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Completed

NCT Number: NCT03704259

Nano-Ceramic Coating for Laparoscope Lens

The investigator tests the effectiveness of nano-ceramic coating when applied (painted) on laparoscope lens to protect it from fogging or smearing during laparoscopic operations

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University

Zagazig, Elsharkia, 44511, Egypt

About this study

A Ceramic Coating is a liquid polymer that is applied by hand to surfaces to make them resistant to scratching, staining, rust or oxidation, as well as "hydrophilic", meaning that water or mud doesn't stick to them and so, they become much easier to clean. It was publicly commercialized in recent years for use on automobiles to preserve their gloss, protect their paint, preserve the clarity of their wind shields and headlights so as to provide better lighting and vision.

On the other hand, lens fogging and other vision-obstructing events during laparoscopic or endoscopic operations(e.g. being smeared by blood or other body fluids during operation, or having a piece of loose tissue stick to its surface that require manual removal and wiping) have been an ever-lasting concern for operators ever since the advent of the respective devices. Many techniques and methods have developed, tested and compared regarding their effectiveness in protecting the lens from such events and preserving vision clear and uninterrupted during operations. Examples of such methods are (scope warmers, FREDTM, ResoclearTM, chlorhexidine, betadine and immersion in heated saline.

In this study the investigator seeks to apply the idea of nano-ceramic coating as a new technique for achieving that goal. to the investigator's best knowledge, this idea was never conceived or tested in the field before.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient requiring laparoscopic operation

Exclusion criteria

  • Any intra-operative event or obstacle that requires conversion to open surgery

Treatment and study plan

Ceramic coating

Other

coating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications

Other names: nan-ceramic coating

Primary outcomes

  1. rate of fogging or smearing (per hour)

    Time frame: One month

    The investigator calculates the number of times the lens is visibly fogged or smeared per hour of operation.

  2. rate of fogging or smearing (per single operation)

    Time frame: One month

    The investigator calculates the number of times the lens is visibly fogged or smeared during a single operation.

  3. rate of extraction for cleaning (per hour)

    Time frame: One month

    The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per hour of operation.

  4. Rate of extraction for cleaning (per operation)

    Time frame: One month

    The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per single operation.

  5. The time consumption for lens cleaning (per hour)

    Time frame: One month

    The investigator calculates the time consumption of the cleaning process as a total (in minutes) per hour.

  6. The time consumption for lens cleaning (per single operation)

    Time frame: One month

    The investigator calculates the time consumption of the cleaning process as a total (in minutes) per single operation.

  7. Cleaning difficulty (per hour)

    Time frame: One month

    The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour

  8. Cleaning difficulty (per single operation)

    Time frame: One month

    The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour

Secondary outcomes

  1. Affecting the lens function

    Time frame: One month

    This is a subjective assessment measure, represented by the operators' statement about whether coating the lens affected its vision I.E whether there is a difference in acuity of vision between the coated and the non-coated lens in the absence of any fogging or smearing.

    Statement is given as one of five choices:

    • coated lens is notably better (significant difference)
    • coated lens is slightly better (negligible difference)
    • non-coated lens is notably better (significant difference)
    • non-coated lens is slightly better (negligible difference)
    • no difference

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Nano-Ceramic Coating for Laparoscope Lens: a Cheap Magical Solution for Lens Fogging and Smearing

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2018
Registry last updated
Feb 7, 2020

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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