Bowel Cancer ScreeningPhase 4NCT01865721
Optimizing the Use of Entonox® During Screening Colonoscopy
A Phase 4 study testing Entonox in people with Bowel Cancer Screening and Analgesia, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required. Both these methods are used in the published studies of Entonox and in clinical practice. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Bowel Cancer Screening, Analgesia, Entonox
- What is being tested?
- Entonox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Apr 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a bowel cancer screening programme colonoscopy
Who cannot join
- Contraindications to Entonox
- Previous bowel resections
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.
Both these methods are used in the published studies of Entonox and in clinical practice.
Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration
- Conditions
- Bowel Cancer Screening, Analgesia, Entonox, Colonoscopy
- Being tested
- Entonox
- Keywords
- Bowel cancer screening, Analgesia, Entonox, Pain, Side effects, Colonoscopy
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntonoxDrug
Entonox will be used according to the allocated method
| Study group | Role | What they receive |
|---|---|---|
| Continuous administration of Entonox | Active comparator | Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy Receives: Drug: Entonox |
| As required administration of Entonox | Active comparator | Patients randomised to this arm will be asked to use Entonox if and when they have pain Receives: Drug: Entonox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge
Measured: Day 1: Prior to discharge from endoscopy department
Secondary outcomes (5)
Pain scores
Patients will be asked about their experience of pain during colonoscopy. In addition patients will be asked about their overall recollection of pain immediately after colonoscopy and 1-3 days following colonoscopy.
Measured: Day 1-4: Prior to discharge and 1-3 days later
Use of analgesia and sedation
Patients additional use of sedation and analgesia will be compared in each treatment arm
Measured: Day 1: During colonoscopy
Patients satisfaction
Patients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later
Measured: Day 1-4: Prior to discharge and 1-3 days later
Willingness to have a repeat colonoscopy
Patients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy
Measured: Day 1: Prior to discharge
Side Effects
Patients will be asked about the presence of side effects during colonoscopy. This will be quantified according to whether it limited the use Of Entonox.
Measured: Day 1: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 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 Bowel Cancer ScreeningStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865721
- Sponsor's protocol ID
- STH16359
- Other IDs
- 2012-003342-33
- Status last verified
- Sep 2019
- First submitted
- 21 May 2013
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ball AJ, Din S, Donnelly M, Riley SA. A randomized controlled trial comparing continuous and as-required nitrous oxide use during screening colonoscopy. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):271-8. doi: 10.1097/MEG.0000000000000281.
PubMed 25629571
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01865721
- Acronym / sponsor ID
- STH16359
- Conditions
- Bowel Cancer Screening, Analgesia, Entonox, Colonoscopy
- Keywords
- Bowel cancer screening, Analgesia, Entonox, Pain, Side effects, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 May 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.
This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.
Both these methods are used in the published studies of Entonox and in clinical practice.
Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous administration of Entonox | Active comparator | Drug: EntonoxPatients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy |
| As required administration of Entonox | Active comparator | Drug: EntonoxPatients randomised to this arm will be asked to use Entonox if and when they have pain |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having a bowel cancer screening programme colonoscopy
Key exclusion criteria (2 listed)
- Contraindications to Entonox
- Previous bowel resections
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 |
|---|---|---|
| EntonoxEntonox will be used according to the allocated method | Drug | As required administration of Entonox, Continuous administration of Entonox |
Primary outcome
Pain scores
Time frame: Day 1: Prior to discharge from endoscopy department
Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge
5 secondary outcomes
Pain scores
Time frame: Day 1-4: Prior to discharge and 1-3 days later
Use of analgesia and sedation
Time frame: Day 1: During colonoscopy
Patients satisfaction
Time frame: Day 1-4: Prior to discharge and 1-3 days later
Willingness to have a repeat colonoscopy
Time frame: Day 1: Prior to discharge
Side Effects
Time frame: Day 1: During colonoscopy
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 23 Sep 2019.
- Derived from this study: PubMed 25629571Ball AJ, Din S, Donnelly M, Riley SA. A randomized controlled trial comparing continuous and as-required nitrous oxide use during screening colonoscopy. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):271-8. doi: 10.1097/MEG.0000000000000281.
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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 Hospital
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 Entonox in people with Bowel Cancer Screening and Analgesia, 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 1 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 23 Sep 2019. 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?
Pain scores (time frame: Day 1: Prior to discharge from endoscopy department). 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 NCT01865721, 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 23 Sep 2019; AzTrials last refreshed its copy on 1 Nov 2026.