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Completed

NCT Number: NCT03892031

Circulatory Function in 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).

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Key information

Conditions

Circulatory Function Digestive System Diseases Laparoscopic Radical Cystectomy for Bladder Cancer Peritoneal Diseases Pneumoperitoneum

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cardiac insufficiency
  • Hepatic insufficiency
  • Renal insufficiency

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Stroke Volume Variation(SVV)

    Time frame: before induction (T1), at the end of operation (T2)

    To observe the change of SVV perioperatively.

  4. 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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2019
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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