Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
- Conditions
- Stones, Kidney
- Interventions
- Procedure: Flexible ureteroscopy for renal calculi less than 20 mm
- Registration Number
- NCT04643145
- Lead Sponsor
- Mansoura University
- Brief Summary
Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.
Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.
The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.
- Detailed Description
Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.
Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.
The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 1- Adult patients (aged >18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.
- Residual ureteral or renal stones after the procedure as documented by the surgeon
- Patients who will need auxiliary procedures (ESWL , re-FURS or PCNL)
- Preoperative febrile UTI
- pregnancy or breastfeeding
- Bilateral ureteroscopic surgery
- Single kidney
- Chronic kidney disease
- Cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ureteral catheter Flexible ureteroscopy for renal calculi less than 20 mm This group will receive ureteral catheter for 2 days after the procedure Indwelling double J stent Flexible ureteroscopy for renal calculi less than 20 mm This group will receive indwelling double J stent for 2-4 weeks after the procedure
- Primary Outcome Measures
Name Time Method Stone free rate 12 weeks after the procedure presence of residual fragments on non contrast computed tomography
- Secondary Outcome Measures
Name Time Method perioperative complications First 3 days postoperative perioperative complications after the procedure
Postoperative pain by visual analogue scale first 24 hours postoperatively Visual analogue scale will be assessed postoperative
Trial Locations
- Locations (1)
Urology and Nephrology Center
🇪🇬Mansoura, DK, Egypt