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临床试验/NCT03852615
NCT03852615已完成不适用

The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Anti Mullarian Hormone (AMH) change

研究概览

简要总结

Ovarian torsion is a relatively common gynecological emergency, usually presenting as acute lower abdominal pain. Due to patient's presentation diversity, the diagnosis is clinical and requires integration of different factors and the exclusion of other non-gynecological pathologies. Surgery is the definitive treatment and may still be effective after several hours of symptoms. Delay in treatment can impact fertility adversely. The aim of this study is to evaluate the change in anti mullarian hormone before and after laparoscopic de-torsion of the ovary in our medical center compared to controls.

详细描述

Ovarian torsion is a relatively common gynecological emergency, usually presenting as acute lower abdominal pain. The underlying pathophysiology involves torsion of the ovarian tissue on its pedicle leading to reduced venous return, stromal edema, internal hemorrhage and infarction with the subsequent sequelae.

The diagnosis of ovarian torsion is not an easy diagnosis to make and it is commonly missed. Signs and symptoms often mimic other disorders such as appendicitis, pyelonephritis, and nephrolithiasis. Abnormal arterial blood flow on ultrasound does not rule out ovarian torsion and not every patient will have a mass on imaging or a palpable mass on examination. Patients may have symptoms for several hours or days, and thus, may present even with a longer duration of symptoms. Due to patient's presentation diversity, the diagnosis is clinical and requires integration of different factors and the exclusion of other non-gynecological pathologies.

Surgery is the definitive treatment and may still be effective after several hours of symptoms. Delay in treatment can impact fertility adversely. Conservative laparoscopic surgery for de-torsion is considered a safe procedure to preserve ovarian function in women with adnexal torsion and is mostly salvaged ovaries will maintain viability after de-torsion.

Although the main reason for emergent operation is to rescue ovarian tissue in order to preserve future fertility, studies are scarce and mostly performed on animals models. Yasa et al, studied the ovarian reserve evaluated by antral follicle count and AMH levels in 11 patients with ovarian torsion that underwent laparoscopic de-torsion rand found no significant change in serum AMH level at 1 and 3 months after laparoscopic de-torsion compared with the preoperative levels, however sample size was small. The aim of this study is to evaluate the change in anti mullarian hormone before and after laparoscopic de-torsion of the ovary in our medical center compared to controls.

Material and methods This is a prospective case control study including all women admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion, that are planned to go through laparoscopic surgery. Study group will include women that will be diagnosed with ovarian torsion during operation that will be compared to controls- women that ovarian torsion was not demonstrated.

研究设计

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

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Suspected ovarian torsion
  • Laparoscopy operation - explorative / de-torsion of ovary

排除标准

  • Severe endometriosis
  • Known premature ovarian failure
  • Past ovarian operations other than de- torsion

结局指标

主要结局

Anti Mullarian Hormone (AMH) change

时间窗: From date of recruitment before laparoscopy until three month after laparoscopy

The change in Anti Mullarian Hormone (AMH) levels before and three month after laparoscopy

次要结局

  • Ovarian change in color after de-torsion during laparoscopy(During laparoscopic operation, and through study completion, an average of 1 year)
  • Time to de-torsion(Estimated time from admission to the emergency room to de-torsion during laparoscopy in minutes)
  • Ovarian size after de-torsion during laparoscopy(During laparoscopic operation, and through study completion, an average of 1 year)

研究者

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

Dr. Aya Mohr-Sasson

Principal Investigator

Sheba Medical Center

研究点 (2)

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