Sabahattin Anil Ari
Izmir, 35000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT05973045
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Izmir, 35000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Operative hysteroscopy will be performed at room temperature distention medium.
Operative hysteroscopy will be performed using a heated distention medium.
Time frame: 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.
Time frame: 1 minute
Post-operative blood Na value will be checked.
Contact information is provided by the study sponsor or research team.
Ege University
Other
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
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