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

Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: bowel preparation: senna & gastrofin versus picolax (standard)

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of per polyp specificity between the two preparation regimens	1 day (analysis time)

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust
• Investigators: Principal Investigator: David Burling, St Mark's Hospital, North West London Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Study Completion (ANTICIPATED): March 1, 2009

Study Registration Dates

• First Submitted: March 23, 2007
• First Submitted That Met QC Criteria: April 16, 2007
• First Posted (ESTIMATE): April 17, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2010
• Last Update Submitted That Met QC Criteria: July 23, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: colorectal cancer; bowel preparation regimen; patients with symptoms attributable to colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Gastrointestinal Agents; Cathartics; Picosulfate sodium
• Other Study ID Numbers: 07.senna.SMH