Modified Supine vs Prone Position Pnl
1 other identifier
observational
200
1 country
1
Brief Summary
perform a comparative randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions in management of complex renal stones
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
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
May 10, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMay 18, 2022
May 1, 2022
3 years
May 10, 2022
May 14, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
number of participants completely stone-free
4 years
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
measure amount of blood loss
4 years
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
measure of Time of operation
4 years
Study Arms (2)
group (1 ) Modified Supine
Modified Supine position PNL
group (2) prone
Prone position PNL
Interventions
Extraction of kidney stones through skin using nephroscope
Eligibility Criteria
All adult patients with renal stones candidate for operation
You may qualify if:
- Grade II - A solitary stone in the upper pole with simple anatomy or multiple stones in a patient with simple anatomy or any solitary stone in a patient with abnormal anatomy
- Grade III - Multiple stones in a patient with abnormal anatomy or, stones in a calyceal diverticulum or partial staghorn calculus
- Grade IV - Staghorn calculus or any stone in a patient with spina bifida or spinal injury.
You may not qualify if:
- · Pediatric group
- Grade I - A solitary stone in the mid/lower pole with simple anatomy or a solitary stone in the pelvis with simple anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit facility of medicine
Asyut, Assuit, Egypt
Related Publications (2)
Gokce MI, Ibis A, Sanci A, Akinci A, Bagci U, Agaoglu EA, Suer E, Gulpinar O. Comparison of supine and prone positions for percutaneous nephrolithotomy in treatment of staghorn stones. Urolithiasis. 2017 Dec;45(6):603-608. doi: 10.1007/s00240-017-0977-y. Epub 2017 Mar 29.
PMID: 28357451RESULTMcCahy P, Rzetelski-West K, Gleeson J. Complete stone clearance using a modified supine position: initial experience and comparison with prone percutaneous nephrolithotomy. J Endourol. 2013 Jun;27(6):705-9. doi: 10.1089/end.2012.0650. Epub 2013 Mar 18.
PMID: 23363334RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
May 10, 2022
First Posted
May 18, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share