Laparoscopic Lens Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution

Gynecologic Disease Clinical Trial

— CLEAR  

Official title:

Randomized Comparison of Laparoscopic LEns Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution (CLEAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438890
• Other study ID #: 2018-03-005
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: August 2019
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare three popular methods of minimizing or reducing laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

Description:

The physiology behind laparoscopic lens fogging (LLF) is well understood based on meticulous experiments outlining the role of temperature and humidity. Despite many efforts, including uses of warm saline, various anti-fog agents, chlorhexidine, betadine, and rubbing the lens on serosal surfaces, to reduce LLF, there remains no consensus as to which method is superior to prevent LLF. Furthermore, most previous studies were experimental trials conducted in a simulation model or a non-human in vivo model or an expert's commentary based on their clinical experiences , and there was no randomized controlled trial focusing LLF in human model. Therefore, this randomized trial aimed to compare three popular methods of minimizing or reducing LLF by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 1, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65 years

• American Society of Anesthesiologists physical status (ASAPS) classification I-II

• the absence of pregnancy at the time of surgery

Exclusion Criteria:

• allergy to chlorhexidine or anti-fog solution

• anticipating cases of abrupt change in intra-abdominal humidity such as hemoperitoneum and profuse ascites

• extremely short or long operative time (<20 min or > 180 min) affecting the frequency of LLF

• unavailability of the surgical recording equipment for laparoscopic procedure.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Device:
• Warm saline
In subjects allocated to the warm saline group, a thermos flask, which was filled with heated sterile water, was used. A 1000 ml bottle of sterile water was heated to 60 °C in a stove for an hour at minimum. Just before introducing into the abdominal cavity, the laparoscope was placed into the thermos flask for 30 seconds at minimum . After each incidence of laparoscopic lens fogging (LLF), the scope was briefly inserted into the thermos flask about 10 seconds, and was then wrapped gauze around the lens before abdominal reinsertion.
• anti-fog agent
In the anti-fog agent group, Ultra-Stop TM (Sigmaphrarm, Vienna, Austria), which is a commercial anti-fogging solution containing alcohol, surfactant, and water for medical optical devices, was used. Wiping the lens with gauze soaked in Ultra-Stop TM and allowing the surfactant to act for 5 seconds, the laparoscope was introduced into the abdominal cavity. After each laparoscopic lens fogging (LLF), the scope was removed from the abdomen and cleaned using the same corresponding method.
• chlorhexidine
In the chlorhexidine group, the lens was wiped with gauze soaked in 4% chlorhexidine detergent solution (Firson, Cheonan, Korea) for 5 seconds before introducing into the abdominal cavity, and chlorhexidine was reapplied on the lens at the occurrence of laparoscopic lens fogging (LLF).

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of LLF during the first 3-min operation	The severity of LLF was rated on a scale of 0 (the clearest) to 10 (the foggiest).	At the time of surgery
Secondary	the severity of LLF occurred during the remaining operative time except the first 3-min	The severity of LLF was rated on a scale of 0 (the clearest) to 10 (the foggiest).	At the time of surgery
Secondary	the number of lens cleansing	We will assess the number of lens cleansing at the time of surgery.	At the time of surgery
Secondary	total time to spend for lens cleaning	We will assess the total time to spend for lens cleansing at the time of surgery.	At the time of surgery