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WithdrawnNCT00460837Updated Jul 26, 2010

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

A Phase 4 interventional study of bowel preparation: senna & gastrofin versus picolax (standard) in Colorectal Cancer, sponsored by London North West Healthcare NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-26.

Sponsored by London North West Healthcare NHS Trust · Phase 4, Interventional, and Health services research

Why this study was withdrawn
Supply of adequate label was not provided to the MHRA
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • bowel preparation regimen
  • patients with symptoms attributable to colorectal cancer
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 150 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with symptoms attributable to colorectal cancer

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    1 A

    gastrofin \& Picolax

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

  • Active comparator
    2

    senna

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

Interventions

  • Drugbowel preparation: senna & gastrofin versus picolax (standard)

    The intervention is a bowel cleansing procedure

06

What researchers measure

Primary outcomes

  1. Versus standard bowel preparation

    Time frame: 1 day (while on regimen + effectivness analysis time)

  2. Patient experience and compliance with reduced laxative tagging versus standard preparation

    Time frame: 1 day (while on regimen)

Secondary outcomes

  1. Comparison of per polyp specificity between the two preparation regimens

    Time frame: 1 day (analysis time)

07

Study locations

1 site
  • St Mark's Hospital, North West London Hospitals NHS Trust
    London, Middlesex HA1 3UJ, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2007
First posted
Apr 17, 2007
Start
Nov 2007
CompletionEst.
Mar 2009
Last update
Jul 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00460837
Lead sponsor
London North West Healthcare NHS Trust
First posted
Apr 17, 2007
Start date
Nov 2007
Completion
Mar 2009 (estimated)
Last update
Jul 26, 2010

Study contacts

David Burling
principal investigator · St Mark's Hospital, North West London Hospitals NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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