Colorectal CancerPhase 4NCT00460837
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
A Phase 4 study testing bowel preparation: senna & gastrofin versus picolax (standard) in people with Colorectal Cancer, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bowel preparation: senna & gastrofin versus picolax (standard)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2007to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with symptoms attributable to colorectal cancer
Who cannot join
- patients with known colorectal cancer referred for staging VC
- patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue
- patients deemed too frail to undergo full bowel preparation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Mark's Hospital, North West London Hospitals NHS Trust
London, Middlesex, HA1 3UJ
About this study
Official title: Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
The study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.
Read the detailed description
Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates [1-3].
Unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with VC, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. These regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. Once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged').
We are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.
- Conditions
- Colorectal Cancer
- Being tested
- bowel preparation: senna & gastrofin versus picolax (standard)
- Keywords
- colorectal cancer, bowel preparation regimen, patients with symptoms attributable to colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel preparation: senna & gastrofin versus picolax (standard)Drug
The intervention is a bowel cleansing procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 A | Active comparator | gastrofin \& Picolax Receives: Drug: bowel preparation: senna & gastrofin versus picolax (standard) |
| 2 | Active comparator | senna Receives: Drug: bowel preparation: senna & gastrofin versus picolax (standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Versus standard bowel preparation
Measured: 1 day (while on regimen + effectivness analysis time)
Patient experience and compliance with reduced laxative tagging versus standard preparation
Measured: 1 day (while on regimen)
Secondary outcomes (1)
Comparison of per polyp specificity between the two preparation regimens
Measured: 1 day (analysis time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startNov 2007
- Study completionMar 2009 (estimated)
Why it stopped: Supply of adequate label was not provided to the MHRA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- David Burling, Principal investigator, St Mark's Hospital, North West London Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460837
- Sponsor's protocol ID
- 07.senna.SMH
- Status last verified
- Jul 2010
- First submitted
- 23 Mar 2007
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
- ClinicalTrials.gov ID
- NCT00460837
- Acronym / sponsor ID
- 07.senna.SMH
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, bowel preparation regimen, patients with symptoms attributable to colorectal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Supply of adequate label was not provided to the MHRA
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Mar 2009 (estimated)
- First posted
- 17 Apr 2007 (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 will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.
Detailed description
Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates [1-3].
Unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with VC, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. These regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. Once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged').
We are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 A | Active comparator | Drug: bowel preparation: senna & gastrofin versus picolax (standard)gastrofin \& Picolax |
| 2 | Active comparator | Drug: bowel preparation: senna & gastrofin versus picolax (standard)senna |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptoms attributable to colorectal cancer
Key exclusion criteria (3 listed)
- patients with known colorectal cancer referred for staging VC
- patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue
- patients deemed too frail to undergo full bowel preparation
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 |
|---|---|---|
| bowel preparation: senna & gastrofin versus picolax (standard)The intervention is a bowel cleansing procedure | Drug | 1 A, 2 |
Primary outcome
Versus standard bowel preparation
Time frame: 1 day (while on regimen + effectivness analysis time)
Patient experience and compliance with reduced laxative tagging versus standard preparation
Time frame: 1 day (while on regimen)
1 secondary outcome
Comparison of per polyp specificity between the two preparation regimens
Time frame: 1 day (analysis time)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
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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.
David Burling principal investigator
St Mark's Hospital, North West London Hospitals NHS 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 bowel preparation: senna & gastrofin versus picolax (standard) in people with Colorectal Cancer, run by London North West Healthcare NHS 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 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: withdrawn, as of the sponsor's last update on 26 Jul 2010. 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 was withdrawn before enrolling participants, so there are no results.
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?
Versus standard bowel preparation (time frame: 1 day (while on regimen + effectivness analysis time)). The study lists 2 primary outcomes in all. 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 26 Jul 2010.