PD23-07 A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE THE SAFETY OF A VALVE-LESS TROCAR INSUFFLATION SYSTEM (AIRSEAL) VS. CONVENTIONAL INSUFFLATION FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY

Abstract

You have accessJournal of UrologySurgical Technology & Simulation: Instrumentation & Technology II (PD23)1 Apr 2020PD23-07 A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE THE SAFETY OF A VALVE-LESS TROCAR INSUFFLATION SYSTEM (AIRSEAL) VS. CONVENTIONAL INSUFFLATION FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY Michael Stifelman*, Sam Bhayani, Robert Figenshau, and James Porter Michael Stifelman*Michael Stifelman* More articles by this author , Sam BhayaniSam Bhayani More articles by this author , Robert FigenshauRobert Figenshau More articles by this author , and James PorterJames Porter More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000873.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The use of valve-less insufflation is gaining significant popularity for robotic partial nephrectomy secondary to its ability to maintain a pneumoperitoneum during constant vigorous suction. This study evaluated a valve-less trocar system (AirSeal) compared with conventional insufflation and the effects of insufflation pressure on peri-operative safety outcomes. METHODS: Subjects from three institutions were randomized equally in a 1:1:1 ratio into three different study arms: AirSeal - 12mmHg pressure (AIS12); AIS - 15mmHg (AIS15); and Conventional Insufflation - 15mmHg (CIS15). The rate of subcutaneous emphysema (SE) constituted the primary safety endpoint and was identified by physical exam intraoperatively, post-operatively and chest x-ray (CXR). Secondary safety endpoints included: pneumothorax, and/or pneumomediastinum identified on post-operative CXR and post-operative shoulder pain measured via a Visual Analogue Scale (VAS) administered during predetermined times after surgery. RESULTS: A total of 198 patients were enrolled (n=66 in each study arm). There were no statistically significant differences in demographics including sex, ethnicity, age or BMI between the three groups. There was a statistically significant reduction in the rate of SE between AIS12 (15.25%) and CIS15 (30.9%) with a p value of 0.008. The incidence of pneumothorax was 0%, 5% and 5% for AIS12, AIS15 and CIS15, respectively (p=0.12). The incidence of pneumomediastinum was 6%, 12% and 11% for AIS12, AIS15 and CIS15, respectively (p=0.36). An 11.5% reduction in postoperative shoulder pain was seen in AIS12 vs. CIS15 ( p=.0.049) and 14% reduction in shoulder pain AIS15 vs. CIS15 ( p=0.01). Two patients randomized to CIS15 required conversion to AIS15 secondary to poor visualization and bleeding. CONCLUSIONS: This study demonstrates that utilizing AIS12 provides a significant reduction in the incidence of SE compared to CIS15 in patients undergoing robotic partial nephrectomy. In addition, the use of the Airseal system at both 12mmHg and 15mmHg reduces postoperative shoulder pain compared with conventional insufflation. This suggests that for patients undergoing robotic partial nephrectomy the use of AIS 12 provides the highest safety profile compared to CIS15. Source of Funding: Conmed © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e466-e466 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Stifelman* More articles by this author Sam Bhayani More articles by this author Robert Figenshau More articles by this author James Porter More articles by this author Expand All Advertisement PDF downloadLoading ...