Is blinding the endoscopists to bowel preparations in randomised controlled trials a reality?
| ISRCTN | ISRCTN45620422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45620422 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/09/2005
- Registration date
- 11/10/2005
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Holger Schunemann
Scientific
Scientific
Division of Clinical Research Development and Information Translation (INFORMA)
Italian National Cancer Institute/Istituto Regina Elena
Rome
-
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | |
| Study acronym | PEG, NaP |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral sodium phosphate and polyethylene glycol |
| Primary outcome measure | 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 study start date | 31/07/2003 |
| Completion date | 25/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 114 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/07/2003 |
| Date of final enrolment | 25/08/2004 |
Locations
Countries of recruitment
- Italy
- United States of America
Study participating centre
Division of Clinical Research Development and Information Translation (INFORMA)
Rome
-
Italy
-
Italy
Sponsor information
State University of New York at Buffalo (USA)
University/education
University/education
The Office of Graduate Medical Education
117 Cary hall
3435 Main street
Buffalo
14214
United States of America
| Website | http://www.smbs.buffalo.edu/gme/ |
|---|---|
"ROR" |
https://ror.org/01y64my43 |
Funders
Funder type
University/education
The office of graduate medical education at the State University of New York, Buffalo (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2006 | Yes | No |
