Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00693290
• Other study ID #: 07/NIR03/40
• Status: Not yet recruiting
• Phase: N/A
• First received: June 5, 2008
• Last updated: June 6, 2008
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2008
• Source: University of Ulster
• Contact: Daphne Garrett
• Phone: 287-134-5171
• Email: daphne.garrett[@]westerntrsut.hscni.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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:

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• low residue diet
Fleet (usual preparation) plus diet sheet for low residue diet

Locations

Country	Name	City	State
United Kingdom	Western Health and Social Care Trust	Londonderry	Northern Ireland

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulster	Action Cancer, Western Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clarity of the mucosa evaluated by the Ottawa Scale.		At endoscopy screening	No
Secondary	Concordance with the bowel preparation.		Prior to the endoscopy	No