Reduction of Stent Associated Morbidity by Minimizing Stent Material.

NCT ID: NCT03217318

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2020-01-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ureteral stenting with standard ureteral stent

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

Group Type: ACTIVE_COMPARATOR

ureteral stenting with standard or modified ureteral stent

Intervention Type: DEVICE

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

ureteral stenting with suture-stent

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.

Group Type: ACTIVE_COMPARATOR

ureteral stenting with standard or modified ureteral stent

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Dominik Abt

Principal Investigator, Senior Physician Dept. of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

Other Identifiers

CTU 16.028 EKOS 17-00496

Identifier Type: -

Identifier Source: org_study_id