Conventional PCNL Versus Tubeless PCNL

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

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

Study Overview

• Status: Unknown
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Procedure: percutaneous nephrolithotripsy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed zowita, doctor; Phone Number: 01006769102; Email: maaszo@gmail.com
• Study Contact Backup: Name: mahmoud shalaby, professor; Phone Number: 01111222203; Email: shalabyjunior@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assuit University hospitals
    • Contact: mohamed zowita, doctor; Phone Number: 01006769102; Email: maaszo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional; this arm will have both nephrostomy tube and ureteric catheter after completing the operation	Procedure: percutaneous nephrolithotripsy; removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast; Other Names: PCNL
Active Comparator: tubeless; the arm will have only ureteric catheter rafter completing the operation	Procedure: percutaneous nephrolithotripsy; removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast; Other Names: PCNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days of hospital stay for both groups	comparison between number of days in hospital for both groups	15 days
dose of analgesia used to control pain after the procedure	comparison between the dose of analgesia needed for both groups in milligram	5 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: atef abd aziz, professor, assuit university hospital urology departement egypt

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: tubeless PCNL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No