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Spots Global Cancer Trial Database for Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

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Trial Identification

Brief Title: Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

Official Title: Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

Study ID: NCT02728999

Study Description

Brief Summary: Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital. Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees. Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.

Detailed Description: For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy. The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Advocate Lutheran General Hospital, Park Ridge, Illinois, United States

Contact Details

Name: Kirsten Sasaki, MD

Affiliation: Advocate Lutheran General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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