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Trial record 4 of 1548 for:    Recruiting, Not yet recruiting, Available Studies | "Genital Diseases, Female"

Laparoscopic Lens Defogging Using Anti-fog Agent, waRm Solution, and Chlorhexidine (CLEAR)

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ClinicalTrials.gov Identifier: NCT03438890
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Taejong Song, Kangbuk Samsung Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Gynecologic Disease Device: Warm saline Device: anti-fog agent Device: chlorhexidine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Allocation information was hidden from the participants and outcome assessor.
Primary Purpose: Treatment
Official Title: Randomized Comparison of Laparoscopic LEns Defogging Using Anti-fog Agent, waRm Solution, and Chlorhexidine (CLEAR)
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021


Arm Intervention/treatment
Experimental: Warm saline group
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: 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.

Experimental: anti-fog agent group
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: 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.

Experimental: chlorhexidine group
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).
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).

No Intervention: control group
In the control group, the lens was not wiped gauze or applied any solution before use of the laparoscope. When occurred the event of each laparoscopic lens fogging (LLF) that splatter of irrigation fluid, blood, and body fluids affected visual clearance, the laparoscopic lens was manually rubbed with clean gauze by a scrub nurse.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438890


Contacts
Contact: Taejong Song, MD PhD 82-2-2001-2582 taejong.song@gmail.com
Contact: Donghee Lee, MD 82-2-2001-2582 jimmy125@naver.com

Locations
Korea, Republic of
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 110-746
Contact: Taejong Song, MD PhD    82-2-2001-2582    taejong.song@gmail.com   
Principal Investigator: Taejong Song, MD, PhD         
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea

Responsible Party: Taejong Song, Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03438890     History of Changes
Other Study ID Numbers: 2018-03-005
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Genital Diseases, Female
Pharmaceutical Solutions
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents