Conventional PCNL Versus Tubeless PCNL
Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
1 other identifier
interventional
60
1 country
1
Brief Summary
prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL
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 Mar 2019
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
March 28, 2019
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedApril 9, 2019
April 1, 2019
1 year
March 28, 2019
April 8, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
number of days of hospital stay for both groups
comparison between number of days in hospital for both groups
15 days
dose of analgesia used to control pain after the procedure
comparison between the dose of analgesia needed for both groups in milligram
5 days
Study Arms (2)
conventional
ACTIVE COMPARATORthis arm will have both nephrostomy tube and ureteric catheter after completing the operation
tubeless
ACTIVE COMPARATORthe arm will have only ureteric catheter rafter completing the operation
Interventions
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
Eligibility Criteria
You may qualify if:
- Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure
You may not qualify if:
- Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.
- \. Complex or staghorn stones requiring staged procedure.
- Intra operative criteria:
- \. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit University Hospitals
Asyut, Egypt
Related Publications (2)
Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
PMID: 1006190BACKGROUNDValdivia Uria JG, Valle Gerhold J, Lopez Lopez JA, Villarroya Rodriguez S, Ambroj Navarro C, Ramirez Fabian M, Rodriguez Bazalo JM, Sanchez Elipe MA. Technique and complications of percutaneous nephroscopy: experience with 557 patients in the supine position. J Urol. 1998 Dec;160(6 Pt 1):1975-8. doi: 10.1016/s0022-5347(01)62217-1.
PMID: 9817303BACKGROUND
Study Officials
- STUDY CHAIR
atef abd aziz, professor
assuit university hospital urology departement egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- triple blinded study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 9, 2019
Study Start
March 28, 2019
Primary Completion
April 1, 2020
Study Completion
May 1, 2020
Last Updated
April 9, 2019
Record last verified: 2019-04