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Supply of adequate label was not provided to the MHRA
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 A | Active Comparator | gastrofin & Picolax |
|
| 2 | Active Comparator | senna |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bowel preparation: senna & gastrofin versus picolax (standard) | Drug | The intervention is a bowel cleansing procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of per polyp specificity between the two preparation regimens | 1 day (analysis time) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Burling | St Mark's Hospital, North West London Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mark's Hospital, North West London Hospitals NHS Trust | London | Middlesex | HA1 3UJ | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |