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

NCT03438890 | Completed

• 1 other identifier: 2018-03-005
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  At the time of surgery

• the number of lens cleansing

  At the time of surgery

• total time to spend for lens cleaning

  At the time of surgery

Study Arms (4)

Warm saline group

EXPERIMENTAL

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

anti-fog agent group

EXPERIMENTAL

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

chlorhexidine group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

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.

Warm saline group

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.

anti-fog agent group

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).

chlorhexidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Allocation information was hidden from the participants and outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 20, 2018
• Study Start: April 23, 2018
• Primary Completion: October 11, 2018
• Study Completion: November 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)