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

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
bowel preparation: senna & gastrofin versus picolax (standard)
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring colorectal cancer, bowel preparation regimen, patients with symptoms attributable to colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St Mark's Hospital, North West London Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 A

2

Arm Description

gastrofin & Picolax

senna

Outcomes

Primary Outcome Measures

Versus standard bowel preparation
Patient experience and compliance with reduced laxative tagging versus standard preparation

Secondary Outcome Measures

Comparison of per polyp specificity between the two preparation regimens

Full Information

First Posted
March 23, 2007
Last Updated
July 23, 2010
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00460837
Brief Title
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience
Official Title
Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Supply of adequate label was not provided to the MHRA
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, bowel preparation regimen, patients with symptoms attributable to colorectal cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 A
Arm Type
Active Comparator
Arm Description
gastrofin & Picolax
Arm Title
2
Arm Type
Active Comparator
Arm Description
senna
Intervention Type
Drug
Intervention Name(s)
bowel preparation: senna & gastrofin versus picolax (standard)
Intervention Description
The intervention is a bowel cleansing procedure
Primary Outcome Measure Information:
Title
Versus standard bowel preparation
Time Frame
1 day (while on regimen + effectivness analysis time)
Title
Patient experience and compliance with reduced laxative tagging versus standard preparation
Time Frame
1 day (while on regimen)
Secondary Outcome Measure Information:
Title
Comparison of per polyp specificity between the two preparation regimens
Time Frame
1 day (analysis time)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Burling
Organizational Affiliation
St Mark's Hospital, North West London Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mark's Hospital, North West London Hospitals NHS Trust
City
London
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

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

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