Nano-Ceramic Coating for Laparoscope Lens

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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgical Procedures
• Intervention / Treatment: Other: Ceramic coating

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Egypt
  • Elsharkia
    • Zagazig, Elsharkia, Egypt, 44511
      • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted for laparoscopic operations

Description

Inclusion Criteria:

• Any patient requiring laparoscopic operation

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of fogging or smearing (per hour)	The investigator calculates the number of times the lens is visibly fogged or smeared per hour of operation.	One month
rate of fogging or smearing (per single operation)	The investigator calculates the number of times the lens is visibly fogged or smeared during a single operation.	One month
rate of extraction for cleaning (per hour)	The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per hour of operation.	One month
Rate of extraction for cleaning (per operation)	The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per single operation.	One month
The time consumption for lens cleaning (per hour)	The investigator calculates the time consumption of the cleaning process as a total (in minutes) per hour.	One month
The time consumption for lens cleaning (per single operation)	The investigator calculates the time consumption of the cleaning process as a total (in minutes) per single operation.	One month
Cleaning difficulty (per hour)	The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour	One month
Cleaning difficulty (per single operation)	The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affecting the lens function	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	One month

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

General Publications

• Manning TG, Papa N, Perera M, McGrath S, Christidis D, Khan M, O'Beirne R, Campbell N, Bolton D, Lawrentschuk N. Laparoscopic lens fogging: solving a common surgical problem in standard and robotic laparoscopes via a scientific model. Surg Endosc. 2018 Mar;32(3):1600-1606. doi: 10.1007/s00464-017-5772-x. Epub 2017 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ZagazigELSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes