Actively Recruiting
Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
Led by Ege University · Updated on 2025-08-14
244
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Minimally invasive methods are preferred in gynecology for their benefits like less pain, shorter hospital stays, and better cosmetic outcomes. This research focuses on operative hysteroscopy, a small-scale surgical procedure inside the uterus. The study aims to understand how warming the distention fluid to body temperature affects image quality, the risk of low sodium levels (hyponatremia), and pain after surgery since current guidelines do not specify the best fluid temperature. The trial compares two groups: one undergoing operative hysteroscopy with room temperature fluid (24°C) and the other with warmed fluid at body temperature (37°C). Both groups receive the same surgical procedure, but the study investigates how the temperature of the fluid used to expand the uterus might impact outcomes. This study is randomized, and no blinding is used. Participants will have operative hysteroscopy planned for specific uterine conditions like endometrial polyps or small myomas. Researchers will monitor post-operative pain three hours after surgery and changes in sodium levels one minute after the procedure. The study involves women aged 18 to 65 who have had at least one vaginal delivery and can communicate in Turkish or English. Safety is assessed by excluding pregnant women and those with infections. The total participation timeline aligns with the surgery and immediate follow-up assessments.
CONDITIONS
Brief Title
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma sized 2-3 cm
- At least one prior vaginal delivery
- Able to communicate adequately in Turkish or English
- Female aged 18 to 65 years
You will not qualify if you...
- Pregnancy
- Active vaginal or cervical infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo operative hysteroscopy using either room temperature or heated distention medium to evaluate effects on pain, image quality, and hyponatremia risk.
1 treatment visit (in-person)
Duration - Up to 3 hours post-procedure
Participants are monitored for post-operative pain and changes in sodium levels after the procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Sabahattin Anil Ari
Izmir, Turkey (Türkiye), 35000
Actively Recruiting
Research Team
S
Sabahattin A Ari, Asst. Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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