To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.
Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
159
Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
Gel Pad used for patients in steep Trendelenburg position during surgery.
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Length of displacement when in Trendelenburg
Normal amount of displacement when place in Trendelenburg
Time frame: 1 day
Cost of device
How cost effective is each surface
Time frame: 1 day
Rank of ease of use by physician
Surgeon will rate how the surface interferes with surgery
Time frame: 1 day
Number of adverse events
Count of adverse events per surface
Time frame: 1 day
Erythema score
Erythema score per surface graded by skin redness
Time frame: 1 day
Patient BMI
Influence of patient BMI on displacement per anti-slip surface
Time frame: 1 day
Patient age
Influence of patient age on displacement per anti-slip surface
Time frame: 1 day
Patient weight
Influence of patient weight on displacement per anti-slip surface
Time frame: 1 day
Patient height
Influence of patient height on displacement per anti-slip surface
Time frame: 1 day
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Patient Hip circumference
Influence of patient hip circumference on displacement per anti-slip surface
Time frame: 1 day
Patient Waist circumference
Influence of patient waist circumference on displacement per anti-slip surface
Time frame: 1 day