Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial

Mansoura University

Status: Active, not recruiting

Conditions: Stones, Kidney

Treatments: Procedure: Flexible ureteroscopy for renal calculi less than 20 mm

Study type: Interventional

Funder types: Other

Identifiers

NCT04643145

AE 201121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Ureteral catheter

Active Comparator group

Description:

This group will receive ureteral catheter for 2 days after the procedure

Treatment:

Procedure: Flexible ureteroscopy for renal calculi less than 20 mm

Indwelling double J stent

Active Comparator group

Description:

This group will receive indwelling double J stent for 2-4 weeks after the procedure

Treatment:

Procedure: Flexible ureteroscopy for renal calculi less than 20 mm