跳至主要内容
临床试验/NCT03438890
NCT03438890已完成不适用

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

Kangbuk Samsung Hospital2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
the severity of LLF during the first 3-min operation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Allocation information was hidden from the participants and outcome assessor.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Warm saline (Device)

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.

干预措施: anti-fog agent (Device)

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.

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).

干预措施: chlorhexidine (Device)

结局指标

主要结局

the severity of LLF during the first 3-min operation

时间窗: At the time of surgery

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

次要结局

  • total time to spend for lens cleaning(At the time of surgery)
  • the number of lens cleansing(At the time of surgery)
  • the severity of LLF occurred during the remaining operative time except the first 3-min(At the time of surgery)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taejong Song

Professor

Kangbuk Samsung Hospital

研究点 (2)

Loading locations...

相似试验