AirSeal®Insufflation Trocar/CO2 Absorption Study

Columbia University

Status: Completed

Conditions: Gynecologic Diseases

Treatments: Device: AirSeal trocar; Device: Standard trocar

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02654808

AAAQ6474

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

Standard trocar/ IAP 15 mmHg

Active Comparator 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.

Treatment:

Device: Standard trocar

Standard trocar/ IAP 10 mmHg

Active Comparator 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 10 mmHg.

Treatment:

Device: Standard trocar

AirSeal trocar/ IAP 15 mmHg

Active Comparator group

Description:

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.

Treatment:

Device: AirSeal trocar

AirSeal trocar/ IAP 10 mmHg

Active Comparator group

Description:

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.

Treatment:

Device: AirSeal trocar