The Cold Ischemia Robot-assisted Partial Nephrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Anesthesiologist assessment: Patient unsuitable for general anesthesia;
Having severe cardiovascular and cerebrovascular diseases;
horseshoe kidney;
pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
Cold ischemia robot-assisted partial nephrectomy
Procedure/SurgeryDuring the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
Warm ischemia robot-assisted partial nephrectomy
Procedure/SurgeryNot applying local hypothermia to the kidneys during the surgical procedure
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Cold ischemiaExperimental treatment 1 intervention
Group B: Warm ischemiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recovery from ischemia
(%GFR saved)/(%parenchymal mass preserved)
Time frame
1-12 months after surgerySecondary outcomes
1
surgical duration
The duration of the surgery
Time frame
Intraoperative2
surgical complications
Intraoperative and postoperative complication incidence rate
Time frame
1-12 months after surgery3
The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12).
Postoperative short-term GFR(months 1-12) minus long-term GFR(month13-24)
Time frame
up to 2 years after surgerySponsors and contacts
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Source ClinicalTrials.gov