Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
- Conditions
- Vaginal SurgeryLaparoscopic Surgery
- Interventions
- Device: Bean BagDevice: Pink PadDevice: Gel Pad
- Registration Number
- NCT03573557
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 159
- Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
- Patients must not be pregnant
- Pregnancy
- Patients unable to give consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bean Bag Bean Bag The Bean Bag will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. Pink Pad Pink Pad The Pink Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. Gel Pad Gel Pad The Gel Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg determine how much slipping is happening during the procedure.
- Primary Outcome Measures
Name Time Method Length of displacement when in Trendelenburg 1 day Normal amount of displacement when place in Trendelenburg
- Secondary Outcome Measures
Name Time Method Cost of device 1 day How cost effective is each surface
Patient BMI 1 day Influence of patient BMI on displacement per anti-slip surface
Rank of ease of use by physician 1 day Surgeon will rate how the surface interferes with surgery
Number of adverse events 1 day Count of adverse events per surface
Erythema score 1 day Erythema score per surface graded by skin redness
Patient age 1 day Influence of patient age on displacement per anti-slip surface
Patient weight 1 day Influence of patient weight on displacement per anti-slip surface
Patient height 1 day Influence of patient height on displacement per anti-slip surface
Patient Hip circumference 1 day Influence of patient hip circumference on displacement per anti-slip surface
Patient Waist circumference 1 day Influence of patient waist circumference on displacement per anti-slip surface
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States