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Clinical Trials/NCT04643145
NCT04643145
Active, not recruiting
Not Applicable

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

Mansoura University1 site in 1 country130 target enrollmentMarch 1, 2020
ConditionsStones, Kidney

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stones, Kidney
Sponsor
Mansoura University
Enrollment
130
Locations
1
Primary Endpoint
Stone free rate
Status
Active, not recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Abdel-Lateif El-Sawy

Principal Investigator

Mansoura University

Eligibility Criteria

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)

Study Sites (1)

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