Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

NCT ID: NCT00693290

Last Updated: 2008-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colonoscopy Colorectal screening Colon preparation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Fleet plus low residue diet sheet.

Group Type ACTIVE_COMPARATOR

low residue diet

Intervention Type OTHER

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

2

No intervention, usual care, Fleet plus liquid only diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

low residue diet

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sodium Phosphate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Action Cancer

OTHER

Sponsor Role collaborator

Western Health and Social Care Trust

OTHER

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Western Health & Social Care Trust

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daphne Garrett

Role: PRINCIPAL_INVESTIGATOR

Western Health and Social Care Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western Health and Social Care Trust

Londonderry, Northern Ireland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daphne Garrett

Role: CONTACT

Phone: 287-134-5171

Email: [email protected]

Siobhan McCann, PhD

Role: CONTACT

Phone: 287-137-5354

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daphne Garrett

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07/NIR03/40

Identifier Type: -

Identifier Source: org_study_id