N/A
N=132
AirSeal®Insufflation Trocar/CO2 Absorption Study
Gynecologic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02654808 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg — 3.96; 4.05; 4.04; 3.97 mL/(kg*min)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AirSeal trocar (Device); Standard trocar (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg |
3.96; 4.05; 4.04; 3.97 | — |
| SECONDARY Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars |
10.0; 10.0; 10.0; 10.0; 8.0; 8.0 | — |
| SECONDARY Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars |
30; 30; 32; 32 | — |
| SECONDARY Median VAS Pain Score When Using AirSeal® Versus Standard Trocars |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg |
4.05; 3.96; 3.97; 4.04 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02654808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.