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

Wake Forest University (WFU)

Status: Terminated

Conditions: Benign Female Reproductive System Neoplasm

Treatments: Procedure: Decreased Trendelenburg; Procedure: Steep Trendelenburg

Study type: Interventional

Funder types: Other

Identifiers

NCT02728999

AHCIRB 5589 Trendelenburg

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Group A

Other group

Description:

Steep Trendelenburg

Treatment:

Procedure: Steep Trendelenburg

Group B

Experimental group

Description:

Decreased Trendelenburg

Treatment:

Procedure: Decreased Trendelenburg