Clinical trial NCT02728999: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Female Reproductive System Neoplasm
Keywords: Trendelenburg position
Robotic assisted gynecologic procedures
benign gynecologic conditions
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* all women at Lutheran General Hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study.
* Women who are 18 years or older on the day of surgery.
* Patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery.

Exclusion Criteria:

* pregnant women
* Anyone who is less than 18 years old on the day of surgery.
* Anyone who does not have the capacity to make independent medical decisions.

Primary outcomes:
measure: • Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Cardiovascular Outcomes- Heart rate
timeFrame: 0-240 minutes
measure: Respiratory Parameter- arterial CO2
timeFrame: 0-240 minutes
measure: Respiratory Outcomes- End Tidal CO2
timeFrame: 0-240 minutes
measure: Respiratory Outcomes- Peak Airway Pressure
timeFrame: 0-240 minutes
measure: Cardiovascular Outcomes- Mean arterial Pressure
timeFrame: 0-240 minutes
measure: Operative Time
timeFrame: 1-240 minutes
measure: Estimated Blood Loss
timeFrame: 0-240 minutes
measure: Redocking of the robot
timeFrame: 0-240 minutes
measure: Conversion of surgical approach
timeFrame: 0-240 minutes
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Advocate Lutheran General Hospital
name: Kirsten Sasaki, MD
role: PRINCIPAL_INVESTIGATOR
References: