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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain
• Intervention / Treatment: Procedure: Operative Hysteroscopy 24 Centigrade Degree; Procedure: Operative Hysteroscopy 37 Centigrade Degree

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 Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabahattin A Ari, Asst. Prof.; Phone Number: +905547139994; Email: s.anil.ari.md@gmail.com

Study Locations

• Turkey
  • Izmir, Turkey, 35000
    • Recruiting
    • Sabahattin Anil Ari
    • Contact: Sabahattin Anil Ari, Asst. Prof.; Phone Number: +905547139994; Email: s.anil.ari.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 24 Centigrade Degree; Operative hysteroscopy will be performed at room temperature distention medium.	Procedure: Operative Hysteroscopy 24 Centigrade Degree; Operative hysteroscopy will be performed at room temperature distention medium.
Active Comparator: 37 Centigrade Degree; Operative hysteroscopy will be performed using a heated distention medium.	Procedure: Operative Hysteroscopy 37 Centigrade Degree; Operative hysteroscopy will be performed using a heated distention medium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operavite Na Value Change	Post-operative blood Na value will be checked.	1 minute

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Sabahattin A Ari, Asst. Prof., Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hysteroscopy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Pain, Postoperative; Hyponatremia
• Other Study ID Numbers: 617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No