Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Primary Purpose
Stones, Kidney
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flexible ureteroscopy for renal calculi less than 20 mm
Sponsored by
About this trial
This is an interventional treatment trial for Stones, Kidney focused on measuring Kidney stones, Flexible ureteroscopy, Quality of life, drainage
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
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ureteral catheter
Indwelling double J stent
Arm Description
This group will receive ureteral catheter for 2 days after the procedure
This group will receive indwelling double J stent for 2-4 weeks after the procedure
Outcomes
Primary Outcome Measures
Stone free rate
presence of residual fragments on non contrast computed tomography
Secondary Outcome Measures
perioperative complications
perioperative complications after the procedure
Postoperative pain by visual analogue scale
Visual analogue scale will be assessed postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04643145
Brief Title
Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Official Title
Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stones, Kidney
Keywords
Kidney stones, Flexible ureteroscopy, Quality of life, drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ureteral catheter
Arm Type
Active Comparator
Arm Description
This group will receive ureteral catheter for 2 days after the procedure
Arm Title
Indwelling double J stent
Arm Type
Active Comparator
Arm Description
This group will receive indwelling double J stent for 2-4 weeks after the procedure
Intervention Type
Procedure
Intervention Name(s)
Flexible ureteroscopy for renal calculi less than 20 mm
Intervention Description
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
Primary Outcome Measure Information:
Title
Stone free rate
Description
presence of residual fragments on non contrast computed tomography
Time Frame
12 weeks after the procedure
Secondary Outcome Measure Information:
Title
perioperative complications
Description
perioperative complications after the procedure
Time Frame
First 3 days postoperative
Title
Postoperative pain by visual analogue scale
Description
Visual analogue scale will be assessed postoperative
Time Frame
first 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Elsawy
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
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