Impact of Ureteral Stent Size on the Management of Post Ureteroscopy Pain: a Randomized Single Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string
研究概览
简要总结
The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Patients undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure.
排除标准
- •Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used).
- •Patient undergoing ureteroscopy for any indication other than stone extraction.
- •Patients who are currently pregnant as determined by clinical presurgical screening.
研究组 & 干预措施
Group B: 7 Fr Ureteral stents
干预措施: 7 Fr Ureteral stents (Device)
Group A: 4.8 Fr Ureteral stents
干预措施: 4.8 Fr Ureteral stents (Device)
结局指标
主要结局
Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string
时间窗: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)
Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.
次要结局
- Volume of post-operative correspondence between patients and medical system.(14 days)