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临床试验/NCT05973045
NCT05973045招募中不适用

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

Ege University2 个研究点 分布在 2 个国家目标入组 244 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
244
试验地点
2
主要终点
Post-operative pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • Active vaginal, and cervical infection

研究组 & 干预措施

24 Centigrade Degree

Active Comparator

Operative hysteroscopy will be performed at room temperature distention medium.

干预措施: Operative Hysteroscopy 24 Centigrade Degree (Procedure)

37 Centigrade Degree

Active Comparator

Operative hysteroscopy will be performed using a heated distention medium.

干预措施: Operative Hysteroscopy 37 Centigrade Degree (Procedure)

结局指标

主要结局

Post-operative pain

时间窗: 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.

次要结局

  • Post operavite Na Value Change(1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabahattin Anıl Arı

Asst. Prof.

Izmir Bakircay University

研究点 (2)

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