Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04643145
Other study ID # AE 201121
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date December 15, 2024

Study information

Verified date April 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 130
Est. completion date December 15, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Urology and Nephrology Center Mansoura DK

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone free rate presence of residual fragments on non contrast computed tomography 12 weeks after the procedure
Secondary perioperative complications perioperative complications after the procedure First 3 days postoperative
Secondary Postoperative pain by visual analogue scale Visual analogue scale will be assessed postoperative first 24 hours postoperatively
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03243682 - The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones N/A
Recruiting NCT04825353 - Endoscopic Guided PCNL Versus Standard PCNL N/A
Not yet recruiting NCT05299996 - Flexible URS in Management of Renal Stones in Anomalous Kidney N/A