NCT03217318

Reduction of Stent Associated Morbidity by Minimizing Stent Material.

Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-07-15
• Primary completion: 2020-01-22
• Completion: 2020-01-22
• First posted: 2017-07-14
• Last updated: 2020-01-27

Locations

1 site across 1 country: Switzerland