The Use of Direct Puncture Technique With Mini-PCNL
Primary Purpose
Urolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Puncture of the caliceal system
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring urolithiasis, PCNL, direct puncture
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary kidney stone up to 2.5 cm
- One access to the caliceal system
Exclusion Criteria:
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
Sites / Locations
- First Pavlov Saint Petersburg UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Direct puncture
Non-direct puncture
Arm Description
Direct puncture of the caliceal system performed under ultrasound or Xray control
Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast
Outcomes
Primary Outcome Measures
Puncture duration
Measurement of puncture duration (in seconds)
Number of patients with successful direct puncture
Evaluation of efficacy
Purity of a visual intraoperative field
Excellent, Moderate, Poor visualization
Body pain
Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04610840
First Posted
August 5, 2020
Last Updated
November 8, 2021
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04610840
Brief Title
The Use of Direct Puncture Technique With Mini-PCNL
Official Title
Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
60 patients
Inclusion criteria:
all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
ASA scale 1-3
Solitary stone up to 2.5 cm
Single access to the caliceal system
Exclusion criteria:
Active infectious process
Coagulopathies
Abnormalities of the urinary system
Detailed Description
All patients will be randomized into 2 groups:
Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people.
Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people.
Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Primary assessed indicators:
Gender
Age
Body mass index
Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)
Density of the stone
The presence of hydronephrosis
Indicators assessed during the operation - will be assessed by the physician-researcher:
Installation of the ureteral catheter
Duration of puncture
Puncture method (ultrasound, X-ray)
The success of the insertion of a flexible guidewire into the calyceal system
Problems during dilation of the puncture course
Visualization (Excellent, Moderate, Poor)
Type of drainage (stent, nephrostomic tube) at the end of the operation Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery.
In the postoperative period, the patient independently controls the intake of analgesics from the NSAID group (ketorolac 100 mg) (Patient-controlled analgesia). If the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand).
Secondary Assessment: Postoperative Assessment
Complications (Clavien)
Hemoglobin level 24 hours after surgery
Creatinine level 24 hours after surgery
Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
urolithiasis, PCNL, direct puncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct puncture
Arm Type
Active Comparator
Arm Description
Direct puncture of the caliceal system performed under ultrasound or Xray control
Arm Title
Non-direct puncture
Arm Type
Active Comparator
Arm Description
Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast
Intervention Type
Procedure
Intervention Name(s)
Puncture of the caliceal system
Intervention Description
Puncture of the caliceal system under ultrasound/Xray control
Primary Outcome Measure Information:
Title
Puncture duration
Description
Measurement of puncture duration (in seconds)
Time Frame
during the operation (mini-PCNL)
Title
Number of patients with successful direct puncture
Description
Evaluation of efficacy
Time Frame
during the operation (mini-PCNL)
Title
Purity of a visual intraoperative field
Description
Excellent, Moderate, Poor visualization
Time Frame
during the operation (mini-PCNL)
Title
Body pain
Description
Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Time Frame
24 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
ASA scale 1-3
Solitary kidney stone up to 2.5 cm
One access to the caliceal system
Exclusion Criteria:
Active infectious process
Coagulopathies
Abnormalities of the urinary system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry S Gorelov
Phone
+79217964892
Email
dsgorelov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir M Obidniak
Phone
+79218944746
Email
v.obidniak@gmail.com
Facility Information:
Facility Name
First Pavlov Saint Petersburg University
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitriy Gorelov, MD
Phone
+79217964892
Email
dsgorelov@mail.ru
12. IPD Sharing Statement
Plan to Share IPD
No
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The Use of Direct Puncture Technique With Mini-PCNL
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