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
研究组 & 干预措施
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.
干预措施: ureteral stenting with standard or modified ureteral stent (Device)
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.
干预措施: ureteral stenting with standard or modified ureteral stent (Device)
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
- 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)
- 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)
- 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