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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Female Reproductive System Neoplasm

Intervention / Treatment
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* Procedure: Steep Trendelenburg
* Procedure: Decreased Trendelenburg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Steep Trendelenburg | Procedure: Steep Trendelenburg<br>* •Subjects who undergo steep Trendelenburg will remain in 30 degrees of Trendelenburg, and the da Vinci robot will be docked. After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.<br>* Other names: Arterial Line in Wrist;|
| Experimental: Group B<br>Decreased Trendelenburg | Procedure: Decreased Trendelenburg<br>* •Subjects who undergo decreased Trendelenburg will be taken out of Trendelenburg to the minimal angle possible that enables adequate visualization, as determined by the primary surgeon, at which time robot will be docked. After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.<br>* Other names: Arterial Line in Wrist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms | Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30) | 0-240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Outcomes- Heart rate | Heart rate (beats per minute) measured in beats per minute by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and at the end of the case. | 0-240 minutes | 
| Respiratory Parameter- arterial CO2 | Arterial CO2- Measured by taking an arterial blood gas from the arterial line by the anesthesiologist at the beginning of the case prior to insufflation, and then every hour while in Trendelenburg. | 0-240 minutes | 
| Respiratory Outcomes- End Tidal CO2 | End Tidal CO2 measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case. | 0-240 minutes | 
| Respiratory Outcomes- Peak Airway Pressure | Peak Airway Pressure (mm Hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case. | 0-240 minutes | 
| Cardiovascular Outcomes- Mean arterial Pressure | Mean arterial pressure (mm hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case. | 0-240 minutes | 
| Operative Time | The operative time will be measured (minutes) from the time the robot was docked until it is undocked. | 1-240 minutes | 
| Estimated Blood Loss | The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure. | 0-240 minutes | 
| Redocking of the robot | It will be recorded whether the robot required undocking, placement in greater Trendelenburg and redocking of the robot in order to complete the procedure. | 0-240 minutes | 
| Conversion of surgical approach | It will be recorded whether the surgical approach was transitioned to traditional laparoscopy or laparotomy versus a robotic-assisted procedure as scheduled. | 0-240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trendelenburg position, Robotic assisted gynecologic procedures, benign gynecologic conditions