Ureteral Stent Related Morbidity Clinical Trial
Official title:
Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
| Verified date | February 2019 |
| Source | Cantonal Hospital of St. Gallen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 92 |
| Est. completion date | January 22, 2020 |
| Est. primary completion date | January 22, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Urological Department, Cantonal Hospital of St. Gallen | St. Gallen |
| Lead Sponsor | Collaborator |
|---|---|
| Cantonal Hospital of St. Gallen |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent | 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) | One week after stent insertion and 2-6 weeks after removal | |
| Secondary | Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent | Difference in the USSQ subscores ("Pain-Symptoms" and "Urinary-Symptoms") between standard stent and Suture-Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal). | 2-6 weeks after stent insertion and 2-6 weeks after removal | |
| Secondary | Difference in total morbidity as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) | Difference in the USSQ total score between standard ureteral stent and Suture- Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal). | 2-6 weeks after stent insertion and 2-6 weeks after removal | |
| Secondary | 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 | Difference in the USSQ sub scores and items (i.e. general health, work performance, sexual matters, items, additional problems, GQ, assessment of haematuria: items U8 and U9) between standard ureteral stent and Suture-Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal). | 2-6 weeks after stent insertion and 2-6 weeks after removal | |
| Secondary | Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention | Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention (measured by a retrograde ureterography) at three locations of the ureter (i.e. proximal, middle and distal ureter). | 2-6 weeks after stent insertion | |
| Secondary | 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) | 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) measured by the success of: Entering the whole ureter or Insertion of an access sheath 14/12F; Complete stone removal. | 2-6 weeks after stent insertion | |
| Secondary | Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention | Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention (measured by a grading: no, light, heavy irritation) at two locations (periostial and ureteral). | 2-6 weeks after stent insertion | |
| Secondary | Comparison of practicability of Suture-Stent and standard ureteral stent | Comparison of practicability of Suture-Stent and standard ureteral stent (i.e. insertion time, problems with insertion or removal) | 2-6 weeks after stent insertion | |
| Secondary | Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent | Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent measured at time of stent removal (2-6 weeks after insertion) | At the time of stent insertion and 2-6 weeks after insertion | |
| Secondary | Microbiological investigation of the suture-part of the Suture-stent | Microbiological investigation of the suture-part of the Suture-stent: total biofilmmass, number of bacteria | 2-6 weeks after stent insertion | |
| Secondary | Assessment of complications not assessed by USSQ during intervention and indwelling time (i.e. intraoperative complications, additional hospitalizations, prolongation of hospitalization, ureteral injuries) | Assessment of complications not assessed by USSQ during intervention and indwelling time (e.g. perioperative adverse events according to Clavien-Dindo classification, stent dislocation or dysfunction during indwelling time). | At the time of stent insertion until 2-6 weeks after stent removal | |
| Secondary | Assessment of medication that had to be taken in both groups | Assessment of medication that had to be taken in both groups | At the time of stent insertion until 2-6 weeks after stent removal |