Clinical trial NCT04610840: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Keywords: urolithiasis
PCNL
direct puncture
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Puncture duration
timeFrame: during the operation (mini-PCNL)
measure: Number of patients with successful direct puncture
timeFrame: during the operation (mini-PCNL)
measure: Purity of a visual intraoperative field
timeFrame: during the operation (mini-PCNL)
measure: Body pain
timeFrame: 24 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg University
Study officials:
References: