NCT04096534

Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Saint Petersburg State University, Russia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Renal Malignant Tumor
• Renal Tumor

Interventions

Type	Name	Description
PROCEDURE	Normotonic partial nephrectomy	partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg
PROCEDURE	Hypotonic partial nephrectomy	partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg

Timeline

• Start date: 2019-10-07
• Primary completion: 2022-05-07
• Completion: 2022-05-07
• First posted: 2019-09-20
• Last updated: 2022-05-25

Locations

1 site across 1 country: Russia