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

Primary Purpose

Benign Female Reproductive System Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Steep Trendelenburg
Decreased Trendelenburg
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Female Reproductive System Neoplasm focused on measuring Trendelenburg position, Robotic assisted gynecologic procedures, benign gynecologic conditions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Advocate Lutheran General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group A

Group B

Arm Description

Steep Trendelenburg

Decreased Trendelenburg

Outcomes

Primary Outcome Measures

• 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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
Operative Time
The operative time will be measured (minutes) from the time the robot was docked until it is undocked.
Estimated Blood Loss
The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure.
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.
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.

Full Information

First Posted
March 1, 2016
Last Updated
January 18, 2018
Sponsor
Advocate Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT02728999
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Did not want to expose additional subjects to Arterial Line placement
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 20, 2016 (Actual)
Study Completion Date
July 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Female Reproductive System Neoplasm
Keywords
Trendelenburg position, Robotic assisted gynecologic procedures, benign gynecologic conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Steep Trendelenburg
Arm Title
Group B
Arm Type
Experimental
Arm Description
Decreased Trendelenburg
Intervention Type
Procedure
Intervention Name(s)
Steep Trendelenburg
Other Intervention Name(s)
Arterial Line in Wrist
Intervention Description
•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.
Intervention Type
Procedure
Intervention Name(s)
Decreased Trendelenburg
Other Intervention Name(s)
Arterial Line in Wrist
Intervention Description
•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.
Primary Outcome Measure Information:
Title
• Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
Description
Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30)
Time Frame
0-240 minutes
Secondary Outcome Measure Information:
Title
Cardiovascular Outcomes- Heart rate
Description
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.
Time Frame
0-240 minutes
Title
Respiratory Parameter- arterial CO2
Description
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.
Time Frame
0-240 minutes
Title
Respiratory Outcomes- End Tidal CO2
Description
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.
Time Frame
0-240 minutes
Title
Respiratory Outcomes- Peak Airway Pressure
Description
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.
Time Frame
0-240 minutes
Title
Cardiovascular Outcomes- Mean arterial Pressure
Description
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.
Time Frame
0-240 minutes
Title
Operative Time
Description
The operative time will be measured (minutes) from the time the robot was docked until it is undocked.
Time Frame
1-240 minutes
Title
Estimated Blood Loss
Description
The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure.
Time Frame
0-240 minutes
Title
Redocking of the robot
Description
It will be recorded whether the robot required undocking, placement in greater Trendelenburg and redocking of the robot in order to complete the procedure.
Time Frame
0-240 minutes
Title
Conversion of surgical approach
Description
It will be recorded whether the surgical approach was transitioned to traditional laparoscopy or laparotomy versus a robotic-assisted procedure as scheduled.
Time Frame
0-240 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Sasaki, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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