NCT03058250

Brief Summary

This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

February 13, 2017

Last Update Submit

February 21, 2023

Conditions

Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery

Outcome Measures

Primary Outcomes (2)

  • Incidence of intraoperative central venous line insertion

    1 day after study enrollment

  • postoperative return of bowel function via flatus or passage of stool

    5 days after study enrollment

Secondary Outcomes (1)

  • Decreased postoperative pulmonary and cardiac complications

    approximately 5-7 days

Study Arms (2)

Control

NO INTERVENTION

Standard of care, no intervention

Transesophageal echocardiography

ACTIVE COMPARATOR

Patients will have intraoperative transesophageal echocardiography along with standard of care for management.

Other: Transesophageal echocardiography

Interventions

Transesophageal echocardiographyOTHER
Transesophageal echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients have elective radical cystectomy at The University of Chicago Hospital.

You may not qualify if:

  • Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 20, 2017

Study Start

December 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2016

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share