The Incidence of Pulmonary Embolism During Nephrectomy

Completed

• Conditions: Nephrectomy; Renal Cell Carcinoma; Pulmonary Embolism
• Interventions: Other: Nephrectomy

• Registration Number: NCT04402749
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-24
• Study First Posted: 2020-05-27
• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• Adult patients with renal cancer undergoing nephrectomy

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Exclusion Criteria

• Patients with incomplete data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nephrectomy	Nephrectomy	Patients underwent nephrectomy

Primary Outcome Measures

Name	Time	Method
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy	intraoperative period	Pulmonary 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 Outcome Measures

Name	Time	Method
The incidence of postoperative PE of renal cancer patient undergoing nephrectomy	until 7 days after surgery	Pulmonary 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 stay	7 days after surgery	* Hospital stay; * ICU stay
Mortality rate at 30 days postoperative	30 days after surgery	Patients death after surgery
Number of patients with postoperative organ dysfunction	7 days after surgery	Organ dysfunction; * acute kidney injury; * acute respiratory distress syndrome
Rate of TEE utilization	7 days after surgery	TEE utilization; * for monitoring (use when the case begins); * for rescue (use when unexplained hypotension or hemodynamic collapsed)

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand