Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mansoura University
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Stone free rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1- Adult patients (aged >18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Stone free rate
Time Frame: 12 weeks after the procedure
presence of residual fragments on non contrast computed tomography
Secondary Outcomes
- perioperative complications(First 3 days postoperative)
- Postoperative pain by visual analogue scale(first 24 hours postoperatively)
Investigators
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University