A Single Center, Prospective, Randomized, Controlled Study to Evaluate Shoulder Pain, Cardiovascular Changes, Pulmonary Pressures and Perioperative Outcomes Related to the Use of the AirSeal® Insufflation System (AIS) at Low and Higher Pressure Pneumoperitoneum vs. Conventional Insufflation
Status: Withdrawn
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). Insufflation is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Time Frame
Start Date:2018-07
Completion Date:2022-07
Treatments
Experimental: Conventional Insufflation System (CIS)
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.
Experimental: ConMed AirSeal Insufflation System (AIS) at Low Pressure
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.
Active_comparator: 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.~ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.