Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
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ClinicalTrials.gov Identifier: NCT00693290 |
Recruitment Status
: Unknown
Verified June 2008 by University of Ulster.
Recruitment status was: Not yet recruiting
First Posted
: June 9, 2008
Last Update Posted
: June 9, 2008
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Other: low residue diet | Not Applicable |
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 |

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
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- Clarity of the mucosa evaluated by the Ottawa Scale. [ Time Frame: At endoscopy screening ]
- Concordance with the bowel preparation. [ Time Frame: Prior to the endoscopy ]

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693290
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 |
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 |
Principal Investigator: | Daphne Garrett | Western Health and Social Care Trust |
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 Key Record Dates |
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 |