Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

February 16, 2022 updated by: DAN HUANG, RenJi Hospital

Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer

To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).

Study Overview

Status

Completed

Conditions

Detailed Description

Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo laparoscopic radical cystectomy for bladder cancer in Renji Hospital

Description

Inclusion Criteria:

  • undergoing laparoscopic radical cystectomy for bladder cancer
  • ASA I-II

Exclusion Criteria:

  • Cardiac insufficiency
  • Hepatic insufficiency
  • Renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Natriuretic Peptide(BNP)
Time Frame: before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of BNP perioperatively.
before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Central Venous Pressure(CVP)
Time Frame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of CVP perioperatively.
before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Stroke Volume Variation(SVV)
Time Frame: before induction (T1), at the end of operation (T2)
To observe the change of SVV perioperatively.
before induction (T1), at the end of operation (T2)
Transthoracic Echocardiography
Time Frame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of End-diastolic volume(EDV) perioperatively
before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Jie Chen, MS, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Circulatory function in LRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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