Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ureteral Stent Related Morbidity
- Sponsor
- Cantonal Hospital of St. Gallen
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dominik Abt
Principal Investigator, Senior Physician Dept. of Urology
Cantonal Hospital of St. Gallen
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
Outcomes
Primary Outcomes
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
Time Frame: One week after stent insertion and 2-6 weeks after removal
Difference in the USSQ subscores ("Pain-Symptoms" and "Urinary-Symptoms") between standard stent and Suture-Stent (symptoms assessed one week after insertion and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal)
Secondary Outcomes
- Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent(2-6 weeks after stent insertion and 2-6 weeks after removal)
- Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention(2-6 weeks after stent insertion)
- Assessment of complications not assessed by USSQ during intervention and indwelling time (i.e. intraoperative complications, additional hospitalizations, prolongation of hospitalization, ureteral injuries)(At the time of stent insertion until 2-6 weeks after stent removal)
- Microbiological investigation of the suture-part of the Suture-stent(2-6 weeks after stent insertion)
- Assessment of medication that had to be taken in both groups(At the time of stent insertion until 2-6 weeks after stent removal)
- Differences of ureteral access with a 9.5 F ureterorenoscopy device after stenting with the new Suture-Stent or the standard ureteral stent at the time of secondary intervention (URS)(2-6 weeks after stent insertion)
- Difference in total morbidity as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire)(2-6 weeks after stent insertion and 2-6 weeks after removal)
- Difference in type of morbidity as assessed by USSQ sub-scores and single-items (e.g. equal function, work incapacity, hematuria and others) between standard ureteral stent and Suture-Stent(2-6 weeks after stent insertion and 2-6 weeks after removal)
- Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention(2-6 weeks after stent insertion)
- Comparison of practicability of Suture-Stent and standard ureteral stent(2-6 weeks after stent insertion)
- Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent(At the time of stent insertion and 2-6 weeks after insertion)