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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Vaginal Surgery
• Intervention / Treatment: Device: Pink Pad; Device: Bean Bag; Device: Gel Pad

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pink Pad; 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.	Device: Pink Pad; Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
Active Comparator: Bean Bag; 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.	Device: Bean Bag; Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
Active Comparator: Gel Pad; 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.	Device: Gel Pad; Gel Pad used for patients in steep Trendelenburg position during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of displacement when in Trendelenburg	Normal amount of displacement when place in Trendelenburg	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of device	How cost effective is each surface	1 day
Rank of ease of use by physician	Surgeon will rate how the surface interferes with surgery	1 day
Number of adverse events	Count of adverse events per surface	1 day
Erythema score	Erythema score per surface graded by skin redness	1 day
Patient BMI	Influence of patient BMI on displacement per anti-slip surface	1 day
Patient age	Influence of patient age on displacement per anti-slip surface	1 day
Patient weight	Influence of patient weight on displacement per anti-slip surface	1 day
Patient height	Influence of patient height on displacement per anti-slip surface	1 day
Patient Hip circumference	Influence of patient hip circumference on displacement per anti-slip surface	1 day
Patient Waist circumference	Influence of patient waist circumference on displacement per anti-slip surface	1 day

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Sherif El-Nashar, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CASE4817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No