The Use of Direct Puncture Technique With Mini-PCNL | NCT04610840

Studies
The Use of Direct Puncture Technique With Mini-PCNL

NCT04610840

Sponsor

St. Petersburg State Pavlov Medical University

Status

Unknown status

Last Update Posted

Nov 9, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Urolithiasis

Interventions

Puncture of the caliceal system

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Feb 1, 2022Estimated

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Oct 26, 2020

First Posted Date

Nov 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:
1. all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
2. ASA scale 1-3
3. Solitary stone up to 2.5 cm
4. Single access to the caliceal system
Exclusion criteria:
1. Active infectious process
2. Coagulopathies
3. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Direct puncture	Active Comparator	Direct puncture of the caliceal system performed under ultrasound or Xray control	Procedure: Puncture of the caliceal system
Non-direct puncture	Active Comparator	Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast	Procedure: Puncture of the caliceal system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Puncture of the caliceal system	Procedure	Puncture of the caliceal system under ultrasound/Xray control	Direct puncture Non-direct puncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Puncture duration	Measurement of puncture duration (in seconds)	during the operation (mini-PCNL)
Number of patients with successful direct puncture	Evaluation of efficacy	during the operation (mini-PCNL)
Purity of a visual intraoperative field	Excellent, Moderate, Poor visualization	during the operation (mini-PCNL)
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	24 hours after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dmitry S Gorelov	Contact	+79217964892		dsgorelov@mail.ru
Vladimir M Obidniak	Contact	+79218944746		v.obidniak@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Pavlov Saint Petersburg University	Recruiting	Saint Petersburg		197342	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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