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Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
low residue diet
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Colorectal screening, Colon preparation

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients attending for Colonoscopy.
  • Patients referred for colonoscopy via General Practitioner.

Exclusion Criteria:

  • Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
  • Previous episodes of total or partial small bowel obstruction
  • Previous colonic surgery
  • Known swallowing disorder
  • Pregnancy
  • Extremes of age (Less than 16 or greater than 80)
  • Small Intestine disorders
  • Renal Insufficiency (Serum Creatinine> 110)
  • Congestive Heart failure
  • Presence of ascites
  • Severe Colitis

Sites / Locations

  • Western Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Fleet plus low residue diet sheet.

No intervention, usual care, Fleet plus liquid only diet

Outcomes

Primary Outcome Measures

Clarity of the mucosa evaluated by the Ottawa Scale.

Secondary Outcome Measures

Concordance with the bowel preparation.

Full Information

First Posted
June 5, 2008
Last Updated
June 6, 2008
Sponsor
University of Ulster
Collaborators
Action Cancer, Western Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00693290
Brief Title
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
Official Title
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulster
Collaborators
Action Cancer, Western Health and Social Care Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure. The principal research questions are: Does the use of a low residue diet increase patient concordance to the bowel preparation instructions? Does the use of a low residue diet decrease the adequacy of assessment of the mucosa? Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up? Does body weight affect perceived tolerability of either group?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colonoscopy, Colorectal screening, Colon preparation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fleet plus low residue diet sheet.
Arm Title
2
Arm Type
No Intervention
Arm Description
No intervention, usual care, Fleet plus liquid only diet
Intervention Type
Other
Intervention Name(s)
low residue diet
Other Intervention Name(s)
Sodium Phosphate
Intervention Description
Fleet (usual preparation) plus diet sheet for low residue diet
Primary Outcome Measure Information:
Title
Clarity of the mucosa evaluated by the Ottawa Scale.
Time Frame
At endoscopy screening
Secondary Outcome Measure Information:
Title
Concordance with the bowel preparation.
Time Frame
Prior to the endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients attending for Colonoscopy. Patients referred for colonoscopy via General Practitioner. Exclusion Criteria: Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required) Previous episodes of total or partial small bowel obstruction Previous colonic surgery Known swallowing disorder Pregnancy Extremes of age (Less than 16 or greater than 80) Small Intestine disorders Renal Insufficiency (Serum Creatinine> 110) Congestive Heart failure Presence of ascites Severe Colitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Garrett
Phone
287-134-5171
Ext
3761
Email
daphne.garrett@westerntrsut.hscni.net
First Name & Middle Initial & Last Name or Official Title & Degree
Siobhan McCann, PhD
Phone
287-137-5354
Email
sm.mccann@ulster.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Garrett
Organizational Affiliation
Western Health and Social Care Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Health and Social Care Trust
City
Londonderry
State/Province
Northern Ireland
ZIP/Postal Code
BT476SB
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Garrett
Phone
287-134-5171
Ext
3761
Email
daphne.garrett@westerntrsut.hscni.net

12. IPD Sharing Statement

Learn more about this trial

Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

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