AirSeal®Insufflation Trocar/CO2 Absorption Study

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02654808
• Collaborator: SurgiQuest, Inc. (Industry)
• Enrollment: 132
• Location: 1
• Arms: 4
• Actual Duration (Months): 12
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg.

The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Diseases	Device: AirSeal trocar; Device: Standard trocar	N/A

Detailed Description

Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity.

The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Comparison of CO2 Absorption During Gynecologic Laparoscopy Using the AirSeal® Valveless Trocar System Versus Standard Insufflation Trocars at Intra-abdominal Pressures of 10 mmHg and 15 mmHg - a Randomized Controlled Trial
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard trocar/ IAP 15 mmHg Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.	Device: Standard trocar; A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Active Comparator: Standard trocar/ IAP 10 mmHg Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.	Device: Standard trocar; A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Active Comparator: AirSeal trocar/ IAP 15 mmHg Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.	Device: AirSeal trocar; The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Active Comparator: AirSeal trocar/ IAP 10 mmHg Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.	Device: AirSeal trocar; The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.

Outcome Measures

Primary Outcome Measures

1. Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg [15 minutes & 60 minutes from surgery start time]

   This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used.

Secondary Outcome Measures

1. Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars [At the end of surgery (approximately 1 hour)]

   Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.

2. Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars [At the end of surgery (approximately 1 hour)]

   Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).

3. Median VAS Pain Score When Using AirSeal® Versus Standard Trocars [4 to 6 hours, and 12 to 23 hours following surgery]

   Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.

4. Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg [15 minutes & 60 minutes from surgery start time]

   This outcome is measured by calculating the CO2 elimination rate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure

• Able to understand the consenting process and willing to participate in study

Exclusion Criteria:

• Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities

• Emergent surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• SurgiQuest, Inc.

Investigators

• Principal Investigator: Timothy Ryntz, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 10, 2017

More Information

Publications

• Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.
• CONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.
• Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73.
• Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. Review.
• Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
• Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.
• Kandil TS, El Hefnawy E. Shoulder pain following laparoscopic cholecystectomy: factors affecting the incidence and severity. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):677-82. doi: 10.1089/lap.2010.0112.
• Motew M, Ivankovich AD, Bieniarz J, Albrecht RF, Zahed B, Scommegna A. Cardiovascular effects and acid-base and blood gas changes during laparoscopy. Am J Obstet Gynecol. 1973 Apr 1;115(7):1002-12.
• Ng CS, Gill IS, Sung GT, Whalley DG, Graham R, Schweizer D. Retroperitoneoscopic surgery is not associated with increased carbon dioxide absorption. J Urol. 1999 Oct;162(4):1268-72.
• Özdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warlé MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15. Review.
• Park JS, Ahn EJ, Ko DD, Kang H, Shin HY, Baek CH, Jung YH, Woo YC, Kim JY, Koo GH. Effects of pneumoperitoneal pressure and position changes on respiratory mechanics during laparoscopic colectomy. Korean J Anesthesiol. 2012 Nov;63(5):419-24. doi: 10.4097/kjae.2012.63.5.419. Epub 2012 Nov 16.
• Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5.
• Sefr R, Puszkailer K, Jagos F. Randomized trial of different intraabdominal pressures and acid-base balance alterations during laparoscopic cholecystectomy. Surg Endosc. 2003 Jun;17(6):947-50. Epub 2003 Mar 14.
• Tan PL, Lee TL, Tweed WA. Carbon dioxide absorption and gas exchange during pelvic laparoscopy. Can J Anaesth. 1992 Sep;39(7):677-81.
• Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.
• Wolf JS Jr, Monk TG, McDougall EM, McClennan BL, Clayman RV. The extraperitoneal approach and subcutaneous emphysema are associated with greater absorption of carbon dioxide during laparoscopic renal surgery. J Urol. 1995 Sep;154(3):959-63.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT02654808
• Other Study ID Numbers: AAAQ6474
• First Posted: Jan 13, 2016
• Last Update Posted: Sep 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Columbia University: Gynecology; Laparoscopy; Pneumoperitoneum; CO2 absorption

Study Results

Participant Flow

Arm/Group Title	Standard Trocar/ IAP 15 mmHg	Standard Trocar/ IAP 10 mmHg	AirSeal Trocar/ IAP 15 mmHg	AirSeal Trocar/ IAP 10 mmHg
Arm/Group Description	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Period Title: Overall Study
STARTED	33	33	33	33
COMPLETED	33	33	33	33
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Standard Trocar/ IAP 15 mmHg	Standard Trocar/ IAP 10 mmHg	AirSeal Trocar/ IAP 15 mmHg	AirSeal Trocar/ IAP 10 mmHg	Total
Arm/Group Description	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.	Total of all reporting groups
Overall Participants	33	33	33	33	132
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	33 100%	33 100%	33 100%	33 100%	132 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	33 100%	33 100%	33 100%	33 100%	132 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	3 9.1%	1 3%	9 27.3%	5 15.2%	18 13.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	1 3%	1 0.8%
Black or African American	9 27.3%	13 39.4%	8 24.2%	4 12.1%	34 25.8%
White	14 42.4%	12 36.4%	6 18.2%	17 51.5%	49 37.1%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	7 21.2%	7 21.2%	10 30.3%	6 18.2%	30 22.7%

Outcome Measures

1. Primary Outcome

Title	Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
Description	This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used.
Time Frame	15 minutes & 60 minutes from surgery start time

Outcome Measure Data

Analysis Population Description

132 patients were enrolled and randomized into 1 of 4 study arms: standard insufflation/IAP 10 (S/10), standard insufflation/IAP 15 (S/15), valveless insufflation/IAP 10 (V/10), valveless insufflation/IAP 15 (V/15).

Arm/Group Title	Standard Trocar/ IAP 15 mmHg	Standard Trocar/ IAP 10 mmHg	AirSeal Trocar/ IAP 15 mmHg	AirSeal Trocar/ IAP 10 mmHg
Arm/Group Description	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.	Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Measure Participants	31	32	32	33
Mean (Standard Deviation) [mL/(kg*min)]	3.96 (1.19)	4.05 (1.08)	4.04 (1.54)	3.97 (1.00)

2. Secondary Outcome

Title	Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Description	Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.
Time Frame	At the end of surgery (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

132 patients were enrolled and randomized with 33 patients per arm. The participants were women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.

Arm/Group Title	Standard 10	Standard 15	Valveless 10	Valveless 15
Arm/Group Description	Standard insufflation system 10mmHg	standard insufflation system 15 mmHg	Valveless insufflation system 10 mmHg	Valveless insufflation system 15 mmHg
Measure Participants	32	31	33	32
Baseline	10.0 (2.0)	10.0 (1.0)	10.0 (1.0)	10.0 (0.8)
At 15 minutes	8.0 (3.0)	8.0 (4.0)	10.0 (2.0)	10.0 (2.0)
At 30 minutes	8.0 (3.0)	8.0 (3.0)	9.0 (3.0)	9.0 (2.0)
Colpotomy	4.5 (4.0)	5.0 (4.0)	8.0 (4.0)	9.0 (2.0)
Overall	7.0 (3.0)	7.0 (2.0)	9.0 (2.0)	9.5 (1.8)

3. Secondary Outcome

Title	Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
Description	Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).
Time Frame	At the end of surgery (approximately 1 hour)

Outcome Measure Data

Analysis Population Description

Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.

Arm/Group Title	Standard 10	Standard 15	Valveless 10	Valveless 15
Arm/Group Description	Standard insufflation system 10mmHg	standard insufflation system 15 mmHg	Valveless insufflation system 10 mmHg	Valveless insufflation system 15 mmHg
Measure Participants	32	31	33	32
Count of Participants [Participants]	30 90.9%	30 90.9%	32 97%	32 97%

4. Secondary Outcome

Title	Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Description	Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.
Time Frame	4 to 6 hours, and 12 to 23 hours following surgery

Outcome Measure Data

Analysis Population Description

Post-operative shoulder pain of women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.

Arm/Group Title	Standard 10	Standard 15	Valveless 10	Valveless 15
Arm/Group Description	Standard insufflation system 10mmHg	standard insufflation system 15 mmHg	Valveless insufflation system 10 mmHg	Valveless insufflation system 15 mmHg
Measure Participants	32	31	33	32
PACU arrival	0 (0)	0 (0)	0 (0)	0 (0)
PACU discharge	0 (2)	0 (0)	0 (4)	0 (1)
Post-operative Day #1	0 (4)	0 (4)	0 (4)	0 (5)
4 to 6 hours	0 (5)	0 (0)	0 (0)	0 (9)
12 to 23 hours	0 (0)	0 (0)	0 (2)	1.5 (7)

5. Secondary Outcome

Title	Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
Description	This outcome is measured by calculating the CO2 elimination rate.
Time Frame	15 minutes & 60 minutes from surgery start time

Outcome Measure Data

Analysis Population Description

Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.

Arm/Group Title	Standard 10	Standard 15	Valveless 10	Valveless 15
Arm/Group Description	Standard insufflation system 10mmHg	standard insufflation system 15 mmHg	Valveless insufflation system 10 mmHg	Valveless insufflation system 15 mmHg
Measure Participants	32	31	33	32
Mean (Standard Deviation) [mL/(kg*min)]	4.05 (1.08)	3.96 (1.19)	3.97 (1.00)	4.04 (1.54)

Adverse Events

Time Frame	Up to 1 day following surgery
Arm/Group Title	Standard Trocar/ IAP 15 mmHg		Standard Trocar/ IAP 10 mmHg		AirSeal Trocar/ IAP 15 mmHg		AirSeal Trocar/ IAP 10 mmHg
Arm/Group Description	Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.		Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.		Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.		Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
All Cause Mortality
	Standard Trocar/ IAP 15 mmHg		Standard Trocar/ IAP 10 mmHg		AirSeal Trocar/ IAP 15 mmHg		AirSeal Trocar/ IAP 10 mmHg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)
Serious Adverse Events
	Standard Trocar/ IAP 15 mmHg		Standard Trocar/ IAP 10 mmHg		AirSeal Trocar/ IAP 15 mmHg		AirSeal Trocar/ IAP 10 mmHg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Standard Trocar/ IAP 15 mmHg		Standard Trocar/ IAP 10 mmHg		AirSeal Trocar/ IAP 15 mmHg		AirSeal Trocar/ IAP 10 mmHg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.