NCT02600481

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Huadong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Interventions

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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-11-09
• Last updated: 2015-11-10

Locations

1 site across 1 country: China