Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03573557
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: