Nano-Ceramic Coating for Laparoscope Lens

Completed

• Conditions: Laparoscopic Surgical Procedures

• Registration Number: NCT03704259
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Any patient requiring laparoscopic operation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of fogging or smearing (per hour)	One month	The investigator calculates the number of times the lens is visibly fogged or smeared per hour of operation.
The time consumption for lens cleaning (per single operation)	One month	The investigator calculates the time consumption of the cleaning process as a total (in minutes) per single operation.
rate of extraction for cleaning (per hour)	One month	The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per hour of operation.
The time consumption for lens cleaning (per hour)	One month	The investigator calculates the time consumption of the cleaning process as a total (in minutes) per hour.
rate of fogging or smearing (per single operation)	One month	The investigator calculates the number of times the lens is visibly fogged or smeared during a single operation.
Rate of extraction for cleaning (per operation)	One month	The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per single operation.
Cleaning difficulty (per hour)	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
Cleaning difficulty (per single operation)	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 Outcome Measures

Name	Time	Method
Affecting the lens function	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: 1. coated lens is notably better (significant difference); 2. coated lens is slightly better (negligible difference); 3. non-coated lens is notably better (significant difference); 4. non-coated lens is slightly better (negligible difference); 5. no difference

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Elsharkia, Egypt