Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

• Sponsor: RenJi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03892031
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Circulatory Function; Laparoscopic Radical Cystectomy for Bladder Cancer

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 Design

• Study Type: Observational
• Actual Enrollment: 186 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Stroke Volume Variation(SVV) [before induction (T1), at the end of operation (T2)]

   To observe the change of SVV perioperatively.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• undergoing laparoscopic radical cystectomy for bladder cancer

• ASA I-II

Exclusion Criteria:

• Cardiac insufficiency

• Hepatic insufficiency

• Renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiaotong University, China	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• RenJi Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DAN HUANG, Principal Investigator, clinical attending in anesthesia department, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT03892031
• Other Study ID Numbers: Circulatory function in LRC
• First Posted: Mar 27, 2019
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by DAN HUANG, Principal Investigator, clinical attending in anesthesia department, RenJi Hospital: brain natriuretic peptide; pneumoperitoneum; Trendelenburg; circulatory function; laparoscopic radical cystectomy for bladder cancer; central venous pressure; stroke volume variation; transthoracic echocardiography
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 17, 2022