AirSeal®Insufflation Trocar/CO2 Absorption Study
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2019 |
| Start Date: | May 2016 |
| End Date: | May 2017 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-4973
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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