Prostatic Neoplasms, Urinary Bladder Neoplasms
Conditions
Keywords
standard-pressure pneumoperitoneum, prolonged pneumoperitoneum, myocardial injuries, troponin T(TnT), Trendelenburg position, chest CT scan, low-pressure pneumoperitoneum, robot-assisted surgery
Brief 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.
Detailed 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.
Interventions
PROCEDURElow-pressure pneumoperitoneum
Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
PROCEDUREstandard-pressure pneumoperitoneum
Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
Sponsors
Ruijin Hospital
Huadong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 Ⅲ-Ⅳ. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Chest CT scan is used to determine pulmonary complications | On the third day after prolonged robot-assisted surgeries |
Countries
China
Contacts
Primary ContactWeidong Gu, Doctor
Backup ContactXixue Zhang, Master
Outcome results
None listed