Percutaneous Nephrolithotomy
Conditions
Brief summary
prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL
Detailed description
Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications. 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
Interventions
PROCEDUREpercutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
triple blinded study
Intervention model description
group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure
Exclusion criteria
1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of days of hospital stay for both groups | 15 days | comparison between number of days in hospital for both groups |
| dose of analgesia used to control pain after the procedure | 5 days | comparison between the dose of analgesia needed for both groups in milligram |
Countries
Egypt
Contacts
Primary Contactmohamed zowita, doctor
Backup Contactmahmoud shalaby, professor
Outcome results
None listed