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

Stone, Kidney Clinical Trial

Official title:

Safety And Efficacy Of Ultra-Mini Percutaneous Nephrolithotomy In Comparison With Standard Percutaneous Nephrolithotomy For Management Of Renal Calyceal Calculi 1 Cm To 2 Cm In Size. Comparative Randomized Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764071
• Other study ID #: MD 06 /2020
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: Ashraf Satour, Master degree of Urology
• Phone: 01000396284
• Email: ahsrafsatour[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Stone, Kidney

Intervention

Procedure:
• percutaneous nephrolithotomy
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.
• ultra-mini percutaneous nephrolithotomy
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.

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate of patients with renal stones by non contrast CT scan	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	first day postoperative
Secondary	operative time of both procedures	time of each procedure in minutes from the lithotomy positioning till completion of the procedure	intraoperative finding
Secondary	hospital stay of the patient	duration till patient is discharged in days	1 to 3 days postoperative
Secondary	hemoglobin drop of the patients	decrease in the hemoglobin level in comparison to the preoperative results	first day postoperative
Secondary	postoperative urine leakage from the surgical wound	urine leakage from the nephrostomy site if it present or not as document during surgical dressing by the attending physician	first day postoperative
Secondary	cost analysis of both procedure	cost of each procedure including operative cost and postoperative stay in Egyptian Pound	3 days postoperative