Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

NCT00693290 | Unknown DMC

• 1 other identifier: 07/NIR03/40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
2. 2.Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
3. 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. 4.Does body weight affect perceived tolerability of either group?

Conditions

Colorectal Cancer

Keywords

Colonoscopy; Colorectal screening; Colon preparation

Outcome Measures

Primary Outcomes (1)

• Clarity of the mucosa evaluated by the Ottawa Scale.

  At endoscopy screening

Secondary Outcomes (1)

• Concordance with the bowel preparation.

  Prior to the endoscopy

Study Arms (2)

1

ACTIVE COMPARATOR

Fleet plus low residue diet sheet.

Other: low residue diet

2

NO INTERVENTION

No intervention, usual care, Fleet plus liquid only diet

Interventions

low residue diet OTHER

Fleet (usual preparation) plus diet sheet for low residue diet

Also known as: Sodium Phosphate

1

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending for Colonoscopy.
• Patients referred for colonoscopy via General Practitioner.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• Action Cancer: collaborator
• Western Health and Social Care Trust: collaborator

Study Sites (1)

Western Health and Social Care Trust

Londonderry, Northern Ireland, BT476SB, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sodium phosphate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daphne Garrett

  Western Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Garrett

CONTACT

287-134-5171; daphne.garrett@westerntrsut.hscni.net

Siobhan McCann, PhD

CONTACT

287-137-5354; sm.mccann@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 9, 2008

Record last verified: 2008-06

Locations

GB (1)