A Randomized-Controlled Trial of Conventional Pneumoinsufflation and Pressure-Barrier Insufflation at High and Low Pressures in Gynecologic Surgery
Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study seeks to evaluate post-operative patient pain and quality of life, and intra-operative hemodynamic status and changes in inflammatory markers, with use of a pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum pressure settings.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Subjects must meet the following inclusion criteria to be eligible for the study.
‣ Understand and voluntarily sign an informed consent form.
⁃ Female gender ages 18-65
⁃ Scheduled for total laparoscopic hysterectomy for benign indications with or without oophorectomy (standard of care involves bilateral salpingectomy).
Locations
United States
Florida
Cleveland Clinic Florida
Weston
Time Frame
Start Date: 2016-10
Completion Date: 2021-12
Participants
Target number of participants: 80
Treatments
Active_comparator: Standard High Pressure (15mmHg)
Pneumoinsufflator mode and setting: standard at 15mmHg
Experimental: AirSeal High Pressure (15mmHg)
Pneumoinsufflator mode and setting: pressure-barrier at 15mmHg
Experimental: Standard Low Pressure (9mmHg)
Pneumoinsufflator mode and setting: standard at 9mmHg
Experimental: AirSeal Low Pressure (9mmHg)
Pneumoinsufflator mode and setting: pressure-barrier at 9 mmHg
Authors
Sponsors
Leads: The Cleveland Clinic
Collaborators: CONMED Corporation