The Incidence of Pulmonary Embolism During Nephrectomy

NCT ID: NCT04402749

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 416 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-12-30

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.

Conditions

Pulmonary Embolism; Renal Cell Carcinoma; Nephrectomy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Nephrectomy

Patients underwent nephrectomy

Nephrectomy

Intervention Type: OTHER

Patients underwent nephrectomy

Interventions

Nephrectomy

Patients underwent nephrectomy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with renal cancer undergoing nephrectomy

Exclusion Criteria

• Patients with incomplete data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aphichat Suphathamwit, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Locations

Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

References

Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011.

Reference Type: BACKGROUND

PMID: 21377083 (View on PubMed)

Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l.

Reference Type: RESULT

PMID: 8212439 (View on PubMed)

Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026.

Reference Type: RESULT

PMID: 17113889 (View on PubMed)

Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15.

Reference Type: RESULT

PMID: 31072702 (View on PubMed)

Other Identifiers

2020_2

Identifier Type: -

Identifier Source: org_study_id