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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03058250
Enrollment
80
Registered
2017-02-20
Start date
2012-12-31
Completion date
2016-05-31
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERTransesophageal echocardiography

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative central venous line insertion1 day after study enrollment
postoperative return of bowel function via flatus or passage of stool5 days after study enrollment

Secondary

MeasureTime frame
Decreased postoperative pulmonary and cardiac complicationsapproximately 5-7 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026