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

Not Applicable

Terminated

• Conditions: Benign Female Reproductive System Neoplasm
• Interventions: Procedure: Steep Trendelenburg; Procedure: Decreased Trendelenburg

• Registration Number: NCT02728999
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2016-07-20
• Study Completion: 2016-07-20
• Status Verified: 2018-01
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Steep Trendelenburg	Steep Trendelenburg
Group B	Decreased Trendelenburg	Decreased Trendelenburg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Outcomes- Mean arterial Pressure	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.
Cardiovascular Outcomes- Heart rate	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.
Respiratory Parameter- arterial CO2	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.
Respiratory Outcomes- End Tidal CO2	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.
Respiratory Outcomes- Peak Airway Pressure	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.
Estimated Blood Loss	0-240 minutes	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	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.
Conversion of surgical approach	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.
Operative Time	1-240 minutes	The operative time will be measured (minutes) from the time the robot was docked until it is undocked.

Trial Locations

Locations (1)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States