position and Standard Position in people with Obese, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- Prone Position and Standard Position
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >30kg/m2
- Elective Colonoscopy
Who cannot join
- Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.
- Patients who are scheduled to have monitored or general anesthesia for their procedure.
- Emergency colonoscopy
- Inadequate preparation of the colon as assessed during colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.
- Conditions
- Obese
- Being tested
- Prone Position, Standard Position
- Keywords
- patients, presenting, elective, colonoscopy.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositionOther
Patients were asked to lay on their abdomen for their elective colonoscopy.
Standard PositionOther
The traditional left-lateral decubitus position
| Study group | Role | What they receive |
|---|---|---|
| Left-sided Position | Placebo comparator | Not described Receives: Other: Standard Position |
| Prone Position | Experimental | Not described Receives: Other: Prone Position |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616602
- Sponsor's protocol ID
- DVAMC-10-098
- Status last verified
- Dec 2011
- First submitted
- 8 Jun 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Versus Left-sided Colonoscopy in Obese Patients
- ClinicalTrials.gov ID
- NCT01616602
- Acronym / sponsor ID
- DVAMC-10-098
- Conditions
- Obese
- Keywords
- patients, presenting, elective, colonoscopy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- First posted
- 12 Jun 2012 (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.
For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left-sided Position | Placebo comparator | Other: Standard Position |
| Prone Position | Experimental | Other: Prone Position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >30kg/m2
- Elective Colonoscopy
Key exclusion criteria (4 listed)
- Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.
- Patients who are scheduled to have monitored or general anesthesia for their procedure.
- Emergency colonoscopy
- Inadequate preparation of the colon as assessed during colonoscopy
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 |
|---|---|---|
| Prone PositionPatients were asked to lay on their abdomen for their elective colonoscopy. | Other | Prone Position |
| Standard PositionThe traditional left-lateral decubitus position | Other | Left-sided Position |
Primary outcome
Not reported in the source record.
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 12 Jun 2012.
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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 Prone Position and Standard Position in people with Obese, run by Dallas VA Medical Center 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 2 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 12 Jun 2012. 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.
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 12 Jun 2012.