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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

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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
November 21, 2020
Last Updated
April 8, 2023
Sponsor
Mansoura University
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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

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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

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