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

Not Applicable

Recruiting

• Conditions: Post-operative Pain
• Interventions: Procedure: Operative Hysteroscopy 37 Centigrade Degree; Procedure: Operative Hysteroscopy 24 Centigrade Degree

• Registration Number: NCT05973045
• Lead Sponsor: Ege University

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Study Start: 2023-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
37 Centigrade Degree	Operative Hysteroscopy 37 Centigrade Degree	Operative hysteroscopy will be performed using a heated distention medium.
24 Centigrade Degree	Operative Hysteroscopy 24 Centigrade Degree	Operative hysteroscopy will be performed at room temperature distention medium.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	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 Outcome Measures

Name	Time	Method
Post operavite Na Value Change	1 minute	Post-operative blood Na value will be checked.

Trial Locations

Locations (1)

Sabahattin Anil Ari; 🇹🇷 Izmir, Turkey