AirSeal®Insufflation Trocar/CO2 Absorption Study

Not Applicable

Completed

• Conditions: Gynecologic Diseases
• Interventions: Device: Standard trocar; Device: AirSeal trocar

• Registration Number: NCT02654808
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Study Start: 2016-05
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Results First Submitted: 2019-03-24
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Results First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard trocar/ IAP 10 mmHg	Standard trocar	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/ IAP 15 mmHg	Standard trocar	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.
AirSeal trocar/ IAP 15 mmHg	AirSeal trocar	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/ IAP 10 mmHg	AirSeal trocar	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).
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.
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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States