Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

Circulatory Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892031
• Other study ID #: Circulatory function in LRC
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Cardiac insufficiency
• Hepatic insufficiency
• Renal insufficiency

Related Conditions & MeSH terms

• Circulatory Function
• Laparoscopic Radical Cystectomy for Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University, China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Natriuretic Peptide(BNP)	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
Primary	Central Venous Pressure(CVP)	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
Primary	Stroke Volume Variation(SVV)	To observe the change of SVV perioperatively.	before induction (T1), at the end of operation (T2)
Primary	Transthoracic Echocardiography	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