Laparoscopic Surgical ProceduresNCT03704259
Nano-Ceramic Coating for Laparoscope Lens
An observational study of Laparoscopic Surgical Procedures, run by Zagazig University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Surgical Procedures
- What is being tested?
- Ceramic coating
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted for laparoscopic operations
Who may be able to join
- Any patient requiring laparoscopic operation
Who cannot join
- Any intra-operative event or obstacle that requires conversion to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Laparoscopic Surgical Procedures
- Being tested
- Ceramic coating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic coatingOther
Also called nan-ceramic coating
coating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: One month
Secondary outcomes (1)
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
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Sep 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, yousef ahmed el-ayman, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704259
- Sponsor's protocol ID
- ZagazigELSU
- Status last verified
- Feb 2020
- First submitted
- 12 Sep 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 28791559
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-Ceramic Coating for Laparoscope Lens: a Cheap Magical Solution for Lens Fogging and Smearing
- ClinicalTrials.gov ID
- NCT03704259
- Acronym / sponsor ID
- ZagazigELSU
- Conditions
- Laparoscopic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted for laparoscopic operations
Key inclusion criteria (1 listed)
- Any patient requiring laparoscopic operation
Key exclusion criteria (1 listed)
- Any intra-operative event or obstacle that requires conversion to open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceramic coatingAlso: nan-ceramic coatingcoating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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
1 secondary outcome
Affecting the lens function
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 28791559Manning 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgical Procedures, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of fogging or smearing (per hour) (time frame: One month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.