Endoscopic Guided PCNL Versus Standard PCNL
Primary Purpose
Stones, Kidney
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic compbined guided PCNL
Standard PCNL
Sponsored by
About this trial
This is an interventional treatment trial for Stones, Kidney
Eligibility Criteria
Inclusion Criteria:
- patients with renal stones diameter of at least 2 cm.
- American Society of Anesthesiology score ≤ 2.
Exclusion Criteria:
- patients with renal anomalies.
- transplanted kidney.
- uncorrected coagulopathy.
- active infection.
Sites / Locations
- Banha university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ECIRS-Group
SPCNL-GRoup
Arm Description
Outcomes
Primary Outcome Measures
Stone Free Rate
If their is any residual stones
Stone Free Rate
If their is any residual stones
Stone Free Rate
If their is any residual stones
Secondary Outcome Measures
operative time
the length of operation
blood loss
hemoglobin drop
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04825353
Brief Title
Endoscopic Guided PCNL Versus Standard PCNL
Official Title
Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.
the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .
Detailed Description
Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.
patients & methods: Patients will randomly be divided into two equal groups:
Group A: Patient will undergo ECIRS.
Group B: Patient will undergo standard PCNL
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stones, Kidney
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ECIRS-Group
Arm Type
Experimental
Arm Title
SPCNL-GRoup
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic compbined guided PCNL
Intervention Description
patient undergo stone removal by ECIRS
Intervention Type
Procedure
Intervention Name(s)
Standard PCNL
Intervention Description
patient undergo SPCNL
Primary Outcome Measure Information:
Title
Stone Free Rate
Description
If their is any residual stones
Time Frame
1day after operation.
Title
Stone Free Rate
Description
If their is any residual stones
Time Frame
1 months post operative
Title
Stone Free Rate
Description
If their is any residual stones
Time Frame
3 months post-operative
Secondary Outcome Measure Information:
Title
operative time
Description
the length of operation
Time Frame
intra oprative
Title
blood loss
Description
hemoglobin drop
Time Frame
pre-operative and 1 day post-oprative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with renal stones diameter of at least 2 cm.
American Society of Anesthesiology score ≤ 2.
Exclusion Criteria:
patients with renal anomalies.
transplanted kidney.
uncorrected coagulopathy.
active infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed El-Shaer, M.D
Phone
01015767331
Ext
0020
Email
waleed_elshaer@hotmail.com
Facility Information:
Facility Name
Banha university hospital
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Endoscopic Guided PCNL Versus Standard PCNL
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