Pneumoperitoneum Management With Low vs. Higher Pressure
Malignant Neoplasms of Female Genital Organs
About this trial
This is an interventional treatment trial for Malignant Neoplasms of Female Genital Organs focused on measuring Malignant Neoplasms of Female Genital Organs, Laparoscopic gynecologic surgery, Robotic gynecologic surgery, AirSeal® Insufflation System, AIS, Conventional Insufflation System, CIS, Questionnaires, Surveys
Eligibility Criteria
Inclusion Criteria:
- All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
- 18-80 years of age
- Capable and willing to provide Informed consent
- Acceptable candidate for laparoscopic/robotic GYN surgery as per discretion of the surgeon
- If patient agrees to participate in the optional patient reported outcomes portion of the study, patient must be English speaking and willing to complete the MD Anderson Symptom Inventory (MDASI) questionnaires
Exclusion Criteria:
- Active cutaneous infection or inflammation
- Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids
- Uncontrolled diabetes mellitus
- Severe co-existing morbidities having a life expectancy of less than 30 days
- Significant anemia with hemoglobin level less than 7 g/dL or a hematocrit less than 21%
- Females who are pregnant or lactating
- Patients presenting with ascites
- Patients with Chronic Pain Syndrome or requiring/using chronic pain medications
- Patients undergoing diagnostic laparoscopy
- Patients planning to undergo hand-assisted laparoscopy
- Severe comorbidities (atrial fibrillation, pulmonary hypertension, etc...)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Conventional Insufflation System (CIS)
ConMed AirSeal Insufflation System (AIS) at Low Pressure
ConMed AirSeal Insufflation System (AIS) at Higher Pressure
Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Conventional Insufflation System (CIS) used for pneumoperitoneum during laparoscopic/robotic surgery.
Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Low Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.
Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.