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Completed

NCT Number: NCT03438890

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

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.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warm saline

Device

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

Device

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

Device

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).

Primary outcomes

  1. the severity of LLF during the first 3-min operation

    Time frame: At the time of surgery

    The severity of LLF was rated on a scale of 0 (the clearest) to 10 (the foggiest).

Secondary outcomes

  1. the severity of LLF occurred during the remaining operative time except the first 3-min

    Time frame: At the time of surgery

    The severity of LLF was rated on a scale of 0 (the clearest) to 10 (the foggiest).

  2. the number of lens cleansing

    Time frame: At the time of surgery

    We will assess the number of lens cleansing at the time of surgery.

  3. total time to spend for lens cleaning

    Time frame: At the time of surgery

    We will assess the total time to spend for lens cleansing at the time of surgery.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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