Effectiveness of drainage of the kidney by percutaneous nephrostomy catheter placement versus retrograde double J catheter placement in patients with symptoms of obstructive kidney disease caused by uroithiasis.

Recruiting

Conditions: 10046708
Urolithiasis
nierstenen

Registration Number: NL-OMON52865

Lead Sponsor: Alrijne ziekenhuis namens de Nederlandse Vereniging voor Urologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 204

Inclusion Criteria

- Male/female >18 years
- 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 (from logistics point of view
as well as in the best interest of the patient) in opinion of the treating
physician
- Coagulation status is acceptable for both procedures, possibly corrected by
additional medication
- Willing and able to comply with filling in questionnaires and follow-up
regiment.

Exclusion Criteria

- Analphabetic or not mastering the Dutch language
- Pregnancy
- Contraindication for either technique looking at history and anatomy (e.g.
kidney transplant, pouch, Bricker deviation, urethral or ureteral stenosis)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is time to clinical recovery.<br /><br>Clinical recovery is defined as reaching one or more of the following criteria.<br /><br>The mandatory amount of criteria to achieve clinical recovery is dependent on<br /><br>the indication for placement of a PCN or a JJ (e.g. if the indication for<br /><br>placement is infection and pain, one is considered clinically recovered if the<br /><br>criteria for infection and pain is reached).<br /><br><br /><br>- Infection: improvement of infection, indicated by a decrease of WBC in two<br /><br>executive laboratory results and below 15.000 mm3 and a body temperature of<br /><br>36-38.5 C, with no recurrence of a temperature outside of these boundries<br /><br>within 24 hours if measured.<br /><br>and/or<br /><br>- Pain: NRS considering pain resulting from a renal colic is improved and < 3<br /><br>points<br /><br>and/or<br /><br>- Kidney function: improvement of creatinine/GFR in two executive laboratory<br /><br>results</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As the secondary objective we would like to investigate if there is any<br /><br>difference in PROMS and societal costs between the PCN arm and the JJ arm.<br /><br><br /><br>Secondary outcomes are further clinical data, PROMS (measured by the EQ-5D-5L,<br /><br>NRS, a satisfaction scale and further disease specific questions) and societal<br /><br>costs (measured by a disease-specified iMCQ questionnaire).</p><br>