Clinical trial NCT02654808: AirSeal®Insufflation Trocar/CO2 Absorption Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Diseases
Keywords: Gynecology
Laparoscopy
Pneumoperitoneum
CO2 absorption
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: SurgiQuest, Inc.
First posted: 2016-01-13
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
timeFrame: 15 minutes & 60 minutes from surgery start time
Secondary outcomes:
measure: Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
timeFrame: At the end of surgery (approximately 1 hour)
measure: Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
timeFrame: At the end of surgery (approximately 1 hour)
measure: Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
timeFrame: 4 to 6 hours, and 12 to 23 hours following surgery
measure: Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
timeFrame: 15 minutes & 60 minutes from surgery start time
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Timothy Ryntz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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