Condition category
Surgery
Date applied
23/09/2005
Date assigned
11/10/2005
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Holger Schunemann

ORCID ID

Contact details

Division of Clinical Research Development and Information Translation (INFORMA)
Italian National Cancer Institute/Istituto Regina Elena
Rome
-
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PEG, NaP

Study hypothesis

The primary aim of this study was to explore whether endoscopists can be effectively blinded to the type of bowel preparation in the trials that compare the cleaning efficacy of oral sodium phosphate and polyethylene glycol

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Colonoscopy for screening, surveillance, or diagnosis of colorectal cancer

Intervention

Blinding the colonoscopists to the type of bowel preparation given prior to colonoscopy - oral sodium phosphate versus polyethylene glycol

Intervention type

Drug

Phase

Not Specified

Drug names

Oral sodium phosphate and polyethylene glycol

Primary outcome measures

The primary outcome of this study is to determine the proportion of correct estimation of the bowel preparation by all endoscopists combined

Secondary outcome measures

Secondary outcomes are the proportion of correct estimations by individual endoscopists. We are also interested in the distinguishing features that endoscopists reported as reasons for their judgments. Other secondary aims are the comparison of tolerability, safety, and overall quality of colon cleansing for the two bowel preparations.

Overall trial start date

31/07/2003

Overall trial end date

25/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All outpatient adults (18-65 years old) undergoing colonoscopy for screening, surveillance, or diagnosis of colorectal cancer at the Western NY Veterans Affairs Medical Center in Buffalo between May 2003 and August 2004 who had a basic metabolic profile blood test within one year prior to enrollment were eligible for this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

114 patients

Participant exclusion criteria

Patients were not eligible for the study if any of the following was present:
1. Evidence of renal insufficiency (creatinine >2.0 mg/dl)
2. Evidence of electrolyte abnormalities
3. Cardiovascular disease, including uncontrolled congestive heart failure (American Heart Association Functional Class III or IV), unstable angina, or myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac surgery within the past 3 months
4. Inflammatory bowel disease
5. Colon disease, including chronic constipation (<2 bowel movements per week for >one year, ileus and/or acute obstruction, hypomotility syndrome, megacolon, idiopathic pseudo-obstruction, or previous colonic surgery
6. Pregnant or breastfeeding female
A meta-analysis that included randomised controlled trials comparing the two bowel preparations showed that clinical adverse effects were comparable in frequency when patients are carefully selected

Recruitment start date

31/07/2003

Recruitment end date

25/08/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

Division of Clinical Research Development and Information Translation (INFORMA)
Rome
-
Italy

Sponsor information

Organisation

State University of New York at Buffalo (USA)

Sponsor details

The Office of Graduate Medical Education
117 Cary hall
3435 Main street
Buffalo
14214
United States of America

Sponsor type

University/education

Website

http://www.smbs.buffalo.edu/gme/

Funders

Funder type

University/education

Funder name

The office of graduate medical education at the State University of New York, Buffalo (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17113722

Publication citations

  1. Results

    El-Dika S, Mahl T, Mehboob S, Miqdadi J, Heels-Ansdell D, Handley B, Sitrin M, Sch√ľnemann H, Is blinding the endoscopists to bowel preparations in randomized-controlled trials a reality?, Cancer Detect. Prev., 2006, 30, 6, 552-559, doi: 10.1016/j.cdp.2006.10.004.

Additional files

Editorial Notes