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

NCT ID: NCT04643145

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-12-15

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.

Conditions

Stones, Kidney

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ureteral catheter

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

Group Type: ACTIVE_COMPARATOR

Flexible ureteroscopy for renal calculi less than 20 mm

Intervention Type: PROCEDURE

Patients with renal calculi less than 20 mm will be managed by flexible ureteroscopy. at the end of the procedure, they will be randomized to receive either temporary ureteral catheter for 2 days or indweeling double J stent for 2-4 weeks

Indwelling double J stent

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

Group Type: ACTIVE_COMPARATOR

Flexible ureteroscopy for renal calculi less than 20 mm

Intervention Type: PROCEDURE

Patients with renal calculi less than 20 mm will be managed by flexible ureteroscopy. at the end of the procedure, they will be randomized to receive either temporary ureteral catheter for 2 days or indweeling double J stent for 2-4 weeks

Interventions

Flexible ureteroscopy for renal calculi less than 20 mm

Patients with renal calculi less than 20 mm will be managed by flexible ureteroscopy. at the end of the procedure, they will be randomized to receive either temporary ureteral catheter for 2 days or indweeling double J stent for 2-4 weeks

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Amr Abdel-Lateif El-Sawy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr A Elsawy

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Urology and Nephrology Center

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

AE 201121

Identifier Type: -

Identifier Source: org_study_id