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DUET-trial; DoUble j or External stenting during kidney Transplantation? Study-protocol

DUET-trial; DoUble j or External stenting during kidney Transplantation? Study-protocol - DUET-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47037
Enrollment
300
Registered
2017-03-09
Start date
2018-12-12
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological complications after kidney transplantatie

Interventions

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 grou

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult kidney transplant recipients that will be transplanted at the Erasmus University Medical Center (>18yrs) are invited to participate.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Our main study endpoint is the number of percutaneous nephrostomy (PCN) drainages.

Secondary

MeasureTime frame
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*.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)