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Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience

L

London North West Healthcare NHS Trust

Status and phase

Withdrawn
Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: bowel preparation: senna & gastrofin versus picolax (standard)

Study type

Interventional

Funder types

Other

Identifiers

NCT00460837
07.senna.SMH

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

1 A
Active Comparator group
Description:
gastrofin \& Picolax
Treatment:
Drug: bowel preparation: senna & gastrofin versus picolax (standard)
2
Active Comparator group
Description:
senna
Treatment:
Drug: bowel preparation: senna & gastrofin versus picolax (standard)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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