Gynecologic Diseases
Conditions
Keywords
Gynecology, Laparoscopy, Pneumoperitoneum, CO2 absorption
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.
Interventions
DEVICEAirSeal trocar
The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
DEVICEStandard trocar
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Sponsors
SurgiQuest, Inc.
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Trocar/ IAP 15 mmHg 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.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas. | 33 |
| Standard Trocar/ IAP 10 mmHg 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: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas. | 33 |
| AirSeal Trocar/ IAP 15 mmHg 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: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes. | 33 |
| AirSeal Trocar/ IAP 10 mmHg 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.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes. | 33 |
| Total | 132 |
Baseline characteristics
| Characteristic | Standard Trocar/ IAP 10 mmHg | AirSeal Trocar/ IAP 15 mmHg | Standard Trocar/ IAP 15 mmHg | AirSeal Trocar/ IAP 10 mmHg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 33 Participants | 33 Participants | 132 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 9 Participants | 3 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 8 Participants | 9 Participants | 4 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 7 Participants | 6 Participants | 30 Participants |
| Race (NIH/OMB) White | 12 Participants | 6 Participants | 14 Participants | 17 Participants | 49 Participants |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 33 Participants | 33 Participants | 132 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 33 |
Outcome results
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.
Time frame: 15 minutes & 60 minutes from surgery start time
Population: 132 patients were enrolled and randomized into 1 of 4 study arms: standard insufflation/IAP 10 (S/10), standard insufflation/IAP 15 (S/15), valveless insufflation/IAP 10 (V/10), valveless insufflation/IAP 15 (V/15).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Trocar/ IAP 15 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg | 3.96 mL/(kg*min) | Standard Deviation 1.19 |
| Standard Trocar/ IAP 10 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg | 4.05 mL/(kg*min) | Standard Deviation 1.08 |
| AirSeal Trocar/ IAP 15 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg | 4.04 mL/(kg*min) | Standard Deviation 1.54 |
| AirSeal Trocar/ IAP 10 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg | 3.97 mL/(kg*min) | Standard Deviation 1 |
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.
Time frame: 15 minutes & 60 minutes from surgery start time
Population: Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Trocar/ IAP 15 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg | 4.05 mL/(kg*min) | Standard Deviation 1.08 |
| Standard Trocar/ IAP 10 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg | 3.96 mL/(kg*min) | Standard Deviation 1.19 |
| AirSeal Trocar/ IAP 15 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg | 3.97 mL/(kg*min) | Standard Deviation 1 |
| AirSeal Trocar/ IAP 10 mmHg | Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg | 4.04 mL/(kg*min) | Standard Deviation 1.54 |
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.
Time frame: At the end of surgery (approximately 1 hour)
Population: 132 patients were enrolled and randomized with 33 patients per arm. The participants were women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Standard Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Colpotomy | 4.5 score on a scale from 0 to 10 | Standard Deviation 4 |
| Standard Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 15 minutes | 8.0 score on a scale from 0 to 10 | Standard Deviation 3 |
| Standard Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Overall | 7.0 score on a scale from 0 to 10 | Standard Deviation 3 |
| Standard Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 30 minutes | 8.0 score on a scale from 0 to 10 | Standard Deviation 3 |
| Standard Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Baseline | 10.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| Standard Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 30 minutes | 8.0 score on a scale from 0 to 10 | Standard Deviation 3 |
| Standard Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Colpotomy | 5.0 score on a scale from 0 to 10 | Standard Deviation 4 |
| Standard Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Overall | 7.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| Standard Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 15 minutes | 8.0 score on a scale from 0 to 10 | Standard Deviation 4 |
| Standard Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Baseline | 10.0 score on a scale from 0 to 10 | Standard Deviation 1 |
| AirSeal Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 30 minutes | 9.0 score on a scale from 0 to 10 | Standard Deviation 3 |
| AirSeal Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Baseline | 10.0 score on a scale from 0 to 10 | Standard Deviation 1 |
| AirSeal Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 15 minutes | 10.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Colpotomy | 8.0 score on a scale from 0 to 10 | Standard Deviation 4 |
| AirSeal Trocar/ IAP 15 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Overall | 9.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Colpotomy | 9.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 15 minutes | 10.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Baseline | 10.0 score on a scale from 0 to 10 | Standard Deviation 0.8 |
| AirSeal Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | At 30 minutes | 9.0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 10 mmHg | Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars | Overall | 9.5 score on a scale from 0 to 10 | Standard Deviation 1.8 |
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.
Time frame: 4 to 6 hours, and 12 to 23 hours following surgery
Population: Post-operative shoulder pain of women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Standard Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 4 to 6 hours | 0 score on a scale from 0 to 10 | Standard Deviation 5 |
| Standard Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU discharge | 0 score on a scale from 0 to 10 | Standard Deviation 2 |
| Standard Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 12 to 23 hours | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| Standard Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | Post-operative Day #1 | 0 score on a scale from 0 to 10 | Standard Deviation 4 |
| Standard Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU arrival | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| Standard Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | Post-operative Day #1 | 0 score on a scale from 0 to 10 | Standard Deviation 4 |
| Standard Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 4 to 6 hours | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| Standard Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 12 to 23 hours | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| Standard Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU discharge | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| Standard Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU arrival | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| AirSeal Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | Post-operative Day #1 | 0 score on a scale from 0 to 10 | Standard Deviation 4 |
| AirSeal Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU arrival | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| AirSeal Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU discharge | 0 score on a scale from 0 to 10 | Standard Deviation 4 |
| AirSeal Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 4 to 6 hours | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| AirSeal Trocar/ IAP 15 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 12 to 23 hours | 0 score on a scale from 0 to 10 | Standard Deviation 2 |
| AirSeal Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 4 to 6 hours | 0 score on a scale from 0 to 10 | Standard Deviation 9 |
| AirSeal Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU discharge | 0 score on a scale from 0 to 10 | Standard Deviation 1 |
| AirSeal Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | PACU arrival | 0 score on a scale from 0 to 10 | Standard Deviation 0 |
| AirSeal Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | Post-operative Day #1 | 0 score on a scale from 0 to 10 | Standard Deviation 5 |
| AirSeal Trocar/ IAP 10 mmHg | Median VAS Pain Score When Using AirSeal® Versus Standard Trocars | 12 to 23 hours | 1.5 score on a scale from 0 to 10 | Standard Deviation 7 |
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).
Time frame: At the end of surgery (approximately 1 hour)
Population: Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Trocar/ IAP 15 mmHg | Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars | 30 Participants |
| Standard Trocar/ IAP 10 mmHg | Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars | 30 Participants |
| AirSeal Trocar/ IAP 15 mmHg | Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars | 32 Participants |
| AirSeal Trocar/ IAP 10 mmHg | Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars | 32 Participants |