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Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

Primary Purpose

Kidney Stone, Retrograde Intrarenal Surgery, Ureteral Stent

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Retrograde intrarenal surgery with external ureteral catheter
Retrograde intrarenal surgery with double J internal ureteral stent
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

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

Inclusion Criteria: • Adult patients of either gender in whom RIRS was the primary modality. Exclusion Criteria: Pregnant women Active urinary tract infection solitary kidney Concomitant pathology that need intervention in the same setting Patients with surgical incidents that indicate double-J stenting (Residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).

Sites / Locations

  • Urology Department, Al-Azhar University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

External Ureteral Catheter group

Double J group

Arm Description

After RIRS, an external ureteral catheter will be placed for one day.

After RIRS, a double J internal ureteral stent will be placed for 2 weeks.

Outcomes

Primary Outcome Measures

Stone free rate
No stones or residual fragments >3 mm on postoperative imaging study
Stent-related symptoms
Irritative lower urinary tract symptoms

Secondary Outcome Measures

Postoperative renal pain
Renal pain attacks and severity as evaluated by visual analogue pain scale (VAPS). The VAPS is a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Rehospitalization rate
the need for unscheduled hospital admission
Reintervention rate
the need for reoperation

Full Information

First Posted
February 11, 2023
Last Updated
April 16, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05738304
Brief Title
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones
Official Title
One-Day External Ureteral Catheter Versus Double-J Internal Ureteral Stent After Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar 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
Several studies evaluated the benefit of a short-term external ureteral catheter (UC) compared to double-J (DJ) ureteral stent after flexible ureteroscopy (URS); the results were controversial. These studies had combined analyses of ureteral and renal stones with a high risk of selection bias. Studies comparing external UC and DJ stent after flexible URS for isolated renal stones are lacking. In the present study, the investigators will compare the outcomes of using a one-day external UC versus a DJ internal ureteral stent for ureteral drainage after retrograde flexible URS (retrograde intrarenal surgery "RIRS") for renal stones. The investigators aim to identify the best ureteral drainage method after RIRS regarding stone clearance, complications, and stent-related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Retrograde Intrarenal Surgery, Ureteral Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External Ureteral Catheter group
Arm Type
Experimental
Arm Description
After RIRS, an external ureteral catheter will be placed for one day.
Arm Title
Double J group
Arm Type
Active Comparator
Arm Description
After RIRS, a double J internal ureteral stent will be placed for 2 weeks.
Intervention Type
Procedure
Intervention Name(s)
Retrograde intrarenal surgery with external ureteral catheter
Intervention Description
The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, an external ureteral catheter will be placed for 24 hours.
Intervention Type
Procedure
Intervention Name(s)
Retrograde intrarenal surgery with double J internal ureteral stent
Intervention Description
The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, a double-J internal ureteric stent will be placed for 2 weeks.
Primary Outcome Measure Information:
Title
Stone free rate
Description
No stones or residual fragments >3 mm on postoperative imaging study
Time Frame
up to 1 month
Title
Stent-related symptoms
Description
Irritative lower urinary tract symptoms
Time Frame
from post operative day one till double J removal; an average of 2 weeks
Secondary Outcome Measure Information:
Title
Postoperative renal pain
Description
Renal pain attacks and severity as evaluated by visual analogue pain scale (VAPS). The VAPS is a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame
up to 1 month
Title
Rehospitalization rate
Description
the need for unscheduled hospital admission
Time Frame
From post RIRS home discharge up to one month
Title
Reintervention rate
Description
the need for reoperation
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Adult patients of either gender in whom RIRS was the primary modality. Exclusion Criteria: Pregnant women Active urinary tract infection solitary kidney Concomitant pathology that need intervention in the same setting Patients with surgical incidents that indicate double-J stenting (Residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abul-fotouh Ahmed, MD
Phone
00201001066756
Email
abulfotouhahmed@yahoo.com
Facility Information:
Facility Name
Urology Department, Al-Azhar University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Fahim, MD
Phone
002025107333
Email
urologyhospital@gmail.com

12. IPD Sharing Statement

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Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

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