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

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.

Study Overview

• Status: Terminated
• Conditions: Benign Female Reproductive System Neoplasm
• Intervention / Treatment: Procedure: Steep Trendelenburg; Procedure: Decreased Trendelenburg

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Steep Trendelenburg	Procedure: Steep Trendelenburg; •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.; Other Names: Arterial Line in Wrist
Experimental: Group B; Decreased Trendelenburg	Procedure: Decreased Trendelenburg; •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.; Other Names: Arterial Line in Wrist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Advocate Health Care
• Investigators: Principal Investigator: Kirsten Sasaki, MD, Advocate Lutheran General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 20, 2016
• Study Completion (Actual): July 20, 2016

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Trendelenburg position; Robotic assisted gynecologic procedures; benign gynecologic conditions
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female
• Other Study ID Numbers: AHCIRB 5589 Trendelenburg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Manuscript and conference presentation
• IPD Sharing Time Frame: Data will be available starting 2/2018 for 6 months
• IPD Sharing Access Criteria: Any person that requests analyzed data.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)