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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Laparoscopic Surgery; Vaginal Surgery

Treatments: Device: Bean Bag; Device: Pink Pad; Device: Gel Pad

Study type: Interventional

Funder types: Other

Identifiers

NCT03573557

CASE4817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

159 participants in 3 patient groups

Pink Pad

Active Comparator group

Description:

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.

Treatment:

Device: Pink Pad

Bean Bag

Active Comparator group

Description:

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.

Treatment:

Device: Bean Bag

Gel Pad

Active Comparator group

Description:

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.

Treatment:

Device: Gel Pad