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Placement of a double-J catheter transurethral via the urinary bladder versus transcutaneous via the kidney in patients with extrinsic obstruction of the ureter.


- candidate number21042
- NTR NumberNTR4925
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2014
- Secondary IDsNL49696.098.14 METC ZWH
- Public TitlePlacement of a double-J catheter transurethral via the urinary bladder versus transcutaneous via the kidney in patients with extrinsic obstruction of the ureter.
- Scientific TitleRetrograde versus antegrade placement of a double-J cathteter in patients with extrinsic ureter obstruction.
- ACRONYMRAPPER trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedUreter, Catheter, Transurethral catheterization
- Inclusion criteria Legally capable and written informed consent 18 years or older A CT or MRI diagnosis of extrinsic ureter obstruction by visible or non-visible mass surrounding the urinary tract Possible dorsal percutaneous approach to kidney Possible transvesical approach Possible treatment by an urologist and intervention radiologist with sufficient experience Patient is willing and able to comply with the specified follow-up evaluation
- Exclusion criteria Active infection, defined as temperature >38,0 C Macroscopic haematuria INR > 2,0 Thrombocytes < 50 109/l Ileal conduit urinary diversion Kidney transplantation Horseshoe kidney Known allergy to contrast media Pregnancy
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2019
- Target number of participants214
- Interventions Retrograde placement of a double-J catheter Antegrade placemnet of a double-J catheter
- Primary outcomeImmediate technical success rate
- Secondary outcome To compare VAS scores after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction. To compare the complications after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction. To compare technical success rates at 30 days after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction. To compare scores on EQ5D questionnaire at 30 days after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction. To assess possible predictive factors for immediate technical success. To assess possible predictive factors for technical success at 30 days. To assess possible predictive factors for the evolvement of major and minor complications. To assess possible predictive factors for the outcome on the EQ5D questionnaire.
- Timepoints Intervention 7 days after intervention 30 days after intervention
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Drs. Joanne Verdult
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-nov-2014 - 1-feb-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl