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

DUET Trial; DoUble j or External stenting during kidney Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21650
Enrollment
300
Registered
2018-07-19
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Urological complications in kidney transplant recipients.

Interventions

Participants who are randomized to external stenting (control group, current standard care in our center) will receive an externalised 7 French ureteric stent. Participants who are randomized to doub

Sponsors

Erasmus MC, University Medical Center Rotterdam, Dept. of Surgery, Group of Hepatopancreatobiliary and Transplant Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult kidney transplant recipients in the Erasmus University Medical Center (>18yrs) are invited to participate

Exclusion criteria

Exclusion criteria: 1. Patients with a reconstructed urinary tract or conduit after total or partial cystectomy. 2. Patients with bladder dysfunction that requires continuous or intermittent catheterization. 3. Patients who do not understand the Dutch language sufficiently to sign the informed consent forms and to fill in the questionnaires 4. Donor kidneys with more than one ureter 5. Patients with primary FSGS and residual urine production. Because FSGS is known for its quick recurrence in the kidney graft and the first sign is proteinuria. With an externalized stent we are able to distinguish between proteinuria of the transplant kidney and the native kidneys.

Design outcomes

Primary

MeasureTime frame
To assess whether Double J stenting is superior to externalized single J stenting in preventing urological complications after kidney transplantation.

Secondary

MeasureTime frame
To assess which kind of stent is superior in reducing the total amount of urological complications, radiological interventions, surgical interventions, haematuria, and urinary tract infections. Stent obstructions or dysfunctions will be scored. Additionally, a quality of life and cost effectiveness analysis will be performed with questionnaires. Validated questionnaires for pain, quality of life, health state, work efforts and disabilities in daily life are measured by VAS, Euro-Qol, SF-36 and ‘Werk en Zorg’. All questionnaires will be filled in pre-operatively and post-operatively at different time points.

Contacts

Public ContactT. Terkivatan

PO Box 2040

t.terkivatan@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)