The Use of Direct Puncture Technique With Mini-PCNL

Not Applicable

• Conditions: Urolithiasis
• Interventions: Procedure: Puncture of the caliceal system

• Registration Number: NCT04610840
• Lead Sponsor: St. Petersburg State Pavlov Medical University

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:

1. Gender

2. Age

3. Body mass index

4. Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)

5. Density of the stone

6. The presence of hydronephrosis

Indicators assessed during the operation - will be assessed by the physician-researcher:

1. Installation of the ureteral catheter

2. Duration of puncture

3. Puncture method (ultrasound, X-ray)

4. The success of the insertion of a flexible guidewire into the calyceal system

5. Problems during dilation of the puncture course

6. Visualization (Excellent, Moderate, Poor)

7. 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

1. Complications (Clavien)

2. Hemoglobin level 24 hours after surgery

3. Creatinine level 24 hours after surgery

4. Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-02-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct puncture	Puncture of the caliceal system	Direct puncture of the caliceal system performed under ultrasound or Xray control
Non-direct puncture	Puncture of the caliceal system	Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast

Primary Outcome Measures

Name	Time	Method
Body pain	24 hours after operation	Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Number of patients with successful direct puncture	during the operation (mini-PCNL)	Evaluation of efficacy
Purity of a visual intraoperative field	during the operation (mini-PCNL)	Excellent, Moderate, Poor visualization
Puncture duration	during the operation (mini-PCNL)	Measurement of puncture duration (in seconds)

Trial Locations

Locations (1)

First Pavlov Saint Petersburg University; 🇷🇺 Saint Petersburg, Russian Federation