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Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Ulster.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Action Cancer
Western Health and Social Care Trust
Information provided by:
University of Ulster
ClinicalTrials.gov Identifier:
NCT00693290
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008
History of Changes
  Purpose

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:

  1. Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
  2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
  3. Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow−up?
  4. Does body weight affect perceived tolerability of either group?

Condition Intervention
Colorectal Cancer
 Other: low residue diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Clarity of the mucosa evaluated by the Ottawa Scale. [ Time Frame: At endoscopy screening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concordance with the bowel preparation. [ Time Frame: Prior to the endoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Fleet plus low residue diet sheet.
 Other: low residue diet
Fleet (usual preparation) plus diet sheet for low residue diet
Other Name: Sodium Phosphate
No Intervention: 2
No intervention, usual care, Fleet plus liquid only diet

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693290

Contacts
Contact: Daphne Garrett 287-134-5171 ext 3761 daphne.garrett@westerntrsut.hscni.net
Contact: Siobhan McCann, PhD 287-137-5354 sm.mccann@ulster.ac.uk

Locations
United Kingdom
Western Health and Social Care Trust Not yet recruiting
Londonderry, Northern Ireland, United Kingdom, BT476SB
Contact: Daphne Garrett     287-134-5171 ext 3761     daphne.garrett@westerntrsut.hscni.net    
Sponsors and Collaborators
University of Ulster
Action Cancer
Western Health and Social Care Trust
Investigators
Principal Investigator: Daphne Garrett Western Health and Social Care Trust
  More Information

No publications provided

Responsible Party: Mrs Daphne Garrett, Western Health & Social Care Trust
ClinicalTrials.gov Identifier: NCT00693290     History of Changes
Other Study ID Numbers: 07/NIR03/40
Study First Received: June 5, 2008
Last Updated: June 6, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Ulster:
Colonoscopy
Colorectal screening
Colon preparation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013