NCT03573557

Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vaginal Surgery
• Laparoscopic Surgery

Interventions

Type	Name	Description
DEVICE	Pink Pad	Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
DEVICE	Bean Bag	Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
DEVICE	Gel Pad	Gel Pad used for patients in steep Trendelenburg position during surgery.

Timeline

• Start date: 2018-06-05
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2018-06-29
• Last updated: 2022-03-23

Locations

1 site across 1 country: United States