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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573557
• Other study ID #: CASE4817
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: March 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Vaginal Surgery

Intervention

Device:
• Pink Pad
Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
• Bean Bag
Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
• Gel Pad
Gel Pad used for patients in steep Trendelenburg position during surgery.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of displacement when in Trendelenburg	Normal amount of displacement when place in Trendelenburg	1 day
Secondary	Cost of device	How cost effective is each surface	1 day
Secondary	Rank of ease of use by physician	Surgeon will rate how the surface interferes with surgery	1 day
Secondary	Number of adverse events	Count of adverse events per surface	1 day
Secondary	Erythema score	Erythema score per surface graded by skin redness	1 day
Secondary	Patient BMI	Influence of patient BMI on displacement per anti-slip surface	1 day
Secondary	Patient age	Influence of patient age on displacement per anti-slip surface	1 day
Secondary	Patient weight	Influence of patient weight on displacement per anti-slip surface	1 day
Secondary	Patient height	Influence of patient height on displacement per anti-slip surface	1 day
Secondary	Patient Hip circumference	Influence of patient hip circumference on displacement per anti-slip surface	1 day
Secondary	Patient Waist circumference	Influence of patient waist circumference on displacement per anti-slip surface	1 day