Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-03-28
2020-05-31
Brief Summary
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Detailed Description
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Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.
This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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conventional
this arm will have both nephrostomy tube and ureteric catheter after completing the operation
percutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
tubeless
the arm will have only ureteric catheter rafter completing the operation
percutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
Interventions
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percutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3\. Complex or staghorn stones requiring staged procedure.
Intra operative criteria:
4\. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
18 Years
55 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamed Ahmed Alsayed Ahmed Zowita
principal investigator
Principal Investigators
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atef abd aziz, professor
Role: STUDY_CHAIR
assuit university hospital urology departement egypt
Locations
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Assuit University Hospitals
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Valdivia 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.
Other Identifiers
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tubeless PCNL
Identifier Type: -
Identifier Source: org_study_id
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