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Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy

Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05973045
Enrollment
244
Registered
2023-08-02
Start date
2023-09-01
Completion date
2026-09-30
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

hysteroscopy

Brief summary

Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. theTaim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.

Detailed description

Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. The optimum distention medium temperature has not been determined in the Best Practice in Outpatient Hysteroscopy Green Top Guideline organized by The Royal College of Obstetricians and Gynecologists and Guideline on Management of Fluid Distension Media in Operative Hysteroscopy organized by the European Society of Gynecological Endoscopy. In routine practice, some physicians use distention fluid at room temperature, while others use it by warming it at body temperature. It is known that colder fluids cause irregular contractions in the uterus. In prospective studies, the effects of heating distention media at body temperature on pain were reported inconsistently. As clear data could not be obtained, the risk of further intravasation and hyponatremia that may occur with the image quality and, more importantly, the heating of the fluid was ignored. But; Freitas Fonseca et al. In his in vitro study in Brazil, it was shown by theoretical calculations that heating hysteroscopy irrigation fluids from 270C to 370C increased intravasation by 53%. In light of the literature, and based on the ideas and possible risks in question, the aim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.

Interventions

PROCEDUREOperative Hysteroscopy 24 Centigrade Degree

Operative hysteroscopy will be performed at room temperature distention medium.

PROCEDUREOperative Hysteroscopy 37 Centigrade Degree

Operative hysteroscopy will be performed using a heated distention medium.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective Randomized Controlled Clinical Study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain3 hoursPost operative pain will evalute with numeric pain rating scale The scale is scored from 0 to 10. 0 means no pain and 10 means the most severe pain experienced.

Secondary

MeasureTime frameDescription
Post operavite Na Value Change1 minutePost-operative blood Na value will be checked.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSabahattin A Ari, Asst. Prof.
s.anil.ari.md@gmail.com+905547139994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026