An interventional study of Warm saline and anti-fog agent in Gynecologic Disease, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
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Among 20 studies in Genital Diseases, Female with a site in Korea, Republic of — none open to participants now, none under way, none of them phase 3. Genital Diseases, Female · Korea, Republic of.
Among the 20 studies in Genital Diseases, Female with a site in Korea, Republic of, this one is the 6th largest by enrollment, is one of 2 that started in 2018, is one of 14 with no phase, and was the 13th registered.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
Browse Genital Diseases, Female studies →None of the 20 studies in Genital Diseases, Female with a site in Korea, Republic of is open now. The open studies under Genital Diseases, Female, anywhere →
Of the 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Median enrollment 79 across the 20 interventional studies. Of the 13 that completed or were terminated, 1 (8%) have results posted.
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4 of 20 have an industry lead sponsor. The 10 most frequent:
Kangbuk Samsung Hospital is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Kangbuk Samsung Hospital has 5 studies filed under Genital Diseases, Female — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Genital Diseases, Female with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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 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.
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.
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.
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).
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).
Time frame: At the time of surgery
the severity of LLF occurred during the remaining operative time except the first 3-min
The severity of LLF was rated on a scale of 0 (the clearest) to 10 (the foggiest).
Time frame: At the time of surgery
the number of lens cleansing
We will assess the number of lens cleansing at the time of surgery.
Time frame: At the time of surgery
total time to spend for lens cleaning
We will assess the total time to spend for lens cleansing at the time of surgery.
Time frame: At the time of surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Oct 2018, 5 months.
Of 55 non-industry interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 5 months is below that.
Counting every sponsor, half of 65 studies reached it within 14 months; a quarter within 8 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Kangbuk Samsung Hospital