Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 A gastrofin & Picolax |
Drug: bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure
|
| Active Comparator: 2 senna |
Drug: bowel preparation: senna & gastrofin versus picolax (standard)
The intervention is a bowel cleansing procedure
|
Outcome Measures
Primary Outcome Measures
- Versus standard bowel preparation [1 day (while on regimen + effectivness analysis time)]
- Patient experience and compliance with reduced laxative tagging versus standard preparation [1 day (while on regimen)]
Secondary Outcome Measures
- Comparison of per polyp specificity between the two preparation regimens [1 day (analysis time)]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Mark's Hospital, North West London Hospitals NHS Trust | London | Middlesex | United Kingdom | HA1 3UJ |
Sponsors and Collaborators
- London North West Healthcare NHS Trust
Investigators
- Principal Investigator: David Burling, St Mark's Hospital, North West London Hospitals NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07.senna.SMH