Clinical trial NCT03907930: Conventional PCNL Versus Tubeless PCNL
Official title: Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Nephrolithotomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: number of days of hospital stay for both groups
timeFrame: 15 days
measure: dose of analgesia used to control pain after the procedure
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University Hospitals
Study officials:
affiliation: assuit university hospital urology departement egypt
name: atef abd aziz, professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.