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RIRS for Treatment of Stones in Congenital Anomalous Kidneys

Primary Purpose

Renal Calculi, Renal Anomaly

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
RIRS
SWL
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculi

Eligibility Criteria

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

Inclusion Criteria:

  • The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.

Exclusion Criteria:

  • Pregnant women.
  • Uncorrectable coagulation disorders.
  • Urinary tract obstruction distal to the stone.
  • Active infection.
  • Stone in a calyceal diverticulum

Sites / Locations

  • Urology Department, Al-Azhar University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RIRS group

SWL group

Arm Description

The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure.

The medical records of all patients who underwent SWL at our institution in the past five years will be reviewed. Patients with renal rotation or position anomalies, as defined by NCCT and/or IVU, will be included for possible study participation.

Outcomes

Primary Outcome Measures

Stone-free rate
Stone-free status is defined as no residual fragments of ≥3 mm on abdominal NCCT and/or X-ray KUB.

Secondary Outcome Measures

Complication rate
intraoperative and postoperative complications
operative time
from starting till the end of the procedure
Re-treatment rate
need for reintervention

Full Information

First Posted
February 4, 2022
Last Updated
April 22, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05240170
Brief Title
RIRS for Treatment of Stones in Congenital Anomalous Kidneys
Official Title
Retrograde Intrarenal Surgery for Treatment of Stones in Congenital Anomalous Kidneys: Case Matched Comparative Study With Extracorporeal Shockwave Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (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
The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.
Detailed Description
In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi, Renal Anomaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 1st group: RIRS The 2nd group: SWL
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIRS group
Arm Type
Experimental
Arm Description
The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure.
Arm Title
SWL group
Arm Type
Experimental
Arm Description
The medical records of all patients who underwent SWL at our institution in the past five years will be reviewed. Patients with renal rotation or position anomalies, as defined by NCCT and/or IVU, will be included for possible study participation.
Intervention Type
Device
Intervention Name(s)
RIRS
Other Intervention Name(s)
Retrograde flexible ureteroscopy
Intervention Description
The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure.
Intervention Type
Device
Intervention Name(s)
SWL
Intervention Description
Patients who underwent SWL at our institution in the past five years. According to (a) the type of renal anomaly (rotation, position, or rotation/position anomaly), (b) the size of the stone (±5 mm), (c) location of the stone (lower polar or non-lower polar), and (d) density of the stone (>800 HU or ≤800 HU), matched cases will be selected for comparison.
Primary Outcome Measure Information:
Title
Stone-free rate
Description
Stone-free status is defined as no residual fragments of ≥3 mm on abdominal NCCT and/or X-ray KUB.
Time Frame
3-months after the intervention.
Secondary Outcome Measure Information:
Title
Complication rate
Description
intraoperative and postoperative complications
Time Frame
intraoperative till 3 months postoperative complications
Title
operative time
Description
from starting till the end of the procedure
Time Frame
the procedure time
Title
Re-treatment rate
Description
need for reintervention
Time Frame
during the post-operative 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies. Exclusion Criteria: Pregnant women. Uncorrectable coagulation disorders. Urinary tract obstruction distal to the stone. Active infection. Stone in a calyceal diverticulum
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abul-fotouh Ahmed, MD
Phone
00201001066756
Email
abulfotouhahmed@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abul-fotouh Ahmed, MD
Organizational Affiliation
Al-Azhar University Hospitals, Cairo, Egypt
Official's Role
Principal Investigator
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
First Name & Middle Initial & Last Name & Degree
Mohammed Raafat

12. IPD Sharing Statement

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RIRS for Treatment of Stones in Congenital Anomalous Kidneys

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