NCT04402749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

May 7, 2020

Last Update Submit

March 15, 2023

Conditions

Pulmonary EmbolismRenal Cell CarcinomaNephrectomy

Outcome Measures

Primary Outcomes (1)

  • The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy

    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

    intraoperative period

Secondary Outcomes (5)

  • The incidence of postoperative PE of renal cancer patient undergoing nephrectomy

    until 7 days after surgery

  • Length of stay

    7 days after surgery

  • Number of patients with postoperative organ dysfunction

    7 days after surgery

  • Rate of TEE utilization

    7 days after surgery

  • Mortality rate at 30 days postoperative

    30 days after surgery

Study Arms (1)

Nephrectomy

Patients underwent nephrectomy

Other: Nephrectomy

Interventions

NephrectomyOTHER

Patients underwent nephrectomy

Nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every adult patients with renal carcinoma underwent nephrectomy will be recruited.

You may qualify if:

  • Adult patients with renal cancer undergoing nephrectomy

You may not qualify if:

  • Patients with incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 21377083BACKGROUND

  • 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.

    PMID: 8212439RESULT

  • 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.

    PMID: 17113889RESULT

  • 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.

    PMID: 31072702RESULT

MeSH Terms

Conditions

Pulmonary EmbolismCarcinoma, Renal Cell

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Aphichat Suphathamwit, M.D.

    Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 27, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)