Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

Completed

• Conditions: Circulatory Function; Laparoscopic Radical Cystectomy for Bladder Cancer

• Registration Number: NCT03892031
• Lead Sponsor: RenJi Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

• Cardiac insufficiency
• Hepatic insufficiency
• Renal insufficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain Natriuretic Peptide(BNP)	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.
Central Venous Pressure(CVP)	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.
Stroke Volume Variation(SVV)	before induction (T1), at the end of operation (T2)	To observe the change of SVV perioperatively.
Transthoracic Echocardiography	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

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University, China; 🇨🇳 Shanghai, Shanghai, China