Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 18 years of age or older
• Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Rebecca Schneyer, MD
rebecca.schneyer@cshs.org
914-391-2604
Backup
Rebekah Odum, BSN
rebekah.odum@cshs.org
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2027-04
Participants
Target number of participants: 294
Treatments
Active_comparator: 15mmHg (Conventional Laparoscopic Arm)
Standard Pressure, Conventional Laparoscopic Arm
Experimental: 12mmHg (Conventional Laparoscopic Arm)
Lower Pressure, Conventional Laparoscopic Arm
Experimental: 10mmHg (Conventional Laparoscopic Arm)
Lowest Pressure, Conventional Laparoscopic Arm
Active_comparator: 15mmHg (Robotic-Assisted Laparoscopic Arm)
Standard Pressure, Robotic-Assisted Laparoscopic Arm
Experimental: 12mmHg (Robotic-Assisted Laparoscopic Arm)
Lower Pressure, Robotic-Assisted Laparoscopic Arm
Experimental: 10mmHg (Robotic-Assisted Laparoscopic Arm)
Lowest Pressure, Robotic-Assisted Laparoscopic Arm
Related Therapeutic Areas
Sponsors
Leads: Cedars-Sinai Medical Center