Conventional PCNL Versus Tubeless PCNL

Percutaneous Nephrolithotomy Clinical Trial

Official title:

Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907930
• Other study ID #: tubeless PCNL
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: May 2020

Study information

• Verified date: April 2019
• Source: Assiut University
• Contact: mohamed zowita, doctor
• Phone: 01006769102
• Email: maaszo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

Procedure:
• percutaneous nephrolithotripsy
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast

Locations

Country	Name	City	State
Egypt	Assuit University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Fernström I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. — View Citation

Valdivia Uría JG, Valle Gerhold J, López López JA, Villarroya Rodriguez S, Ambroj Navarro C, Ramirez Fabián M, Rodriguez Bazalo JM, Sánchez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days of hospital stay for both groups	comparison between number of days in hospital for both groups	15 days
Primary	dose of analgesia used to control pain after the procedure	comparison between the dose of analgesia needed for both groups in milligram	5 days