The Incidence of Pulmonary Embolism During Nephrectomy

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04402749
Collaborator
(none)
450
1
26.9
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nephrectomy

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 Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Nephrectomy

Patients underwent nephrectomy

Other: Nephrectomy
Patients underwent nephrectomy

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Length of stay [7 days after surgery]

    Hospital stay ICU stay

  3. Number of patients with postoperative organ dysfunction [7 days after surgery]

    Organ dysfunction acute kidney injury acute respiratory distress syndrome

  4. 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)

  5. Mortality rate at 30 days postoperative [30 days after surgery]

    Patients death after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients with renal cancer undergoing nephrectomy
Exclusion Criteria:
  • Patients with incomplete data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Siriraj Hospital Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Aphichat Suphathamwit, M.D., Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT04402749
Other Study ID Numbers:
  • 2020_2
First Posted:
May 27, 2020
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022