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

Benign Female Reproductive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02728999
• Other study ID #: AHCIRB 5589 Trendelenburg
• Status: Terminated
• Phase: N/A
• First received: March 1, 2016
• Last updated: January 18, 2018
• Start date: June 2013
• Est. completion date: July 20, 2016

Study information

• Verified date: January 2018
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 20, 2016
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Female Reproductive System Neoplasm
• Genital Neoplasms, Female

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Operative Time	The operative time will be measured (minutes) from the time the robot was docked until it is undocked.	1-240 minutes
Secondary	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
Secondary	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
Secondary	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