The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique in PCNL
1 other identifier
interventional
60
1 country
1
Brief Summary
To analyze and compare the puncture success rate, puncture fluoroscopy time and intraoperative puncture complications of two different puncture techniques; fluoroscopic bi-planar (0-30º) versus newly reported bi-planar (0-90º) technique in PCNL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedStudy Start
First participant enrolled
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJune 3, 2022
June 1, 2022
11 months
September 15, 2020
June 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The puncture success rate and number of attempts
percentage of patients in whom the renal puncture achieving desired calyx (evaluated by adequate introduction of the guidewire, bright urine output and stone accessibility).
intraoperative
Secondary Outcomes (2)
The Puncture fluoroscopy screening time
intraoperative
Intraoperative puncture complications
intraoperative
Study Arms (2)
Group 1: 0-30° technique.
ACTIVE COMPARATORProcedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
Group 2: new 0-90° technique.
ACTIVE COMPARATORProcedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
Interventions
after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-30 degree technique of C-Arm.
after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-90 degree technique of C-Arm.
Eligibility Criteria
You may qualify if:
- A patient over 18 years old.
- Renal stone 2 cm or greater.
You may not qualify if:
- A patient \< 18 years old.
- Congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney.
- Patient with obvious spinal deformity.
- Coagulopathies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MenoufiaU
Menoufia, Shebin El-kom, 32511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed Elshazly, MD
Menoufia University
- STUDY DIRECTOR
Mohamed Kamal Omar, MD
Menoufia University
- STUDY DIRECTOR
Eid El Sherif, MD
Menoufia University
- STUDY DIRECTOR
Mohamed Aziz, MD
Menoufia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 22, 2020
Study Start
May 24, 2021
Primary Completion
April 17, 2022
Study Completion
May 1, 2022
Last Updated
June 3, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share