- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00460837
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Middlesex
-
London, Middlesex, United Kingdom, HA1 3UJ
- St Mark's Hospital, North West London Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with symptoms attributable to colorectal cancer
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1 A
gastrofin & Picolax
|
The intervention is a bowel cleansing procedure
|
ACTIVE_COMPARATOR: 2
senna
|
The intervention is a bowel cleansing procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Versus standard bowel preparation
Time Frame: 1 day (while on regimen + effectivness analysis time)
|
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 day (while on regimen)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of per polyp specificity between the two preparation regimens
Time Frame: 1 day (analysis time)
|
1 day (analysis time)
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Burling, St Mark's Hospital, North West London Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.senna.SMH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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