Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial
Primary Purpose
Urolithiasis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Basketing in RIRS
Dusting in RIRS
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring RIRS, Renal stones, Efficacy, Safety
Eligibility Criteria
Inclusion Criteria:
- Patients must be a suitable operative candidate for RIRS
- Age ≥18 years
- Normal renal function
- ASA score Ⅰ and Ⅱ
- Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Exclusion Criteria:
- Pregnant subjects
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
- Patients who underwent transplant or urinary diversion.
- Congenital abnormalities.
Sites / Locations
- Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dusting
Basketing
Arm Description
small stones will be left to pass spontaneously.
stones will be actively extracted.
Outcomes
Primary Outcome Measures
Stone free rate (SFR)
To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist or uric acid it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient.
Secondary Outcome Measures
Operating time
from starting fragmentation to placement of stent (DJ stent or ureteral stent) unless no stent is needed
Complication rates
Complication such as fever, pain, urosepsis etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03207659
Brief Title
Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial
Official Title
Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guohua Zeng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.
Detailed Description
RIRS has been widely adopted and used by urologists worldwide in the management of renal stones due to less invasiveness and efficacy, especially in small to moderate-sized renal stones. RIRS has several advantages over SWL for stones less than 2 cm diameter. Most importantly, removing the stone in one session without the need for other treatment modalities.
Furthermore, the application of RIRS has expanded to larger stones reaching up to 35 mm in some cases,in spite of not being the first line therapy for the larger stones. RIRS has advantages over the PCNL especially concerning complications. Namely lower or no bleeding events and the less invasiveness of RIRS.
Options for the treatment of intrarenal stones include fragmenting the stone then extracting large fragments using a basket or dusting the stone into very small fragments then leaving the (dust) to pass spontaneously.
The idea of dusting in RIRS emerges as a counterpart of the originally taught fragmentation and basketing of the stones. Aiming to reduce multiple entries and exits for the renal system and ultimately not requiring UAS or baskets during the surgery. Thus theoretically decreasing operative time and costs with the same SFRs, In addition to minimizing the risk of ureteral injury .
So there is a debate amongst surgeons whether to laser the stone to dust or fragment and retrieve intra-renal fragments. EAU guidelines on the surgical management of urolithiasis stated that dusting strategies should be limited to the treatment of large renal stones. Without clearly differentiating between dusting or fragmentation and basketing. Cho et al; favored fragmentation technique especially for large renal stones because the dust in dusting technique may affect visualization and obscure small stone fragments. But this was an opinion and not built on a direct comparative study.
Until now, there is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. And to date, no prospective randomized study has addressed the practice of active extraction vs. spontaneous passage
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
RIRS, Renal stones, Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dusting
Arm Type
Experimental
Arm Description
small stones will be left to pass spontaneously.
Arm Title
Basketing
Arm Type
Experimental
Arm Description
stones will be actively extracted.
Intervention Type
Procedure
Intervention Name(s)
Basketing in RIRS
Intervention Description
Treament of renal stones by fragmentation of stone under direct vision through a flexible ureteroscope and then actively extracting them using a basket
Intervention Type
Procedure
Intervention Name(s)
Dusting in RIRS
Intervention Description
Treament of renal stones by dusting the stone under direct vision through a scope and then leaving them to pass spontaneously
Primary Outcome Measure Information:
Title
Stone free rate (SFR)
Description
To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist or uric acid it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient.
Time Frame
4-6 weeks after surgery
Secondary Outcome Measure Information:
Title
Operating time
Description
from starting fragmentation to placement of stent (DJ stent or ureteral stent) unless no stent is needed
Time Frame
intraoperatively
Title
Complication rates
Description
Complication such as fever, pain, urosepsis etc.
Time Frame
intraoperatively or 48h postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be a suitable operative candidate for RIRS
Age ≥18 years
Normal renal function
ASA score Ⅰ and Ⅱ
Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Exclusion Criteria:
Pregnant subjects
Uncorrected coagulopathy and active urinary tract infection (UTI)
prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
Patients who underwent transplant or urinary diversion.
Congenital abnormalities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, Ph.D and M.D.
Phone
+86 13802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Cai, PH.D & MD
Phone
+86 13512780911
Email
673059209@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, PH.D & MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD.
Phone
+86 13802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD.
First Name & Middle Initial & Last Name & Degree
Chao Cai, PH.D & MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial
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