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

NCT04764071 | Unknown Phase 3 DMC

• 1 other identifier: MD 06 /2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stone, Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• operative time of both procedures

  intraoperative finding

• hospital stay of the patient

  1 to 3 days postoperative

• hemoglobin drop of the patients

  first day postoperative

• postoperative urine leakage from the surgical wound

  first day postoperative

• cost analysis of both procedure

  3 days postoperative

Study Arms (2)

percutaneous nephrolithotomy

ACTIVE COMPARATOR

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.

Procedure: percutaneous nephrolithotomy

ultra-mini percutaneous nephrolithotomy

EXPERIMENTAL

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.

Procedure: ultra-mini percutaneous nephrolithotomy

Interventions

percutaneous nephrolithotomy PROCEDURE

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.

percutaneous nephrolithotomy

ultra-mini percutaneous nephrolithotomy PROCEDURE

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.

ultra-mini percutaneous nephrolithotomy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11367, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Ashraf Satour, Master degree of Urology

CONTACT

01000396284; ahsrafsatour@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, the Data Collector, and the statistician were blinded to the arms of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: To compare the difference between the two procedures regarding stone-free rates, operative time, hospital stay, procedures cost, and operative complications including blood loss, the need for blood transfusion, and extravasation or urine leakage

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 21, 2021
• Study Start: February 28, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

EG (1)