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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Controlled Clinical Study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24 Centigrade Degree

Operative hysteroscopy will be performed at room temperature distention medium.

Group Type ACTIVE_COMPARATOR

Operative Hysteroscopy 24 Centigrade Degree

Intervention Type PROCEDURE

Operative hysteroscopy will be performed at room temperature distention medium.

37 Centigrade Degree

Operative hysteroscopy will be performed using a heated distention medium.

Group Type ACTIVE_COMPARATOR

Operative Hysteroscopy 37 Centigrade Degree

Intervention Type PROCEDURE

Operative hysteroscopy will be performed using a heated distention medium.

Interventions

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Operative Hysteroscopy 24 Centigrade Degree

Operative hysteroscopy will be performed at room temperature distention medium.

Intervention Type PROCEDURE

Operative Hysteroscopy 37 Centigrade Degree

Operative hysteroscopy will be performed using a heated distention medium.

Intervention Type PROCEDURE

Eligibility Criteria

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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