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

• ClinicalTrials.gov Identifier: NCT02728999
• Recruitment Status: Terminated
• First Posted: April 6, 2016
• Last Update Posted: January 23, 2018
• Sponsor: Advocate Health Care
• Information provided by (Responsible Party): Kirsten Sasaki, MD, Advocate Health Care

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.

Condition or disease	Intervention/treatment	Phase
Benign Female Reproductive System Neoplasm	Procedure: Steep Trendelenburg; Procedure: Decreased Trendelenburg	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?
• Study Start Date: June 2013
• Actual Primary Completion Date: July 20, 2016
• Actual Study Completion Date: July 20, 2016

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: Arterial Line in Wrist

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Cardiovascular Outcomes- Heart rate [ Time Frame: 0-240 minutes ]
   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.
2. Respiratory Parameter- arterial CO2 [ Time Frame: 0-240 minutes ]
   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.
3. Respiratory Outcomes- End Tidal CO2 [ Time Frame: 0-240 minutes ]
   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.
4. Respiratory Outcomes- Peak Airway Pressure [ Time Frame: 0-240 minutes ]
   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.
5. Cardiovascular Outcomes- Mean arterial Pressure [ Time Frame: 0-240 minutes ]
   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.
6. Operative Time [ Time Frame: 1-240 minutes ]
   The operative time will be measured (minutes) from the time the robot was docked until it is undocked.
7. Estimated Blood Loss [ Time Frame: 0-240 minutes ]
   The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure.
8. Redocking of the robot [ Time Frame: 0-240 minutes ]
   It will be recorded whether the robot required undocking, placement in greater Trendelenburg and redocking of the robot in order to complete the procedure.
9. Conversion of surgical approach [ Time Frame: 0-240 minutes ]
   It will be recorded whether the surgical approach was transitioned to traditional laparoscopy or laparotomy versus a robotic-assisted procedure as scheduled.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Illinois

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

Sponsors and Collaborators

Advocate Health Care

Investigators

• Principal Investigator: Kirsten Sasaki, MD; Advocate Lutheran General Hospital

More Information

• Responsible Party: Kirsten Sasaki, MD, Advocate Health Care
• ClinicalTrials.gov Identifier: NCT02728999
• Other Study ID Numbers: AHCIRB 5589 Trendelenburg
• First Posted: April 6, 2016
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

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

Keywords provided by Kirsten Sasaki, MD, Advocate Health Care:

Trendelenburg position; Robotic assisted gynecologic procedures; benign gynecologic conditions

Additional relevant MeSH terms:

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms