Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery
NCT ID: NCT02600481
Last Updated: 2015-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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low-pressure pneumoperitoneum group
Subjects assigned to the low-pressure pneumoperitoneum group will receive 7-10 mm Hg carbon dioxide pneumoperitoneum, and the expected duration is longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;
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 group
Subjects assigned to the standard-pressure pneumoperitoneum group will receive 12-16 mm Hg carbon dioxide pneumoperitoneum, which is expected lasted longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;
standard-pressure pneumoperitoneum
Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients who are classified as American Society of Anesthesiologists（ASA）I and II
* Patient's preoperative troponin T(TnT) level is normal
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Huadong Hospital
OTHER
Responsible Party
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Principal Investigators
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Weidong Gu, Doctor
Role: STUDY_CHAIR
Huadong Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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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).
Other Identifiers
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2015K060
Identifier Type: -
Identifier Source: org_study_id
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