|- candidate number||4115|
|- NTR Number||NTR1458|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-sep-2008|
|- Secondary IDs||ZonMW 94507728|
|- Public Title||Nurse endoscopy of the colon; a randomized trial on accuracy, patient experiences and costs|
|- Scientific Title||Nurse endoscopy of the colon; a randomized trial on accuracy, patient experiences and costs|
|- ACRONYM||Nurse endoscopy|
|- hypothesis||No difference between the performances of nurse and physician endoscopists|
|- Healt Condition(s) or Problem(s) studied||Endoscopic treatment, Nurse practitioner , Colonoscopy|
|- Inclusion criteria||1. Patients referred for sigmoidoscopy or colonoscopy |
2. Informed consent
|- Exclusion criteria||1. Therapeutic endoscopy|
2. Patients referred for diagnostic sigmo- or colonoscopy who are participating in the screening project for colorectal cancer
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-sep-2010|
|- Target number of participants||4000|
|- Interventions||Diagnostic sigmo- or colonoscopy|
|- Primary outcome||- Endoscopic quality:|
* missed lesions
* cecal intubation rates
* withdrawal time
|- Secondary outcome||- Patient experiences: |
|- Timepoints||Start: 1-9-2007|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Research physician P.G. Putten, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.J. Kuipers|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Expected in 2010|
|- Brief summary||
To compare accuracy, patient experiences and costs of lower gastrointestinal (GI) endoscopy (sigmoidoscopy and colonoscopy) between nurse and physician endoscopists.
Randomized, Multicenter study.
Patients referred for diagnostic lower GI endoscopy.
Lower GI endoscopy performed by nurse (n=6) or physician endoscopists (n=6).
Primary: Diagnostic accuracy for lesions; Secondary: Patient experiences (complications; pain/discomfort during and symptoms after the procedure, satisfaction, preferences); Costs/cost-effectiveness.
Each endoscopist will perform 335 lower GI endoscopies (at least 50% colonoscopies), 200 endoscopies will be performed for training according to national guidelines (Part I) and 135 for studying accuracy using back-to-back endoscopy performed by nurse or physician endoscopist and a gastroenterologist(Part IIA; n=25), and complications and patient experience (Part IIB; n=110). A non-inferior performance of nurse endoscopists compared to physician endoscopists is expected. For accuracy, pair-wise comparisons will be made (McNemar test); for patient experiences chi-square and Mann-Whithney tests.
Cost-effectiveness of nurse versus physician endoscopy will be evaluated from a societal perspective (including personnel, equipment, procedure duration, and complication costs).
|- Main changes (audit trail)|
|- RECORD||24-sep-2008 - 8-okt-2008|