Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- dose of analgesia used to control pain after the procedure
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
triple blinded study
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients above 18 years old
- •Patients with any stone burden and stone number requiring single procedure
Exclusion Criteria
- •1 - Patients aged below 18 years old.
- •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.
- •Significant intraoperative bleeding.
- •Intraoperative pelvi calyceal system perforation.
- •Residual stones necessitate 2nd look PNL
Arms & Interventions
conventional
this arm will have both nephrostomy tube and ureteric catheter after completing the operation
Intervention: percutaneous nephrolithotripsy (Procedure)
tubeless
the arm will have only ureteric catheter rafter completing the operation
Intervention: percutaneous nephrolithotripsy (Procedure)
Outcomes
Primary Outcomes
dose of analgesia used to control pain after the procedure
Time Frame: 5 days
comparison between the dose of analgesia needed for both groups in milligram
number of days of hospital stay for both groups
Time Frame: 15 days
comparison between number of days in hospital for both groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Ahmed Alsayed Ahmed Zowita
principal investigator
Assiut University