The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones
1 other identifier
interventional
240
1 country
1
Brief Summary
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
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
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 29, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedAugust 9, 2017
July 1, 2017
1.5 years
July 29, 2017
August 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stone free rate three months after the last session
residual less than 4 mm by non-contrast computerized tomography scan (NCCT)
18 months
Secondary Outcomes (1)
severity of complications after SWL in both groups
18 months
Study Arms (2)
Bidirectional Shock Wave Lithotripsy
ACTIVE COMPARATORalternating bidirectional (under and over table) approach
Standard Shock Wave Lithotripsy
ACTIVE COMPARATORstandard unidirectional approach
Interventions
the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones
the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones
Eligibility Criteria
You may qualify if:
- Patient criteria:
- Ability to give informed consent.
- Normal laboratory profile as regarding serum creatinine, liver function, platelets count and prothrombin time.
- Stone criteria:
- Single renal stone less than two cm or upper lumbar ureteric stone less than one cm.
- Radio-opaque stones.
You may not qualify if:
- Bleeding tendency.
- Poor kidney function.
- Pregnancy.
- Abdominal aortic aneurysm.
- Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN).
- Congenital anomalies of the urinary tract.
- Untreated urinary tract infection.
- Obstructed urinary tract distal to the stone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology center
Al Mansurah, 35516, Egypt
Related Publications (1)
Hegazy M, El-Assmy A, Ali-El-Dein B, Sheir KZ. The alternating bidirectional versus the standard approach during shock wave lithotripsy for upper lumbar ureteric stones: a randomized controlled trial. World J Urol. 2021 Jan;39(1):247-253. doi: 10.1007/s00345-020-03148-5. Epub 2020 Mar 23.
PMID: 32206888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- MD
Study Record Dates
First Submitted
July 29, 2017
First Posted
August 9, 2017
Study Start
September 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
August 9, 2017
Record last verified: 2017-07