Mini- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy for High Density Renal Stones

NCT04346134 | Completed

• 1 other identifier: Uro_Azhar_16_019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies were conducted to compare extracorporeal shockwave lithotripsy (SWL) and percutaneous nephrolithotomy (PNL) as treatment options for medium size lower caliceal high dense stones. However, no studies compared these options for non- lower polar stones. In the present study the investigators will compare mini-PNL and SWL in treatment of non- lower polar, medium size, high dense renal stones in reference to the stone free rate and safety of the procedures. Pre-operative evaluation including abdominal non-contrasted computed tomography will be performed for all patients. Patients will be randomly allocated into two equal groups and will be treated by either mini-PNL or SWL. postoperative, patients will be followed by regularly for 3 months. the outcome of the procedures will be evaluated and compared between groups.

Conditions

Renal Stone; Extracorporeal Shockwave Lithotripsy; Percutaneous Nephrolithotomy

Outcome Measures

Primary Outcomes (1)

• Stone Free Rate

  No residual renal stone or residual fragment(s) less than 4 mm size

  as detected by non-contrasted computed tomography 3 months after the intervention procedures.

Secondary Outcomes (1)

• Complications

  Intra- and 3 months post-operative complications

Study Arms (2)

mini-PNL group

EXPERIMENTAL

In which percutaneous nephrolithotomy will be performed using miniature nephroscope.

Procedure: mini-PNL

SWL group

EXPERIMENTAL

In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII

Procedure: SWL

Interventions

mini-PNL PROCEDURE

Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.

mini-PNL group

SWL PROCEDURE

Extracorporal shockwave lithotripsy using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.

SWL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with high density (\>1000 HU), non-lower polar, single renal stone of 10 to 20 mm size

You may not qualify if:

• Pregnant women, morbid obesity, severe orthopaedic deformities, any co-morbidities precluding general anaesthesia or prone positioning, uncorrectable coagulation disorders, active urinary tract infection (UTI), stone in calyceal diverticulum, abnormal renal anatomy and urinary tract obstruction distal to the stone

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Andrology

Model Details: Double-arm, prospective, Randomized, intervention study

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: July 14, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

EG (1)