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临床试验/NCT04493983
NCT04493983已完成不适用

Evaluation of Oxidative Stress-related Biomarkers With a Histopathological and Biochemical Approach in Ovarian Tissue From a Human Carbondioxide Pneumoperitoneum-applied Ischemia/Reperfusion Model

Ismet Hortu2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology

研究概览

简要总结

Because of cellular changes in response to ischemia and a following period of reperfusion, damages to organs and different tissues occur. There are several ongoing studies to enlighten the pathophysiological processes underlying these damages inflicted by ischemia/reperfusion.

Gases (CO2) with low water content are used in pneumoperitoneum, which is a procedure to inflate the abdominal cavity with an appropriate gas for laparoscopic operations. In the current literature, it was shown that due to a restricted blood flow during the gas insufflation, ischemia develops and with the reperfusion of the organ in deflation period, oxidative stress and inflammation increases, leading to ischemia/reperfusion-related organ and tissue damages.

In the proposed study, biomarkers for ischemia/reperfusion-inflicted damage will be evaluated in a biochemical and histopathological perspective in biopsy samples of ovaries from a young patient group in which hysterectomy and bilateral salpingo-oophorectomy will be performed, laparoscopically.

详细描述

In the laparoscopic salpingo-oophorectomy, after the induction of anesthesia, an umbilical skin incision was performed. Pneumoperitoneum was established using dry, nonheated CO2 insufflation through a Veress needle. A 10-mm trocar was inserted into the abdominal cavity through the umbilical incision for the laparoscope. Subsequently, three 5-mm ancillary trocars, 2 on the lower abdominal quadrants and 1 on the left upper quadrant, were introduced to the abdominal space under direct optic visualization. IAP was set at 14 mm Hg and maintained with a gas insufflator (Endoflator; Karl Storz Endoscopy, Tuttlingen, Germany)Immediately after the port placement, unilateral oophorectomy was performed, and ovarian biopsies were obtained. The operation continued with ligation and transection of the contralateral utero-ovarian ligament and the bilateral round ligaments. The contralateral infundibulopelvic ligament, which contains the main vascular supply for the contralateral ovary, remained intact. Subsequently, anterior and posterior leaflets of the broad ligament were identified and dissected, and the bladder was placed away from the lower uterine segment. The uterus removed from vaginal way after necessary steps. After desufflation, the cuff closure procedure was performed vaginally. At the end of the closure, pneumoperitoneum was reestablished, the remaining contralateral ovary was removed immediately, and biopsies were obtained for histologic analyses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Transgender Men who wants to remove their uterus and both ovaries.

排除标准

  • Known endometriosis
  • Hysterectomized patient
  • Unacceptance to involve to the trial
  • Suspicion of malignancy

结局指标

主要结局

Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology

时间窗: 1-day (at the time of the surgery)

Histopathological investigation of ovaries after CO2 pneumoperitoneum -induced I/R

次要结局

未报告次要终点

研究者

发起方
Ismet Hortu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ismet Hortu

Clinical researcher, Ismet Hortu, MD., PhD. Department of Obstetrics and Gynecology, Ege University School of Medicine, Izmir, Turkey

Ege University

研究点 (2)

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