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PE20 A single centre randomized controlled trial assessing the effect of the Airseal® system on operation times for totally intracorporeal RARC.

Authors:
Sanchez-Salas R.
Sanchez-Salas R.
Sanchez-Salas R.
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Justin W Collins at University College London Hospitals NHS Foundation Trust
Justin W Collins
Adding C.
Adding C.
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Oscar Laurin at Karolinska University Hospital
Oscar Laurin
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Abstract

Introduction and objectives: AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO2) recirculation during robotic/laparoscopic surgery. Comparative data to standard CO2 pressure pneumoperitoneum insufflators is needed to properly assess its use. The aim of this study was to evaluate the potential advantages of AirSeal® compared to a standard CO2 insufflator. Material and methods: This was a single center randomized trial comparing elective surgery for men and women undergoingRobotic assisted radical cystectomy (RARC), with extended pelvic lymph node dissection (EPLND) and intracorporeal urinary diversion (ICUD) with AirSeal® versus a standard CO2 pressure insufflator. The primary outcome measure was operative time, defined as the time from knife to skin (placement of first port) to closure of skin (staples to port sites at end of RARC). Operation times were also recorded for each stage of the operation: RARC, EPLND and ICUD. Secondary outcomes were blood loss, hospital length of stay and complications according to the Clavien-Dindo classification. The total number of patients recruited was 100 (n=50 per group). All tests are two-sided with a confidence level of 95% (P <0.05). Results: Out of the 100 patients 50 underwent ileal conduit diversion (34 included in Airseal group and 31 in Non Airseal group) and 50 received neobladders (16 included in Airseal group and 19 in Non Airseal group). Overall mean operation time for the Airseal group was 296.8 min (Std Dev 58.29) and for the Non Airseal group was 329.9 with a p-value 0.0154. For the ileal conduits in the Airseal group was 284.0 min (Std Dev 51.36) and for the Non Airseal group was 304.6 min (Std Dev 73.69), p-value 0.1930. For the neobladders overall mean operation time was 324.0 min (Std Dev 64.34) in the Airseal group and 371.1 min (Std Dev 56.75) in the Non Airseal group, p-value 0.0289. Blood loss for the group with Airseal was 221mls (Std Dev 205.8) and in the Non Airseal group was 271 mls (Std Dev 313.8) with a p-value 0.3485. For the ileal conduits in the Airseal group was 155.9 mls (Std Dev 79.55) and for the Non Airseal group was 226.6 mls (Std Dev 311.4), p-value 0.2318. For the neobladders blood loss in Airseal Group was 359.4 mls (Std Dev 307.3) and in the Non Airseal group was 350 mls (Std Dev 309.6), p-value 0.9292. Conclusions: In our study AirSeal® resulted in a more stable working environment and impacted operation times. The AirSeal® Trocar resulted in significantly shorter overall operating times. The duration of an operation is an important factor in reducing the patient’s exposure to surgical risks.

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... More likely, the compressive effects on renal parenchyma and the inferior vena cava inhibited glomerular filtration rate, creatinine clearance, sodium excretion and urine output. Recently, a new technology (AirSeal™) has been shown to decrease the risks from pneumoperitoneal CO 2 shifts by providing a more stable working environment which decreased operation times in prostate surgery [22] and improved clinical outcomes by decreasing the surgical stress during RARC [23]. ...
Is robotic-assisted radical cystectomy (RARC) with intracorporeal diversion becoming the new gold standard of care?
Article
Full-text available
  • Jan 2016
  • WORLD J UROL
Background: Totally intracorporeal robotic-assisted radical cystectomy (RARC) has perceived difficulties compared to open radical cystectomy (ORC). As the technique is increasingly adopted around the world, the benefits of RARC with intra- or extracorporeal urinary diversion or ORC for the patients are still unclear. In this article, we consider the current evidence for this issue. Methods: We assessed two questions through using expert opinion and the medical literature: (A) Is RARC better than ORC for removing the cancer surgery and outcome? (B) Is RARC better than ORC for the urinary diversion? Outcomes: (A) RARC is better than ORC for shorter length of stay, blood loss and complication rates. (B) Intracorporeal orthotopic neobladder may have a significant physiological and surgical benefit to the patient recovery. Conclusions: RARC with total intracorporeal reconstruction has potential benefits to the patient. We recommend that all surgeons document patient-related outcome measures, urodynamics and enhanced recovery protocols for cystectomy patients to help us understand the real improvements within bladder cancer surgery and reconstruction.
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