Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID05973045

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

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

Loading map...

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

Similar Trials

A Randomized Controlled Trial Comparing the Cosmetic Outcome...

Wound Complication

Actively Recruiting

1 location

Intracanalicular Dexamethasone Insert for Postoperative Pain...

Vitreoretinal Surgery

Actively Recruiting

1 location

A Randomized, Placebo-Controlled Study to Evaluate the Effic...

Post-operative Pain

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here