Clinical trial NCT04643145: Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Official title: Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stones, Kidney
Keywords: Kidney stones
Flexible ureteroscopy
Quality of life
drainage
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1- Adult patients (aged \>18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.

Exclusion Criteria:

1. Residual ureteral or renal stones after the procedure as documented by the surgeon
2. Patients who will need auxiliary procedures (ESWL , re-FURS or PCNL)
3. Preoperative febrile UTI
4. pregnancy or breastfeeding
5. Bilateral ureteroscopic surgery
6. Single kidney
7. Chronic kidney disease
8. Cardiovascular or cerebrovascular disease
9. Hepatic dysfunction
10. Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL

Primary outcomes:
measure: Stone free rate
timeFrame: 12 weeks after the procedure
Secondary outcomes:
measure: perioperative complications
timeFrame: First 3 days postoperative
measure: Postoperative pain by visual analogue scale
timeFrame: first 24 hours postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: DK
Study officials:
affiliation: Mansoura University
name: Amr A Elsawy
role: PRINCIPAL_INVESTIGATOR
References: