NCT00212433

Brief Summary

To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

First QC Date

September 12, 2005

Last Update Submit

May 21, 2025

Conditions

Keywords

colorectal neoplasiaCT colonographyfaecal tagging

Outcome Measures

Primary Outcomes (1)

  • Which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography

Secondary Outcomes (1)

  • to compare the diagnostic performance of CT colonography after reduced bowel preparation and faecal tagging with conventional colonoscopy in patients undergoing both procedures

Interventions

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are under investigation for suspected colonic neoplasia and over 50 years old:
  • Symptomatic patients eg. change in bowel habit, rectal bleeding etc.
  • Polyp surveillance
  • Strong family history
  • suspected neoplasia on previous investigation (e.g. barium enema)

You may not qualify if:

  • patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of CT colonography in this specific patient cohort)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

London, Middlesex, HA1 3UJ, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Oxford Radcliffe Hospital NHS Trust

Oxford, United Kingdom

Location

MeSH Terms

Interventions

Barium Sulfate

Intervention Hierarchy (Ancestors)

Barium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Stuart Taylor, MD

    St Mark's Hospital, North West London NHS Trust; & University College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Study Completion

February 1, 2006

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations