Ultra-Mini Versus Standard Percutaneous Nephrolithotomy For Management Of Renal Calculi. A Randomized Controlled Trial.

Phase 3

• Conditions: Stone, Kidney
• Interventions: Procedure: percutaneous nephrolithotomy; Procedure: ultra-mini percutaneous nephrolithotomy

• Registration Number: NCT04764071
• Lead Sponsor: Ain Shams University

Brief Summary

Renal stones are one of the most common urological problems and there are multiple methods for their management such as percutaneous nephrolithotomy, mini and ultra-mini percutaneous nephrolithotomy, flexible ureteroscopy and laser lithotripsy, and extracorporeal shock wave lithotripsy. percutaneous nephrolithotomy is the treatment of choice for the management of renal calculi, in spite of the increasing stone clearance rate, the complication rate of this procedure is relatively higher.

Detailed Description

Nephrolithiasis is a major worldwide source of morbidity, constituting a common urological disease affecting 10-15% of the world population. Consistent technical advancements provide surgeons and patients with several options for the treatment of renal calculi, including extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and conventional open surgery.

Percutaneous nephrolithotomy (PCNL) is generally considered a gold standard in renal stones particularly larger than 2cm or lower calyceal larger than 1cm offering high stone-free rates after the first treatment as compared to the other minimal invasive lithotripsy techniques.

Percutaneous nephrolithotripsy (PCNL)is a procedure to remove kidney stones from the kidney through a small incision in the skin and it was initially described in the literature by Fernström and Johansson in 1976. Traditionally, the prone position was considered the only position to obtain renal access for PCNL. In 1987, Valdivia Urìa presented the supine PCNL.

PCNL is also recommended in the case of smaller stones in patients with contraindications for shockwave lithotripsy (SWL), such as shockwave resistant stones and anatomical malformations, or when a patient elects PCNL as a procedure of higher efficacy. However, serious complications although rare should be expected following this percutaneous procedure as, Perioperative bleeding, urine leakage from nephrocutaneous tract, pelvicalyceal system injury, pain.( Kyriazis et al 2015) colon injury, hydrothorax, pneumothorax, prolonged leak, sepsis, ureteral stone, vascular injury and acute loss of kidney, all are individually confronted complications after PCNL.

PCNL techniques include: standard PCNL (S-PCNL), mini-PCNL (also called miniperc), ultra-mini-PCNL (UM-PCNL) and the recently introduced micro-PCNL. One of the most important differences between the various PCNL techniques is the size of renal access, which contributes to the broad spectrum of complications and outcomes.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Study Start: 2021-02-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patient aged over 18 with renal stone between 1 and 2 cm

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Exclusion Criteria

1. patient with a single kidney.
2. Renal stones larger than 2 cm or less than 1 cm.
3. Patients with uncontrolled co-morbidities (hypertension, diabetes mellitus, cardiac disease, chest disease).
4. Patients with active urinary tract infection.
5. Patients with other anatomic renal abnormalities (congenital renal malformations such as horseshoe kidney, polycystic kidney disease, etc.). and Patients with severe skeletal deformity.
6. Pregnant women.
7. Patients with Uncorrectable bleeding disorder.
8. Patients who underwent renal transplantation or urinary diversion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous nephrolithotomy	percutaneous nephrolithotomy	Patients are positioned in the lithotomy position and a 6F ureteral catheter is placed and the bladder is drained with a 16F urethral Foley catheter. After ureteral catheterization, patients are placed in the prone position, and percutaneous access of the desired calyx is achieved under fluoroscopic guidance with the use of an 18-gauge needle and a guidewire passage. Tract dilation is accomplished by using Amplatz dilators up to 30F. Pneumatic lithotripter is used for fragmentation and stone removal is accomplished with retrieval graspers through a rigid 22F nephroscope. An 18-24 F nephrostomy tube is placed at the end of the operation.
ultra-mini percutaneous nephrolithotomy	ultra-mini percutaneous nephrolithotomy	Patients are positioned in the lithotomy position and a 6 F ureteral catheter is placed and the bladder is drained with a 16F urethral Foley catheter. After ureteral catheterization, patients are placed in the prone position, and percutaneous access of the desired calyx is achieved under fluoroscopic guidance with the use of an 18-gauge needle and a guidewire passage. Tract dilation is accomplished by using Amplatz dilators up to 12-14 F fascial dilator was used to dilate the nephrostomy tract to pass the 13 F semi-rigid plastic sheath. Then, a 9.5-F, rigid ureteroscope (KARL STORZ Medical Instruments) was introduced to the sheath. The renal stones were broken into pieces using holmium laser lithotripsy. Finally, the ureteroscope and sheath were removed and the tract site was packed for 2-3 min. then placement of double J stent will be done according to the decision of the operating surgeon for 3 to 4 weeks.

Primary Outcome Measures

Name	Time	Method
stone free rate of patients with renal stones by non contrast CT scan	first day postoperative	efficacy of the procedure to clear renal stones completely in single session, non contrast CT will evaluate the stone burden and compare it to the preoperative measurement

Secondary Outcome Measures

Name	Time	Method
operative time of both procedures	intraoperative finding	time of each procedure in minutes from the lithotomy positioning till completion of the procedure
hospital stay of the patient	1 to 3 days postoperative	duration till patient is discharged in days
hemoglobin drop of the patients	first day postoperative	decrease in the hemoglobin level in comparison to the preoperative results
cost analysis of both procedure	3 days postoperative	cost of each procedure including operative cost and postoperative stay in Egyptian Pound
postoperative urine leakage from the surgical wound	first day postoperative	urine leakage from the nephrostomy site if it present or not as document during surgical dressing by the attending physician

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt