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AirSeal®Insufflation Trocar/CO2 Absorption Study

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ClinicalTrials.gov Identifier: NCT02654808
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
SurgiQuest, Inc.
Information provided by (Responsible Party):
Columbia University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : May 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Difference in carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® versus standard trocars at intra-abdominal pressures of 10 mmHg [ Time Frame: 15 minutes & 60 minutes from surgery start time ]
    This outcome is measured by calculating the CO2 elimination rate.


Secondary Outcome Measures :
  1. Difference in Surgeon Questionnaire Score when using AirSeal® versus standard trocars [ Time Frame: At the end of surgery ]
    Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.

  2. Difference in Anesthesia Questionnaire Score when using AirSeal® versus standard trocars [ Time Frame: At the end of surgery ]
    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. Difference in VAS Pain Score when using AirSeal® versus standard trocars [ Time Frame: 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. Difference in carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® versus standard trocars at intra-abdominal pressures of 15 mmHg [ Time Frame: 15 minutes & 60 minutes from surgery start time ]
    This outcome is measured by calculating the CO2 elimination rate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654808


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
SurgiQuest, Inc.
Investigators
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Principal Investigator: Timothy Ryntz, MD Columbia University

Publications:
CONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02654808     History of Changes
Other Study ID Numbers: AAAQ6474
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Columbia University:
Gynecology
Laparoscopy
Pneumoperitoneum
CO2 absorption

Additional relevant MeSH terms:
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Genital Diseases, Female