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Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Ulster.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
University of Ulster
Collaborators:
Action Cancer
Western Health and Social Care Trust
Information provided by:
University of Ulster
ClinicalTrials.gov Identifier:
NCT00693290
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008
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Purpose
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:
- Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
- Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
- Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow−up?
- Does body weight affect perceived tolerability of either group?
| Condition | Intervention |
|---|---|
| Colorectal Cancer | Other: low residue diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy |
Resource links provided by NLM:
Further study details as provided by University of Ulster:
Primary Outcome Measures:
- Clarity of the mucosa evaluated by the Ottawa Scale. [ Time Frame: At endoscopy screening ]
Secondary Outcome Measures:
- Concordance with the bowel preparation. [ Time Frame: Prior to the endoscopy ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693290
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693290
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
| Responsible Party: | Mrs Daphne Garrett, Western Health & Social Care Trust |
| ClinicalTrials.gov Identifier: | NCT00693290 History of Changes |
| Other Study ID Numbers: |
07/NIR03/40 |
| Study First Received: | June 5, 2008 |
| Last Updated: | June 6, 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 |
ClinicalTrials.gov processed this record on July 24, 2017