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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04643145
Enrollment
130
Registered
2020-11-24
Start date
2020-03-01
Completion date
2024-12-15
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stones, Kidney

Keywords

Kidney stones, Flexible ureteroscopy, Quality of life, drainage

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.

Interventions

PROCEDUREFlexible 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stone free rate12 weeks after the procedurepresence of residual fragments on non contrast computed tomography

Secondary

MeasureTime frameDescription
perioperative complicationsFirst 3 days postoperativeperioperative complications after the procedure
Postoperative pain by visual analogue scalefirst 24 hours postoperativelyVisual analogue scale will be assessed postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026