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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorEge University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Active vaginal, and cervical infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Operative Hysteroscopy 24 Centigrade Degree

    Procedure/Surgery

    Operative hysteroscopy will be performed at room temperature distention medium.

  • Operative Hysteroscopy 37 Centigrade Degree

    Procedure/Surgery

    Operative hysteroscopy will be performed using a heated distention medium.

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: 24 Centigrade DegreeActive comparator 1 intervention
Group B: 37 Centigrade DegreeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative pain

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.

Time frame
3 hours

Secondary outcomes

1

Post operavite Na Value Change

Post-operative blood Na value will be checked.

Time frame
1 minute

Other outcomes

Sponsors and contacts

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Ege University

Lead sponsor

Izmir Bakircay University

Sponsor institution