NCT03438890

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gynecologic Disease

Interventions

Type	Name	Description
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.
DEVICE	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.
DEVICE	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).

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-10-11
• Completion: 2018-11-01
• First posted: 2018-02-20
• Last updated: 2019-08-28

Locations

1 site across 1 country: South Korea