Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04096534
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Sponsor:
Saint Petersburg State University, Russia
Organization:
Study Overview
Official Title:
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORPN
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: