Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

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?

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: low residue diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphne Garrett; Phone Number: 3761 287-134-5171; Email: daphne.garrett@westerntrsut.hscni.net
• Study Contact Backup: Name: Siobhan McCann, PhD; Phone Number: 287-137-5354; Email: sm.mccann@ulster.ac.uk

Study Locations

• United Kingdom
  • Northern Ireland
    • Londonderry, Northern Ireland, United Kingdom, BT476SB
      • Western Health and Social Care Trust
      • Contact: Daphne Garrett; Phone Number: 3761 287-134-5171; Email: daphne.garrett@westerntrsut.hscni.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Fleet plus low residue diet sheet.	Other: low residue diet; Fleet (usual preparation) plus diet sheet for low residue diet; Other Names: Sodium Phosphate
No Intervention: 2; No intervention, usual care, Fleet plus liquid only diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clarity of the mucosa evaluated by the Ottawa Scale.	At endoscopy screening

Secondary Outcome Measures

Outcome Measure	Time Frame
Concordance with the bowel preparation.	Prior to the endoscopy

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Western Health and Social Care Trust; Action Cancer
• Investigators: Principal Investigator: Daphne Garrett, Western Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2008
• Last Update Submitted That Met QC Criteria: June 6, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Colonoscopy; Colon preparation; Colorectal screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 07/NIR03/40