Stent or Nephrostomy
- Conditions
- <p>urolithiasis</p>10046708
- Registration Number
- NL-OMON22950
- Lead Sponsor
- eading the Change
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 204
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 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>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.</p><br>
- Secondary Outcome Measures
Name Time Method <p>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).</p><br>