NCT00460837

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 colorectal-cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

First QC Date

March 23, 2007

Last Update Submit

July 23, 2010

Conditions

Colorectal Cancer

Keywords

colorectal cancerbowel preparation regimenpatients with symptoms attributable to colorectal cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Comparison of per polyp specificity between the two preparation regimens

    1 day (analysis time)

Study Arms (2)

1 A

ACTIVE COMPARATOR

gastrofin \& Picolax

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

2

ACTIVE COMPARATOR

senna

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

Interventions

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

The intervention is a bowel cleansing procedure

1 A2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with symptoms attributable to colorectal cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David Burling

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2007

First Posted

April 17, 2007

Study Start

November 1, 2007

Study Completion

March 1, 2009

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

GB(1)