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OpenTrials
Completed

NCT Number: NCT03573557

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pink Pad

Device

Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.

Bean Bag

Device

Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.

Gel Pad

Device

Gel Pad used for patients in steep Trendelenburg position during surgery.

Primary outcomes

  1. Length of displacement when in Trendelenburg

    Time frame: 1 day

    Normal amount of displacement when place in Trendelenburg

Secondary outcomes

  1. Cost of device

    Time frame: 1 day

    How cost effective is each surface

  2. Rank of ease of use by physician

    Time frame: 1 day

    Surgeon will rate how the surface interferes with surgery

  3. Number of adverse events

    Time frame: 1 day

    Count of adverse events per surface

  4. Erythema score

    Time frame: 1 day

    Erythema score per surface graded by skin redness

  5. Patient BMI

    Time frame: 1 day

    Influence of patient BMI on displacement per anti-slip surface

  6. Patient age

    Time frame: 1 day

    Influence of patient age on displacement per anti-slip surface

  7. Patient weight

    Time frame: 1 day

    Influence of patient weight on displacement per anti-slip surface

  8. Patient height

    Time frame: 1 day

    Influence of patient height on displacement per anti-slip surface

  9. Patient Hip circumference

    Time frame: 1 day

    Influence of patient hip circumference on displacement per anti-slip surface

  10. Patient Waist circumference

    Time frame: 1 day

    Influence of patient waist circumference on displacement per anti-slip surface

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2018
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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