Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery

Prostatic Neoplasms Clinical Trial

Official title:

Comparison of the Impacts of Prolonged Low-pressure and Standard-pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery in the Trendelenburg Position: a Bi-center, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02600481
• Other study ID #: 2015K060
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: November 8, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: Huadong Hospital
• Contact: Weidong Gu, Doctor
• Phone: +86-21-62483180
• Email: mcwgwd[@]163.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged robot-assisted surgeries in the Trendelenburg position.

Description:

The hypothesis of this study is based on several studies reported that increased postoperative troponin T(TnT) level was significantly associated with 30-day mortality, and some other reports showed that low-pressure pneumoperitoneum had better haemodynamic outcome than that of standard-pressure pneumoperitoneum. Hence, we hypothesize that different pneumoperitoneal pressure may lead to different levels of TnT after prolonged robot-assisted surgeries.

This clinical trial will be conducted in Huadong Hospital Affiliated to Fudan University and Ruijin Hospital Shanghai Jiao Tong University School of Medicine,both are tertiary hospitals in Shanghai, China.

After signing the Informed Consent, subjects who meet the eligibility criteria will be randomly assigned to low- or standard-pressure pneumoperitoneum group.The randomization plans will be implemented using statistical software R, and will be stored in an online database.These subjects will be recruited from January 1st 2016 to December 31st 2017.

TnT is set as the primary endpoint for this trial to evaluate the myocardial injuries, and will be measured for each patient who will undergo in-patient robot-assisted urological surgery within 24 hours postoperatively using the fourth-generation high-sensitivity TnT assay.

The total sample size will be 280.With 140 patients in each of the two treatment groups, the power will be at least 0.70 to detect an increment of TnT level among 80% of subjects.Chest CT scan is used to diagnose the pulmonary complications on the third day postoperatively.

Data will be collected to analysize whether prolonged different intraperitoneal pressure has different impacts on cardiopulmonary injuries.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who are scheduled to undergo Robot-assisted radical prostatectomy or other robot-assisted urological surgeries last longer than 3 hours

• Patients who are classified as American Society of Anesthesiologists(ASA)I and II

• Patient's preoperative troponin T(TnT) level is normal

Exclusion Criteria:

• Patients with preoperative cardiopulmonary dysfunction who can not understand prolonged surgeries in the Trendelenburg position:severe pulmonary dysfunction or New York Heart Association(NYHA) classification is ?-?.

• Body Mass Index>30.

• Any intraoperative situation as follows:1. Any cause to cancel operation or change robot-assisted surgery to open surgery 2. Intraoperative cardiovascular accidents.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Injury
• Neoplasms
• Pneumoperitoneum
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

Procedure:
• low-pressure pneumoperitoneum
Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
• standard-pressure pneumoperitoneum
Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Huadong Hospital	Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries		Within the first 24 hours after prolonged robot-assisted surgeries	No
Secondary	Chest CT scan is used to determine pulmonary complications		On the third day after prolonged robot-assisted surgeries	No

External Links

•   Click here for more information about this study:the study's four objectives were to determine the diagnostic criteria, characteristics, predictors, and 30-day outcomes of MINS(myocardial injury after noncardiac surgery, MINS).