Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Standard of care, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Transesophageal echocardiography

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

Group Type ACTIVE_COMPARATOR

Transesophageal echocardiography

Intervention Type OTHER

Interventions

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Transesophageal echocardiography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No