Clinical trial NCT04402749: The Incidence of Pulmonary Embolism During Nephrectomy
Official title: The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Renal Cell Carcinoma
Nephrectomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every adult patients with renal carcinoma underwent nephrectomy will be recruited.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with renal cancer undergoing nephrectomy

Exclusion Criteria:

* Patients with incomplete data

Primary outcomes:
measure: The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy
timeFrame: intraoperative period
Secondary outcomes:
measure: The incidence of postoperative PE of renal cancer patient undergoing nephrectomy
timeFrame: until 7 days after surgery
measure: Length of stay
timeFrame: 7 days after surgery
measure: Number of patients with postoperative organ dysfunction
timeFrame: 7 days after surgery
measure: Rate of TEE utilization
timeFrame: 7 days after surgery
measure: Mortality rate at 30 days postoperative
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
name: Aphichat Suphathamwit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.