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The Incidence of Pulmonary Embolism During Nephrectomy

The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04402749
Enrollment
416
Registered
2020-05-27
Start date
2020-10-01
Completion date
2022-12-30
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrectomy, Pulmonary Embolism, Renal Cell Carcinoma

Brief summary

Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome.

Detailed description

Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava. Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited. The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome.

Interventions

OTHERNephrectomy

Patients underwent nephrectomy

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients with renal cancer undergoing nephrectomy

Exclusion criteria

* Patients with incomplete data

Design outcomes

Primary

MeasureTime frameDescription
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomyintraoperative periodPulmonary embolism * Clinical suspicious:Systolic blood pressure \< 90 mmHg without other reasonable causes, partial pressure of oxygen in artery \< 80 mmHg * Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan

Secondary

MeasureTime frameDescription
The incidence of postoperative PE of renal cancer patient undergoing nephrectomyuntil 7 days after surgeryPulmonary embolism * Clinical suspicious:Systolic blood pressure \< 90 mmHg without other reasonable causes, partial pressure of oxygen in artery \< 80 mmHg * Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
Length of stay7 days after surgery* Hospital stay * ICU stay
Number of patients with postoperative organ dysfunction7 days after surgeryOrgan dysfunction * acute kidney injury * acute respiratory distress syndrome
Rate of TEE utilization7 days after surgeryTEE utilization * for monitoring (use when the case begins) * for rescue (use when unexplained hypotension or hemodynamic collapsed)
Mortality rate at 30 days postoperative30 days after surgeryPatients death after surgery

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026