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

Primary Purpose

Stone, Kidney

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous nephrolithotomy
ultra-mini percutaneous nephrolithotomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stone, Kidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

percutaneous nephrolithotomy

ultra-mini percutaneous nephrolithotomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

operative time of both procedures
time of each procedure in minutes from the lithotomy positioning till completion of the procedure
hospital stay of the patient
duration till patient is discharged in days
hemoglobin drop of the patients
decrease in the hemoglobin level in comparison to the preoperative results
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
cost analysis of both procedure
cost of each procedure including operative cost and postoperative stay in Egyptian Pound

Full Information

First Posted
February 14, 2021
Last Updated
February 18, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04764071
Brief Title
Ultra-Mini Versus Standard Percutaneous Nephrolithotomy For Management Of Renal Calculi. A Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2021 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, the Data Collector, and the statistician were blinded to the arms of the study.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
percutaneous nephrolithotomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ultra-mini percutaneous nephrolithotomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrolithotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ultra-mini percutaneous nephrolithotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
stone free rate of patients with renal stones by non contrast CT scan
Description
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
Time Frame
first day postoperative
Secondary Outcome Measure Information:
Title
operative time of both procedures
Description
time of each procedure in minutes from the lithotomy positioning till completion of the procedure
Time Frame
intraoperative finding
Title
hospital stay of the patient
Description
duration till patient is discharged in days
Time Frame
1 to 3 days postoperative
Title
hemoglobin drop of the patients
Description
decrease in the hemoglobin level in comparison to the preoperative results
Time Frame
first day postoperative
Title
postoperative urine leakage from the surgical wound
Description
urine leakage from the nephrostomy site if it present or not as document during surgical dressing by the attending physician
Time Frame
first day postoperative
Title
cost analysis of both procedure
Description
cost of each procedure including operative cost and postoperative stay in Egyptian Pound
Time Frame
3 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patient aged over 18 with renal stone between 1 and 2 cm Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf Satour, Master degree of Urology
Phone
01000396284
Ext
+2
Email
ahsrafsatour@yahoo.com
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11367
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Satour, master degree
Phone
01000396284
Email
ashrafsatour@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.

Learn more about this trial

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

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