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Recruiting NCT07326280

The Cold Ischemia Robot-assisted Partial Nephrectomy

No phase Interventional Renal Cell Carcinoma Renal Function Abnormal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cold ischemia robot-assisted partial nephrectomy, Warm ischemia robot-assisted partial nephrectomy.
Who it may be relevant to
Registry conditions: Renal Cell Carcinoma, Renal Function Abnormal. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study

Overview

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.

Detailed description

Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia partial nephrectomy and the other undergoing warm ischemia partial nephrectomy. Comparing the short-term renal function recovery between the two groups.

Interventions

  • Procedure Cold ischemia robot-assisted partial nephrectomy
    During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
  • Procedure Warm ischemia robot-assisted partial nephrectomy
    Not applying local hypothermia to the kidneys during the surgical procedure

Primary outcome measures

  • Recovery from ischemia [Time frame: 1-12 months after surgery]
Secondary outcome measures (3)
  • surgical duration [Time frame: Intraoperative]
  • surgical complications [Time frame: 1-12 months after surgery]
  • The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12). [Time frame: up to 2 years after surgery]

Eligibility criteria

Inclusion criteria

\- 18 to 80 years old; 2. Intending to perform robot-assisted partial nephrectomy

Exclusion criteria

  • Anesthesiologist assessment: Patient unsuitable for general anesthesia;
  • Having severe cardiovascular and cerebrovascular diseases;
  • horseshoe kidney;
  • pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • 651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Sun Yat-sen University Canc — Guangzhou

Identifiers

NCT: NCT07326280 · SL-B2022-518-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗