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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973045
• Other study ID #: 617
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Ege University
• Contact: Sabahattin A Ari, Asst. Prof.
• Phone: +905547139994
• Email: s.anil.ari.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyponatremia
• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• Operative Hysteroscopy 24 Centigrade Degree
Operative hysteroscopy will be performed at room temperature distention medium.
• Operative Hysteroscopy 37 Centigrade Degree
Operative hysteroscopy will be performed using a heated distention medium.

Locations

Country	Name	City	State
Turkey	Sabahattin Anil Ari	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 hours
Secondary	Post operavite Na Value Change	Post-operative blood Na value will be checked.	1 minute