Nano-Ceramic Coating for Laparoscope Lens

Laparoscopic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704259
• Other study ID #: ZagazigELSU
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient requiring laparoscopic operation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Elsharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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