Improving Outcomes for Patients Requiring Oral Bowel Prep... | NCT00693290

Studies
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

NCT00693290

Sponsor

University of Ulster

Status

Unknown status

Last Update Posted

Jun 9, 2008Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

low residue diet

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Jun 5, 2008

First Submission Date that Met QC Criteria

Jun 6, 2008

First Posted Date

Jun 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2008

Last Update Posted Date

Jun 9, 2008Estimated

Name	Class
Action Cancer	OTHER
Western Health and Social Care Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
low residue diet	Other	Fleet (usual preparation) plus diet sheet for low residue diet	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clarity of the mucosa evaluated by the Ottawa Scale.		At endoscopy screening

Secondary Outcomes

Measure	Description	Time Frame
Concordance with the bowel preparation.		Prior to the endoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daphne Garrett	Contact	287-134-5171	3761	daphne.garrett@westerntrsut.hscni.net
Siobhan McCann, PhD	Contact	287-137-5354		sm.mccann@ulster.ac.uk

Overall Officials

Name	Affiliation	Role
Daphne Garrett	Western Health and Social Care Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Health and Social Care Trust		Londonderry	Northern Ireland	BT476SB	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018279	sodium phosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided