urolithiasis
Conditions
Interventions
Placement of a nephrostomy versus placement of a double J catheter
Sponsors
Leading the Change
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria In order to be considered eligible to participate in this study, a subject must meet all of the following criteria: ? Male/female >18 year ? Symptoms and/or laboratory results indicating obstructive kidney disease with or without infection. ? A kidney or ureteral stone is present on ultrasound or CT (max 3 months old prior to presentation) ? Both drainage techniques are feasible and safe in opinion of the treating physician (from logistics point of view and in the best interest of the patient). ? Willing and able to comply with filling in questionnaires and follow-up regiment
Exclusion criteria
Exclusion criteria: Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: ? Analphabetic or not mastering the Dutch language ? Pregnancy ? Usage of anticoagulation agents other than acetylsalicylic acid. ? Contraindication for either technique looking at history and anatomy (e.g. kidney transplant, pouch, Bricker deviation, urethral or ureteral stenosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is time to clinical recovery. Clinical recovery is defined as reaching one or more of the following criteria. The mandatory amount of criteria to achieve clinical recovery is dependent on the indication for placement of a PCN or a JJ. - If indication for drainage is infection: improvement of infection, indicated by a decrease of WBC in two executive laboratory results and below 15.000 mm3 and a body temperature of 36-38.5 C. and/or - If indication for drainage is untreatable pain: Numeric rating score (NRS) considering pain resulting from a renal colic is improved and < 3 points and/or - If indication for drainage is deterioration of kidney function: improvement of creatinine/ Glomerular Filtration Rate (GFR) in two executive laboratory results It may occur that the indication for drainage is a combination of the above named indications. Clinical recovery will then be reached in case all parameters related to the different indications are within the set range. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are further clinical data, PROMS (measured by the EQ-5D-5L, NRS, a satisfaction scale and a catheter questionnaire) and societal costs (measured by a disease-specified iMCQ questionnaire). | — |
Contacts
Public ContactNora Hendriks
Alrijne Ziekenhuis en Amsterdam UMC
Outcome results
None listed