Gynecologic Diseases Clinical Trial
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
NCT number | NCT02654808 |
Other study ID # | AAAQ6474 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | May 2017 |
Verified date | August 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | SurgiQuest, Inc. |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg | 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. | 15 minutes & 60 minutes from surgery start time | |
Secondary | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy. | At the end of surgery (approximately 1 hour) | |
Secondary | Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars | Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2). | At the end of surgery (approximately 1 hour) | |
Secondary | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery. | 4 to 6 hours, and 12 to 23 hours following surgery | |
Secondary | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg | This outcome is measured by calculating the CO2 elimination rate. | 15 minutes & 60 minutes from surgery start time |
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