AirSeal® iFS: Insufflation durch klinische Daten gestützt

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7 March, 2025
Meta Analysis Systematic Review
A Comparison of CO2-related Complications in Partial Nephrectomies between the AirSeal® System and Conventional System: A Systematic Review and Meta-analysis
S Siddiqui, M Faizan, et al.
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18 December, 2024
Retrospective
Low vs Conventional Intra-Abdominal Pressure in Laparoscopic Colorectal Surgery: A Prospective Cohort Study
A Akingboye, M Hamid, et al.
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AirSeal at 8mmHg group experienced:
  • Improved intraoperative lung compliance and peak inspiratory pressures
  • Decreased post-op pain over 5 days both at rest and on exertion
  • Low IAP was associated with an earlier time to pass flatus post-op
1 September, 2024
Meta Analysis
Perioperative Outcomes and Safety of Valveless Insufflation System in Minimally Invasive Urological Surgery: A Systematic Review and Meta-analysis
Y Lu, Q Zou, et al.
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  • Significantly lower Clavien-Dindo III-IV complications
  • Significantly reduced general and shoulder pain at 12-24h post-op
  • Reduced LOS
23 July, 2024
Meta Analysis
Comparative Assessment of Safety and Efficacy between the AirSeal® System and Conventional Insufflation System in Robot-assisted Laparoscopic Radical Prostatectomy: A Systematic Review and Meta-analysis
W Zhi, Y Wang, et al.
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  • AirSeal results in shorter operative time, reduced hospital stays, and fewer major complications
26 June, 2024
Meta Analysis Systematic
Comparison of AirSeal vs Conventional Insufflation System for Robot-Assisted Partial Nephrectomy: A Meta-analysis and Systematic Review
G Fan, Y Chen, et al.
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AirSeal group showed:
  • Significantly lower rates of subcutaneous emphysema
  • 12hr post-op pain scores significantly lower
21 February, 2024
Randomized Controlled Trial
Comparison of AirSeal® vs Conventional Insufflation System for Retroperitoneal Robot-assisted Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
W Xu, M Wei, et al.
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AirSeal group showed:
  • Significantly lower subcutaneous emphysema rate than the conventional group
  • Significantly lower etCO2, PaCO2 at the end of the operation, lower tidal volumes and frequency of scope cleaning
  • Significantly lower post-op pain scores at 8hr, 12hr, and at time of discharge
13 September, 2023
Single Tertiary Center Study
The Impact of AirSeal® on Complications and Pain Management During Robotic-Assisted Radical Prostatectomy: A Single-Tertiary Center Study
A El-Hajj, C Ayoub, et al.
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AirSeal was associated with:
  • Shorter operative times by 12.3 minutes
  • Shorter length of hospital stay by 0.5 days
  • Lower odds of Clavien-Dindo complications
27 June, 2023
Retrospective
Comparison of Laparoscopic Partial Nephrectomy Performed with AirSeal® System vs Standard Insufflator: Results from a Referral Center
F Forte, S Sorrenti, et al.
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AirSeal group showed:
  • Lower operative time (107.5 min in AirSeal group vs. 120 min in SI group)
  • Lower complication rates
  • Decreased perioperative blood loss (1.45g/dL vs 2.2g/dL)
  • Reduced warm ischemia time (18 min vs. 20 min)
11 April, 2023
Prospective Consecutive
Comparing Different Pneumoperitoneum (12 vs. 15 mmHg) Pressures with Cytokine Analysis to Evaluate Clinical Outcomes in Patients Undergoing Robotic-assisted Laparoscopic Radical Cystectomy and Intracorporeal Robotic Urinary Diversion
N Vasdev, N Martin, et al.
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The 12mmHg AirSeal group:
  • Had a 40 min shorter operative time and 1-day shorter LOS than the 15mmHg group
  • Had fewer patients with ileus (10% vs. 30%) compared to the 15mmHg group
  • Passed flatus 1 day earlier and stooled 1.5 days earlier than 15mmHg group
  • The study found that patients in the 15mmHg AirSeal group had a higher risk of paralytic ileus post robotic cystectomy and robotic intracorporeal urinary diversion
1 March, 2023
Prospective Consecutive
Improved Outcomes Utilizing a Valveless-Trocar System during Robot-assisted Radical Prostatectomy (RARP)
D Lee, Mohammed S, et al.
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  • Procedures in AirSeal group were 12.6% shorter in duration
  • Patients in AirSeal group had fewer episodes of nausea (2% vs 10%)
  • Trend toward less pain in the AirSeal group within the first 24 hours after surgery
6 November, 2022
Retrospective
The Usefulness of AirSeal Intelligent Flow System in Gas Insufflation Total Endoscopic Thyroidectomy
H Katoh, Y Ikeda, et al.
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  • The AirSeal system significantly reduced the frequency of scope cleaning (p=0.016)
  • Time to disappearance of SCE around surgical cavity was significantly shorter in the AirSeal group (p=0.019)
  • When suctioning mist/smokes produced by an energy device, AirSeal prevented narrowing working space and greatly contributed to wide and clear visibility
1 September, 2022
Double Blinded Controlled Trial Randomized
Randomized Trial of Ultralow vs Standard Pneumoperitoneum during Robotic Prostatectomy
R Abaza, M Ferroni
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The 6mmHg group showed:
  • Significantly lower post-op pain scores
  • Improved ventilation - reduced etCO2 & PIP, reduced MAP
1 August, 2022
Consecutive Prospective
Review of Outcomes of Low vs Standard Pressure Pneumoperitoneum in Laparoscopic Surgery
W Richards, P Saway, et al.
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The AirSeal group showed:
  • Trends toward lower pain scores at discharge or 24 hours
  • Statistically lower PIP (peak inspiratory pressure)
  • Statistically lower etCO2
7 June, 2022
Meta Analysis
The Role of AirSeal® in Robotic Urologic Surgery: A Systematic Review
K Bedani, S Razdan, et al.
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The AirSeal group showed:
  • Lower inspiratory plateau pressure, lower minute volume, lower ETCO2, lower CO2 elimination rate, higher static compliance
  • Improved cardiopulmonary parameters
  • Some studies showed decreased complication rates at low pressure
14 March, 2022
Retrospective Multicenter
Low Pressure Laparoscopy Using the AirSeal® System vs Standard Insufflation in Early-Stage Endometrial Cancer: A Multicenter, Retrospective Study (ARIEL Study)
A Buda, G Di Martino, et al.
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AirSeal patients showed:
  • Lower incidence of post-operative shoulder pain
  • Lower severity of global pain at 4, 8, and 24 hours/li>
  • Significantly lower etCO2
  • Significantly lower Peak Airway Pressure
  • Significantly lower systolic blood pressure
  • Significantly faster recovery
  • 98% of patients were discharged within 2 days vs. 75% of patients in the standard group
19 August, 2021
Randomized Prospective
Low-pressure vs Standard Pressure Laparoscopic Colorectal Surgery (PAROS Trial): A Phase III Randomized Controlled Trial
Q Denost, S Celarier, et al.
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AirSeal at 7mmHg group experienced:
  • Reduced LOS (1 day)
  • Lower post-operative pain scores
  • Improved post-operative patient mobilization (sitting and walking)
1 July, 2021
Prospective Randomized Multicenter
Comparison of the Safety and Efficacy of Valveless and Standard Insufflation During Robotic Partial Nephrectomy: A Prospective, Randomized, Multi-institutional Trial
B Desroches, J Porter, et al.
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  • Patients in the 12mmHg AirSeal group developed SCE less often than patients in both the AirSeal 15mmHg and SI 15mmHg groups
  • There was no difference in SCE rates between patients in AirSeal 15mmHg and SI 15mmHg groups
  • Peak airway pressure was lower in both AirSeal groups VS. SI group
  • etCO2 was lower in the AirSeal 12mmHg group than both the AirSeal 15mmHg and SI 15mmHg groups
2 April, 2021
Consecutive Retrospective
High-Pressure CO2 Insufflation is a Risk Factor for Postoperative Ileus in Patients Undergoing TaTME
M Grieco, F Tirelli, et al.
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The low pressure group showed:
  • Decreased occurrence of post-op ileus
  • Shorter time to solid oral feeding
2 March, 2021
Retrospective Single Center
Medico-Economic Impact of the AirSeal® Insufflator: Example of Laparoscopic Sacrocolpopexy
I Boualaoui, E Bey, et al.
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The AirSeal group showed:
  • A statistically significant difference in the mean operating time (110 minutes in the AirSeal group vs. 121 minutes in the Standard Insufflation group)
  • Trend towards shorter LOS
  • Trend towards lower post-op pain
15 February, 2021
Retrospective
The Impact of the AirSeal® Valve-less Trocar System in Robotic Colorectal Surgery: A Single-Surgeon Retrospective Review
V Obias, J Paull, et al.
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AirSeal group showed:
  • Significantly shorter (20.8%) Low Anterior Resection procedure times (232 min vs. 293 min)
  • Significantly lower EBL (28.2%) in Low Anterior Resection procedures (150cc vs. 209cc)
22 June, 2020
Consecutive Prospective
Less is More: Clinical Impact of Decreasing Pneumoperitoneum Pressures During Robotic Surgery
J Huang, C Foley, et al.
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  • Each reduction in intraabdominal pressure corresponded to a significant decrease in initial pain scores and LOS
  • Patients in the AirSeal 8 & 10mmHg groups had significantly shorter lengths of stay compared to the high-pressure groups (12 & 15mmHg)
  • Each reduction in intraabdominal pressure corresponded to a significant decrease in Peak Inspiratory Pressures (PIP)
  • Each reduction in intraabdominal pressure corresponded to a significant decrease in Tidal Volume (TV)
8 October, 2019
Consecutive Retrospective
Same Day Discharge after Robotic Radical Prostatectomy
R Abaza, O Martinez, et al.
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  • Patient charges were significantly lower for patients that were discharged on the day of surgery with no increase in readmissions or emergency visits
1 August, 2019
Prospective Consecutive
Feasibility of Robot-Assisted Prostatectomy Performed at Ultra-Low Pneumoperitoneum Pressure of 6 mmHg and Comparison of Clinical Outcomes vs Standard Pressure of 15 mmHg
R Abaza, M Ferroni
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The 6mmHg group showed:
  • Patients had lower max pain scores between 5 and 12 hours
  • Fewer overall complications
  • The mean LOS was shorter (0.57 vs 1 day)
  • 43.3% of patients were discharged on the day of surgery
  • Fewer patients returned to the ER within 30 days
  • Fewer patients were readmitted within 30 days
2 January, 2019
Double Blinded Randomized Prospective
Reduction in Postoperative Ileus Rates Utilizing Lower Pressure Pneumoperitoneum in Robotic-assisted Radical Prostatectomy
M Rohloff, T Maatman, et al.
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Patients in the AirSeal at 12mmHg group:
  • Had a significantly shorter LOS
  • Showed lower occurrence of post-operative ileus (decreased from 12% to 5%)
19 May, 2018
Prospective Randomized Controlled Trial
Comparison of Valve-less and Standard Insufflation on Pneumoperitoneum-related Complications in Robotic Partial Nephrectomy: A Prospective Randomized Trial
T Feng, J Porter, et al.
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1 May, 2018
Consecutive Prospective
Low-Impact Laparoscopic Cholecystectomy is Associated with Decreased Postoperative Morbidity in Patients with Sickle Cell Disease
N de'Angelis, F Brunetti, et al.
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  • Low stable pneumoperitoneum pressure with AirSeal in sickle cell disease (SCD) patients is associated with a significantly reduced incidence of post-operative SCD-related morbidity
  • AirSeal allowed for rapid ambulation/return to regular diet without increasing the total cost per patient
31 December, 2017
Cqi
Laparoscopic Approach for the Treatment of Chronic Groin Pain After Inguinal Hernia Repair: Laparoscopic Approach for Inguinodynia
B Ramshaw, V Vetrano, et al.
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Patients in the group with AirSeal at low pressure and Exparel:
  • Were 7.81 times more likely to be discharged on the day of surgery
  • Were 80.5% less likely to develop a new type of groin pain after surgery
1 December, 2017
Prospective Single Center
Low Pressure Robot-assisted Radical Prostatectomy with the AirSeal® System at OLV Hospital: Results from a Prospective Study
A Mottrie, G Vandenbroucke, et al.
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  • Central venous pressure and mean airway pressure showed improvements when AirSeal was used
1 June, 2017
Prospective Parallel
A Prospective, Randomized, Clinical Trial on the Effects of a Valveless Trocar on Respiratory Mechanics During Robotic Radical Cystectomy: A Pilot Study
M Covotta, C Claroni, et al.
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Patients in the AirSeal group showed:
  • Lower inspiratory plateau pressure (Pplat)
  • Lower minute volume (MV)
  • Lower etCO2
  • Significantly higher static compliance (Cstat)
1 February, 2017
Prospective Randomized
Low Pressure Gynecological Laparoscopy (7mmHg) with AirSeal® System vs Standard Insufflation (15mmHg): A Pilot Study in 60 Patients
J-L Benifla, J Sroussi, et al.
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Patients in the AirSeal group:
  • Experienced both a lower incidence and severity of post-operative pain
  • Had lower maximal peak airway pressure
  • Had lower maximal etCO2
  • Had a lower maximal systolic blood pressure
  • Twice as many patients in the AirSeal group were discharged on the day of surgery (46.7% vs. 23.3%)
26 October, 2016
Cqi
A Clinical Quality Improvement (CQI) Project to Improve Pain After Laparoscopic Ventral Hernia Repair
B Ramshaw, B Forman, et al.
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  • Patients in AirSeal + Exparel group had a shorter length of stay in hospital
  • Procedures in AirSeal + Exparel group were 25% shorter in duration (101 minutes vs. 135 minutes)
5 August, 2016
Consecutive Prospective
Robotic Partial Nephrectomy Performed with AirSeal® vs a Standard CO2 Pressure Pneumoperitoneum Insufflator: A Prospective Comparative Study
F Annino, L Topazio, et al.
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The AirSeal group showed:
  • Procedures were 10.8% shorter in duration
  • Warm ischemia time was 38.9% shorter
  • A significant increase in the number of cases performed as “zero ischemia” (clampless) was observed in the AirSeal group (20 vs 4 cases)
28 April, 2016
Prospective Randomized
Comparison of Pneumoperitoneum Stability Between a Valveless Trocar System and Conventional Insufflation: A Prospective Randomized Trial
J Landman, P Bucur, et al.
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Patients in the AirSeal group:
  • Had a pneumoperitoneum that was far more stable or less variable than patients in the Standard Insufflation group
  • Had a lower etC02 after 10 minutes of insufflation than patients in the SI group
1 April, 2016
Prospective Single Site
Improved Outcomes during Robotic Prostatectomy utilizing Airseal® Technology
M Yezdani, S Yu, et al.
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AirSeal group showed:
  • Significantly less operative time (146min vs. 167min)
  • Reduction in intraoperative blood loss (132ml vs. 215ml)
  • Pain scores at 6-12 hours post-op were significantly lower (3.3 vs. 4.1) than the SI group
25 August, 2015
Single Subject Case Study
Laparoscopic Toupet Fundoplication using an AirSeal® System and Anchor Port in a 1.8-kg Infant: A Technical Report
G Miyano, K Morita, et al.
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  • With the AirSeal iFS, there was no disruptive loss of pneumoperitoneum, which saves time and allows the operator to focus without distraction
  • The AirSeal iFS contributed to the successful completion of LTF in a 1.8kg infant
1 March, 2015
Single Site Retrospective
Utilization of a Novel Valveless Trocar System during Robotic-assisted Laparoscopic Prostatectomy
L Kavoussi, R Wimhofer, et al.
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  • Mean operative time decreased by 23.2 min in AirSeal group vs. SI group
1 January, 1
Cqi
Prospective Evaluation of Low Insufflation Pressure Cholecystectomy Using an Insufflation Management System vs Standard CO2 Pneumoperitoneum
D Telem, R Kikhia, et al.
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  • Patients in the AirSeal group had a LOS that was 34.7% shorter (19.6 vs 30 hours) than patients in the SI group
1 January, 1
Retrospective Randomized
Retrospective Study of the AirSeal® System for Laparoscopic Bariatric Surgery
B Needleman, J Rydlewicz, et al.
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The AirSeal group:
  • Saved 12.3 minutes on average, which saves about $345 per case on OR time
  • Had a mean EBL of 34.6cc compared to the VersaStep group which had a mean EBL of 45cc