Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-07-01
2022-04-01
Brief Summary
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* 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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Direct puncture
Direct puncture of the caliceal system performed under ultrasound or Xray control
Puncture of the caliceal system
Puncture of the caliceal system under ultrasound/Xray control
Non-direct puncture
Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast
Puncture of the caliceal system
Puncture of the caliceal system under ultrasound/Xray control
Interventions
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Puncture of the caliceal system
Puncture of the caliceal system under ultrasound/Xray control
Eligibility Criteria
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Inclusion Criteria
* ASA scale 1-3
* Solitary kidney stone up to 2.5 cm
* One access to the caliceal system
Exclusion Criteria
* Coagulopathies
* Abnormalities of the urinary system
18 Years
70 Years
ALL
No
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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Locations
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First Pavlov Saint Petersburg University
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Dmitriy Gorelov, MD
Role: primary
Other Identifiers
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03/20-н
Identifier Type: -
Identifier Source: org_study_id