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Nurse endoscopy of the colon; a randomized trial on accuracy, patient experiences and costs


- candidate number4115
- NTR NumberNTR1458
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2008
- Secondary IDsZonMW 94507728
- Public TitleNurse endoscopy of the colon; a randomized trial on accuracy, patient experiences and costs
- Scientific TitleNurse endoscopy of the colon; a randomized trial on accuracy, patient experiences and costs
- ACRONYMNurse endoscopy
- hypothesisNo difference between the performances of nurse and physician endoscopists
- Healt Condition(s) or Problem(s) studiedEndoscopic treatment, Nurse practitioner , Colonoscopy
- Inclusion criteria1. Patients referred for sigmoidoscopy or colonoscopy
2. Informed consent
- Exclusion criteria1. Therapeutic endoscopy
2. Patients referred for diagnostic sigmo- or colonoscopy who are participating in the screening project for colorectal cancer
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate1-sep-2010
- Target number of participants4000
- InterventionsDiagnostic sigmo- or colonoscopy
- Primary outcome- Endoscopic quality:
* missed lesions
* cecal intubation rates
* withdrawal time
* complications
- Secondary outcome- Patient experiences:
* pain
* stress
* Qol
* satisfaction
* preferences
- TimepointsStart: 1-9-2007
End: 1-9-2010
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESResearch physician P.G. Putten, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. E.J. Kuipers
- Sponsor/Initiator Erasmus Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsExpected in 2010
- Brief summary OBJECTIVE:
To compare accuracy, patient experiences and costs of lower gastrointestinal (GI) endoscopy (sigmoidoscopy and colonoscopy) between nurse and physician endoscopists.

DESIGN:
Randomized, Multicenter study.

STUDY POPULATION:
Patients referred for diagnostic lower GI endoscopy.

INTERVENTION:
Lower GI endoscopy performed by nurse (n=6) or physician endoscopists (n=6).

OUTCOME PARAMETERS:
Primary: Diagnostic accuracy for lesions; Secondary: Patient experiences (complications; pain/discomfort during and symptoms after the procedure, satisfaction, preferences); Costs/cost-effectiveness.

STATISTICAL ANALYSES:
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.

ECONOMIC EVALUATION:
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)
- RECORD24-sep-2008 - 8-okt-2008


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