Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
时间窗: 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)
次要结局
- 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)
研究者
Dominik Abt
Principal Investigator, Senior Physician Dept. of Urology
Cantonal Hospital of St. Gallen