Colorectal CancerNCT00693290
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
A study testing low residue diet in people with Colorectal Cancer, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure. The principal research questions are: 1. Does the use of a low residue diet increase patient concordance to the bowel preparation instructions? 2. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- low residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Dec 2008
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients attending for Colonoscopy.
- Patients referred for colonoscopy via General Practitioner.
Who cannot join
- Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
- Previous episodes of total or partial small bowel obstruction
- Previous colonic surgery
- Known swallowing disorder
- Pregnancy
- Extremes of age (Less than 16 or greater than 80)
Show all 11Show fewer
- Small Intestine disorders
- Renal Insufficiency (Serum Creatinine> 110)
- Congestive Heart failure
- Presence of ascites
- Severe Colitis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Health and Social Care Trust
Londonderry, Northern Ireland, BT476SB
Daphne Garrett, 287-134-5171 ext. 3761, daphne.garrett@westerntrsut.hscni.net
About this study
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure.
The principal research questions are:
- Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
- Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
- Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up?
- Does body weight affect perceived tolerability of either group?
- Conditions
- Colorectal Cancer
- Being tested
- low residue diet
- Keywords
- Colonoscopy, Colorectal screening, Colon preparation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low residue dietOther
Also called Sodium Phosphate
Fleet (usual preparation) plus diet sheet for low residue diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fleet plus low residue diet sheet. Receives: Other: low residue diet |
| 2 | No intervention | No intervention, usual care, Fleet plus liquid only diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarity of the mucosa evaluated by the Ottawa Scale.
Measured: At endoscopy screening
Secondary outcomes (1)
Concordance with the bowel preparation.
Measured: Prior to the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Action Cancer, Western Health and Social Care Trust
- Investigators
- Daphne Garrett, Principal investigator, Western Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693290
- Sponsor's protocol ID
- 07/NIR03/40
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 9 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT00693290
- Acronym / sponsor ID
- 07/NIR03/40
- Conditions
- Colorectal Cancer
- Keywords
- Colonoscopy, Colorectal screening, Colon preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Action Cancer, Western Health and Social Care Trust
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 9 Jun 2008 (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.
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure.
The principal research questions are:
- Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
- Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
- Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up?
- Does body weight affect perceived tolerability of either group?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: low residue dietFleet plus low residue diet sheet. |
| 2 | No intervention | –No intervention, usual care, Fleet plus liquid only diet |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients attending for Colonoscopy.
- Patients referred for colonoscopy via General Practitioner.
Key exclusion criteria (11 listed)
- Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
- Previous episodes of total or partial small bowel obstruction
- Previous colonic surgery
- Known swallowing disorder
- Pregnancy
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 |
|---|---|---|
| low residue dietAlso: Sodium PhosphateFleet (usual preparation) plus diet sheet for low residue diet | Other | 1 |
Primary outcome
Clarity of the mucosa evaluated by the Ottawa Scale.
Time frame: At endoscopy screening
1 secondary outcome
Concordance with the bowel preparation.
Time frame: Prior to the endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
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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.
Daphne Garrett principal investigator
Western Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low residue diet in people with Colorectal Cancer, run by University of Ulster 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 11 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: status not confirmed, as of the sponsor's last update on 9 Jun 2008. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Garrett (287-134-5171 ext. 3761, daphne.garrett@westerntrsut.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarity of the mucosa evaluated by the Ottawa Scale. (time frame: At endoscopy screening). 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 9 Jun 2008.