Laparoscopic Surgery, Vaginal Surgery
Conditions
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.
Interventions
DEVICEPink Pad
Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
DEVICEBean Bag
Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
DEVICEGel Pad
Gel Pad used for patients in steep Trendelenburg position during surgery.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center * Patients must not be pregnant
Exclusion criteria
* Pregnancy * Patients unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of displacement when in Trendelenburg | 1 day | Normal amount of displacement when place in Trendelenburg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 BMI | 1 day | Influence of patient BMI on displacement per anti-slip surface |
| Cost of device | 1 day | How cost effective is each 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 |
| Patient age | 1 day | Influence of patient age on displacement per anti-slip surface |
Countries
United States
Outcome results
None listed