Clinical trial NCT02600481: Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Neoplasms
Urinary Bladder Neoplasms
Keywords: standard-pressure pneumoperitoneum
prolonged pneumoperitoneum
myocardial injuries
troponin T(TnT)
Trendelenburg position
chest CT scan
low-pressure pneumoperitoneum
robot-assisted surgery
Lead sponsor: Huadong Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2015-11-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries
timeFrame: Within the first 24 hours after prolonged robot-assisted surgeries
Secondary outcomes:
measure: Chest CT scan is used to determine pulmonary complications
timeFrame: On the third day after prolonged robot-assisted surgeries
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Huadong Hospital
name: Weidong Gu, Doctor
role: STUDY_CHAIR
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