Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

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 or disease	Intervention/treatment	Phase
Colorectal Cancer	Other: low residue diet	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
Study Start Date :	June 2008
Estimated Primary Completion Date :	December 2008
Estimated Study Completion Date :	December 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Sodium Phosphate
No Intervention: 2; No intervention, usual care, Fleet plus liquid only diet

Outcome Measures

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Primary Outcome Measures :

1. Clarity of the mucosa evaluated by the Ottawa Scale. [ Time Frame: At endoscopy screening ]

Secondary Outcome Measures :

1. Concordance with the bowel preparation. [ Time Frame: Prior to the endoscopy ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 80 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mrs Daphne Garrett, Western Health & Social Care Trust
ClinicalTrials.gov Identifier:	NCT00693290 History of Changes
Other Study ID Numbers:	07/NIR03/40
First Posted:	June 9, 2008
Last Update Posted:	June 9, 2008
Last Verified:	June 2008

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