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Reduction of Stent Associated Morbidity by Minimizing Stent Material.

NCT03217318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-01-27

No results posted yet for this study

Summary

After providing informed consent, patients will be randomized into one of two groups (single-blinded): Group 1 will receive a standard Percuflex® (Boston scientific) ureteral stent. Diameter: 6F, length according to surgeons' estimation. Patients in Group 2 will receive a Suture-Stent adjusted to the individual stone location.

All participant receive standardized patient information, using a validated leaflet on ureteral stenting and associated morbidity.

In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1 week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of "baseline symptoms". During secondary stone removal, stents are removed and ureteral dilatation / access is assessed.

The removed stents will be assessed for biofilm formation within the framework of an approved and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential complications and adverse events are assessed at all scheduled and unscheduled patient visits.

Conditions

  • Ureteral Stent Related Morbidity

Interventions

DEVICE

ureteral stenting with standard or modified ureteral stent

Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2020-01-22
Completion
2020-01-22

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217318 on ClinicalTrials.gov