Effect of Fluid Temperature on Hysteroscopy Outcomes
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
This study tests whether using warmer or cooler fluid during hysteroscopy can improve image quality and reduce pain and risks for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir) |
| Trial ID | NCT05973045 on ClinicalTrials.gov |
What this trial studies
This study investigates how the temperature of the distention medium used during operative hysteroscopy affects image quality, the risk of hyponatremia, and post-operative pain. It compares the outcomes of using fluid at room temperature versus body temperature. The research aims to provide clearer guidelines on the optimal temperature for distention media to enhance patient comfort and safety during hysteroscopic procedures. By addressing inconsistencies in previous studies, this trial seeks to establish best practices in outpatient hysteroscopy.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for operative hysteroscopy due to endometrial polyps or small myomas, who have had at least one vaginal delivery and can communicate in Turkish or English.
Not a fit: Patients who are pregnant or have active vaginal or cervical infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and safety during hysteroscopic procedures for patients.
How similar studies have performed: While some studies have explored the effects of distention medium temperature, this specific investigation aims to clarify inconsistent findings, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To be planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma in the range of 2-3 cm * Having a vaginal delivery at least once before * Ability to communicate adequately in Turkish or English Exclusion Criteria: * Pregnancy * Active vaginal, and cervical infection
Where this trial is running
Izmir
- Sabahattin Anil Ari — Izmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Sabahattin A Ari, Asst. Prof. — Izmir Bakircay University
- Study coordinator: Sabahattin A Ari, Asst. Prof.
- Email: s.anil.ari.md@gmail.com
- Phone: +905547139994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.