Conventional PCNL Versus Tubeless PCNL

Assiut University

Status: Unknown

Conditions: Percutaneous Nephrolithotomy

Treatments: Procedure: percutaneous nephrolithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03907930

tubeless PCNL

Details and patient eligibility

About

prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

conventional

Active Comparator group

Description:

this arm will have both nephrostomy tube and ureteric catheter after completing the operation

Treatment:

Procedure: percutaneous nephrolithotripsy

tubeless

Active Comparator group

Description:

the arm will have only ureteric catheter rafter completing the operation

Treatment:

Procedure: percutaneous nephrolithotripsy