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

Not Applicable
Active, not recruiting
Conditions
Stones, Kidney
Interventions
Procedure: Flexible ureteroscopy for renal calculi less than 20 mm
Registration Number
NCT04643145
Lead Sponsor
Mansoura University
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
130
Inclusion Criteria
  • 1- Adult patients (aged >18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ureteral catheterFlexible ureteroscopy for renal calculi less than 20 mmThis group will receive ureteral catheter for 2 days after the procedure
Indwelling double J stentFlexible ureteroscopy for renal calculi less than 20 mmThis group will receive indwelling double J stent for 2-4 weeks after the procedure
Primary Outcome Measures
NameTimeMethod
Stone free rate12 weeks after the procedure

presence of residual fragments on non contrast computed tomography

Secondary Outcome Measures
NameTimeMethod
perioperative complicationsFirst 3 days postoperative

perioperative complications after the procedure

Postoperative pain by visual analogue scalefirst 24 hours postoperatively

Visual analogue scale will be assessed postoperative

Trial Locations

Locations (1)

Urology and Nephrology Center

🇪🇬

Mansoura, DK, Egypt

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