Intestinal PolypsPhase 4NCT01554098
A Comparison of Two Colonoscopic Withdrawal Techniques
A Phase 4 study testing Strategy : Supine first and Strategy : dynamic first in people with Intestinal Polyps, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy. Null Hypothesis: On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intestinal Polyps
- What is being tested?
- Strategy : Supine first and Strategy : dynamic first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnostic colonoscopy
- Age >40 and <80
Who cannot join
- Inflammatory bowel disease
- Known polyposis syndrome
- Poor mobility which would limit a patients ability to turn
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals
Sheffield, South Yorkshire, S10 4GG
About this study
Official title: A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial
This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.
Null Hypothesis:
On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.
Alternative Hypothesis:
On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.
Read the detailed description
The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.
- Conditions
- Intestinal Polyps
- Being tested
- Strategy : Supine first, Strategy : dynamic first
- Keywords
- Polyp detection, Supine, Colonoscope withdrawal, Patient position, Dynamic position change
- Medical subject headings
- Intestinal Polyps, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy : Supine firstProcedure or surgery
Also called Dynamic position change, Supine position
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change.
Strategy : dynamic firstProcedure or surgery
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Strategy : supine first | Active comparator | This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
Withdrawal in supine position followed by withdrawal with dynamic position change Receives: Procedure: Strategy : Supine first |
| Strategy : dynamic first | Active comparator | This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change. Receives: Procedure: Strategy : dynamic first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic polyps
The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.
Measured: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Secondary outcomes (2)
Colonic polyps
The absolute numbers of polyps, the size of polyps and histological type of polyp detected.
Measured: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Luminal distension
Compare the luminal distension of bowel segments in the supine position and with dynamic position change
Measured: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 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 Intestinal PolypsStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Riley, MB ChB, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554098
- Sponsor's protocol ID
- STH16220
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2012
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.
PubMed 25910661
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial
- ClinicalTrials.gov ID
- NCT01554098
- Acronym / sponsor ID
- STH16220
- Conditions
- Intestinal Polyps
- Keywords
- Polyp detection, Supine, Colonoscope withdrawal, Patient position, Dynamic position change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Mar 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.
This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.
Null Hypothesis:
On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.
Alternative Hypothesis:
On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.
Detailed description
The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy : supine first | Active comparator | Procedure: Strategy : Supine firstThis study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change. Withdrawal in supine position followed by withdrawal with dynamic position change |
| Strategy : dynamic first | Active comparator | Procedure: Strategy : dynamic firstThis study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a diagnostic colonoscopy
- Age >40 and <80
Key exclusion criteria (3 listed)
- Inflammatory bowel disease
- Known polyposis syndrome
- Poor mobility which would limit a patients ability to turn
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 |
|---|---|---|
| Strategy : Supine firstAlso: Dynamic position change, Supine positionThe initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change. | Procedure or surgery | Strategy : supine first |
| Strategy : dynamic firstThe initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position. | Procedure or surgery | Strategy : dynamic first |
Primary outcome
Colonic polyps
Time frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.
2 secondary outcomes
Colonic polyps
Time frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Luminal distension
Time frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 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 28 Mar 2014.
- Derived from this study: PubMed 25910661Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.
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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.
Stuart A Riley, MB ChB principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strategy : Supine first and Strategy : dynamic first in people with Intestinal Polyps, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 28 Mar 2014. 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 Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Colonic polyps (time frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 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 NCT01554098, 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 28 Mar 2014.