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This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).
Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF.
A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.
The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.
Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).
Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
According to preliminary calculations, taking into account type I error of 5% and power of 80%, 100 patients should be included in the study. In order to compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). The expected duration of the study is 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normotonic partial nephrectomy | Experimental | Performing a partial nephrectomy under normal body blood pressure |
|
| Hypotonic partial nephrectomy | Active Comparator | Performing a partial nephrectomy under hypotonic body blood pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normotonic partial nephrectomy | Procedure | partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | glomerular filtration rate calculation (mL/min), nephroscintigraphy | within the first 3 month after surgery |
| Blood loss | Volume of intraoperative blood loss (ml) | enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Survival without local or systemic recurrence (months) | 1 year after last patient enrolled |
| Resection margins status | Evaluating of resection margins status (positive/negative) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran Dzhalilov, MD | Saint Petersburg State University, Russia | Study Director |
| Vladislav Osetnik, MD | Saint Petersburg State University, Russia | Principal Investigator |
| Batyrbek Aslanov, PhD | Mechnikov North-West State Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University Clinic | Saint Petersburg | Russia |
We are not planning to share personal patient data
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Hypotonic partial nephrectomy | Procedure | partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg |
|
| enrollment |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |