Reduction of Stent Associated Morbidity by Minimizing Stent Material.

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Ureteral Stent Related Morbidity

Treatments: Device: ureteral stenting with standard or modified ureteral stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03217318

CTU 16.028 EKOS 17-00496

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney stone(s) and/or ureteral stone(s) at the iliacal vessel crossing of the ureter or proximally
• Indication for ureteral stenting for the preparation of a secondary intervention
• Informed consent

Exclusion criteria

• Patients younger than 18 years
• Bilateral ureteral stenting
• Stenting because of malignant obstruction
• Mentally retarded patients
• Obstructive pyelonephritis at the time of stent insertion
• Additional operations performed during the stent indwelling time

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

ureteral stenting with standard ureteral stent

Active Comparator group

Description:

Group 1 will receive a standard ureteral stent. Diameter: 6F, length according to surgeons' estimation and patient's height.

Treatment:

Device: ureteral stenting with standard or modified ureteral stent

ureteral stenting with suture-stent

Active Comparator group

Description:

In Group 2, a modification of the standard ureteral stent will be inserted. The stent will be cut through obliquely according to the position of the ureteral calculus. The extend to be removed can be easily measured by the retrograde probing catheter and is replaced by a monofilament, non-absorbable suture as described previously by Vogt et al. (W J Urol, 2015). This suture can be easily attached by puncturing the bevelled stent end.

Treatment:

Device: ureteral stenting with standard or modified ureteral stent