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NCT Number: NCT05973045

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sabahattin Anil Ari

Izmir, 35000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sabahattin Anil Ari, Asst. Prof.

CONTACT

[email protected]

+905547139994

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative Hysteroscopy 24 Centigrade Degree

Procedure

Operative hysteroscopy will be performed at room temperature distention medium.

Operative Hysteroscopy 37 Centigrade Degree

Procedure

Operative hysteroscopy will be performed using a heated distention medium.

Primary outcomes

  1. Post-operative pain

    Time frame: 3 hours

    Post 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 outcomes

  1. Post operavite Na Value Change

    Time frame: 1 minute

    Post-operative blood Na value will be checked.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabahattin A Ari, Asst. Prof.

CONTACT

[email protected]

+905547139994

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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