Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Ulster.
Recruitment status was:  Not yet recruiting
Action Cancer
Western Health and Social Care Trust
Information provided by:
University of Ulster Identifier:
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008

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
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:

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 ]

Secondary Outcome Measures:
  • Concordance with the bowel preparation. [ Time Frame: Prior to the endoscopy ]

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


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00693290

Contact: Daphne Garrett 287-134-5171 ext 3761
Contact: Siobhan McCann, PhD 287-137-5354

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   
Sponsors and Collaborators
University of Ulster
Action Cancer
Western Health and Social Care Trust
Principal Investigator: Daphne Garrett Western Health and Social Care Trust
  More Information

Responsible Party: Mrs Daphne Garrett, Western Health & Social Care Trust Identifier: NCT00693290     History of Changes
Other Study ID Numbers: 07/NIR03/40
Study First Received: June 5, 2008
Last Updated: June 6, 2008

Keywords provided by University of Ulster:
Colorectal screening
Colon preparation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on May 22, 2017