Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Ulster University

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Other: low residue diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00693290

07/NIR03/40

Details and patient eligibility

About

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?

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Fleet plus low residue diet sheet.

Treatment:

Other: low residue diet

2

No Intervention group

Description:

No intervention, usual care, Fleet plus liquid only diet