The primary objective is to assess whether a PCN is non-inferior to double J catheter regarding time to clinical recovery in patients with obstructive kidney disease resulting from urolithiasis.As the secondary objective we would like to investigate…
ID
Source
Brief title
Condition
- Urolithiases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 (e.g. if the indication for
placement is infection and pain, one is considered clinically recovered if the
criteria for infection and pain is reached).
- 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, with no recurrence of a temperature outside of these boundries
within 24 hours if measured.
and/or
- Pain: NRS considering pain resulting from a renal colic is improved and < 3
points
and/or
- Kidney function: improvement of creatinine/GFR in two executive laboratory
results
Secondary outcome
As the secondary objective we would like to investigate if there is any
difference in PROMS and societal costs between the PCN arm and the JJ arm.
Secondary outcomes are further clinical data, PROMS (measured by the EQ-5D-5L,
NRS, a satisfaction scale and further disease specific questions) and societal
costs (measured by a disease-specified iMCQ questionnaire).
Background summary
Urolithiasis is a common disease. If a stone obstructs the ureter and impairs
urine-efflux from the kidney this may cause infection, pain resulting from a
renal colic and/or renal impairment. Pyelonephritis combined with obstruction
can result in a life-threatening sepsis. Renal impairment may become chronic if
the obstruction is not treated adequately.
For these reasons, quick recovery of urinary passage with an adequate drainage
method is essential. This can be done by direct stone removal, but this may be
contra-indicated in case of infection, or not feasible for other reasons. In
this case there is choice between placement of a percutaneous nephrostomy
catheter (PCN) or double J catheter (JJ).
Advocates of JJ support this choice because of a better quality of life and
possible complications resulting from placement of a PCN (obstruction,
dislocation). Besides, a double J catheter might be arranged easier at their
institute. Advocates of PCN use comparable arguments: a PCN catheter gives less
trouble for the patient and can be placed more easily. In addition urine
production by the affected kidney can be monitored. A double J catheter has
complications as well (dislocation, infection, obstruction).
Combining drainage method, setting (outpatient or inpatient), room in which
drainage procedures takes place (treatment room versus operating room, OR) and
anesthesia method there are in fact 16 different approaches for drainage
available, each with its own patient and cost-perspectives. If we want to offer
these patients the most (cost-)effective treatment in a uniform and
evidence-based way, first and foremost we must know if PCN is non-inferior to
JJ regarding clinical recovery. In addition, we have to know which setting
offers most comfort to the patients, and the costs of both procedures in the
different settings.
Study objective
The primary objective is to assess whether a PCN is non-inferior to double J
catheter regarding time to clinical recovery in patients with obstructive
kidney disease resulting from urolithiasis.
As the secondary objective we would like to investigate if there is any
difference in PROMS and societal costs between the PCN arm and the JJ arm.
Study design
A multicenter prospective randomized controlled non-inferiority trial comparing
percutaneous nephrostomy catheter placement with double J catheter placement
including a cost-effectiveness study.
Study burden and risks
The placement of either PCN or double J catheter is standard care. Currently
the choice for PCN or a double J catheter is based on expert opinion and may be
driven by arguments considering logistics or assumptions about the quality of
life for a patient after placement and does not seem to be evidence based.
Considering the difference in rate of placement of both PCN and double j
catheter between various hospitals and different countries, it is believed
experts have not come to a uniform work method to handle the dilemma of
choosing between these two techniques. Furthermore the current EAU-guideline
2018 states that both methods of drainage are to be considered as equal.
Therefore there is no reason to believe, patients will be affected negatively
by being placed randomly in either the double J group or the PCN group.
Questionnaires will be filled in daily during hospitalization and twice or less
afterwards. This is not considered to be a risk for the patient. The longest
questionnaires questionnaire (EQ-5D-5L and iMCQ) will take approximately 10-20
minutes to fill in, additional to the shorter scales (NRS, satisfaction scale)
which will take approximately 1 minute to fill in. Generally It will take 90
minutes, spread over the course of three months, to fill in all questionnaires.
When final treatment of urolithiasis has taken place, questionnaires will no
longer have to be filled in. Finally, no additional visits to a hospital,
withdrawal of blood samples or exposure to radiation is to be expected when
taking part in this study.
Simon Smitweg 1
leiderdorp 2353GA
NL
Simon Smitweg 1
leiderdorp 2353GA
NL
Listed location countries
Age
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)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70822.058.19 |
| Other | NL8128 |
| OMON | NL-OMON22950 |