ColonoscopyROLCOLNCT02305706
Right or Left for Colonoscopy?
A study testing starting position in colonoscopy in people with Colonoscopy, run by Imperial College Healthcare NHS Trust.
Trial summary
Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients positioned in the left lateral position. However, few published studies have explored alternatives and there is consequently little evidence to support left lateral starting position over alternatives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- starting position in colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2014
- 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
- above 18 years of age,
- informed consent,
- routine or urgent procedures
Who cannot join
- emergency colonoscopy,
- scheduled intubation therapy
About this study
Official title: Does Right Rather Than Left Starting Position Lead to Quicker Completion of COLonoscopy?
Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients positioned in the left lateral position. However, few published studies have explored alternatives and there is consequently little evidence to support left lateral starting position over alternatives.
Read the detailed description
We aim to perform a randomised controlled trial of right versus left lateral starting position for colonoscopy. Primary outcome: time to caecum. Secondary outcomes: patient comfort; volume of sedation used.
- Conditions
- Colonoscopy
- Being tested
- starting position in colonoscopy
- Keywords
- insertion, patient comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
starting position in colonoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Right | Experimental | patients will be positioned on the right-lateral position at the start of colonoscopy Receives: Procedure: starting position in colonoscopy |
| Left | Active comparator | patients will be positioned on the left-lateral position at the start of colonoscopy Receives: Procedure: starting position in colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to caecum (insertion time from rectum to caecum)
insertion time from rectum to caecum
Measured: 30 minutes
Secondary outcomes (1)
patient comfort (visual analogue score)
patient comfort by visual analogue score
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305706
- Sponsor's protocol ID
- ROLCOL 1.0
- Acronym
- ROLCOL
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vergis N, Scarborough AJ, Morris JA, Hoare JM. Prone or Left for Colonoscopy? A Randomized Controlled Trial of Prone Versus Left-sided Starting Position for Colonoscopy. J Clin Gastroenterol. 2018 Nov/Dec;52(10):e82-e86. doi: 10.1097/MCG.0000000000000871.
PubMed 28644314
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Right Rather Than Left Starting Position Lead to Quicker Completion of COLonoscopy?
- ClinicalTrials.gov ID
- NCT02305706
- Acronym / sponsor ID
- ROLCOL / ROLCOL 1.0
- Conditions
- Colonoscopy
- Keywords
- insertion, patient comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Dec 2014 (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 is technically challenging. Conventionally, colonoscopy begins with patients positioned in the left lateral position. However, few published studies have explored alternatives and there is consequently little evidence to support left lateral starting position over alternatives.
Detailed description
We aim to perform a randomised controlled trial of right versus left lateral starting position for colonoscopy. Primary outcome: time to caecum. Secondary outcomes: patient comfort; volume of sedation used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right | Experimental | Procedure: starting position in colonoscopypatients will be positioned on the right-lateral position at the start of colonoscopy |
| Left | Active comparator | Procedure: starting position in colonoscopypatients will be positioned on the left-lateral position at the start of colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- above 18 years of age,
- informed consent,
- routine or urgent procedures
Key exclusion criteria (2 listed)
- emergency colonoscopy,
- scheduled intubation therapy
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 |
|---|---|---|
| starting position in colonoscopy | Procedure or surgery | Left, Right |
Primary outcome
time to caecum (insertion time from rectum to caecum)
Time frame: 30 minutes
insertion time from rectum to caecum
1 secondary outcome
patient comfort (visual analogue score)
Time frame: 5 minutes
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 3 Dec 2014.
- Derived from this study: PubMed 28644314Vergis N, Scarborough AJ, Morris JA, Hoare JM. Prone or Left for Colonoscopy? A Randomized Controlled Trial of Prone Versus Left-sided Starting Position for Colonoscopy. J Clin Gastroenterol. 2018 Nov/Dec;52(10):e82-e86. doi: 10.1097/MCG.0000000000000871.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing starting position in colonoscopy in people with Colonoscopy, run by Imperial College Healthcare NHS Trust.
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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
time to caecum (insertion time from rectum to caecum) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305706, which also lists 1 linked publication.
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 3 Dec 2014; AzTrials last refreshed its copy on 28 Oct 2026.