Therefore, in the DUET-trial we will investigate whether double J stenting is indeed superior to the use of an external stent in reducing the number of urological complications after kidney transplantation, as measured by the number of PCN…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study endpoint is the number of percutaneous nephrostomy (PCN)
drainages.
Secondary outcome
The secondary study parameters are the number of urinary tract infections,
macroscopic haematuria, radiological interventions, surgical re-interventions
and stent obstruction or dysfunction. Additionally, a quality of life and cost
effectiveness analysis will be performed by using questionnaires. Validated
questionnaires for pain, quality of life, health state, work efforts and
disabilities in daily life are measured by the VAS, Euro-Qol, SF-36 and *Werk
en Zorg*.
Background summary
Urological complications after kidney transplantation, such as urinary leakage
and ureteral strictures, are associated with significant morbidity, surgical or
radiological re-interventions, prolonged hospital stay and even mortality. The
majority of urological complications are related to the ureteroneocystostomy.
Stent placement can minimize the number of urological complications. Two types
of ureteral stents can be used; mainly divided in internal double J stents and
external single J stents. In our center, we have used an external stent for
several years and urological complications are reported up to 9% of the kidney
transplant recipients. However, in literature several studies even report less
urological complications using a double J stent (0-5,4%). Unfortunately, all
these studies have a retrospective design and no prospective randomized
controlled trials are available.
Study objective
Therefore, in the DUET-trial we will investigate whether double J stenting is
indeed superior to the use of an external stent in reducing the number of
urological complications after kidney transplantation, as measured by the
number of PCN placements.
Study design
This will be a single-centre randomized controlled trial with a superiority
design. Since patients and physicians will notice post-operatively the presence
of an external stent, the study cannot be blinded. Participants will be
included during a period of 3 years, 100 recipients each year. Last follow-up
moment of all questionnaires will 6 months after transplantation.
Intervention
Randomization between double J and external stenting.
In the group which randomized to double-J stents, an additional cystoscopy will
be required in order to remove the stent. Furthermore, both groups are asked to
fill in questionnaires at 4 different time points.
Study burden and risks
Participants will be need 15min to finish 1 questionnaire. (4X15min= 60min in
total)
In addition, the patients who randomized to the double-J stent must undergo a
cystoscopy to remove the stent after 3 weeks. This intervention will be
conducted at the outpatient clinic of the department of urology. This is done
under local anesthesia, with an antibiotic prophylaxis. Patients may leave the
hospital after about 30min.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All adult kidney transplant recipients that will be transplanted at the Erasmus University Medical Center (>18yrs) are invited to participate.
Exclusion criteria
Patients will be excluded if they do not understand the Dutch language sufficiently to sign the informed consent forms and to fill in the questionnaires, or if they have a reconstructed urinary tract or conduit after total or partial cystectomy, a bladder dysfunction that requires continuous or intermittent catheterization, or will receive a donor kidney with more than one ureter. In addition, patients with primary FSGS and residual urine production will be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59551.078.16 |