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临床试验/NCT04830085
NCT04830085已完成不适用

Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis

Mersin University1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2017年2月10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
221
试验地点
1
主要终点
Presence of uterine tenderness during pelvic examination

研究概览

简要总结

Adenomyosis is a relatively common benign disorder in which endometrial gland and stroma are located within the myometrium resulting angiogenesis of the spiral vessel, hypertrophy of the surrounding smooth muscles and enlargement of the uterus. So far the definitive diagnosis still requires histologic analysis of the hysterectomy specimens or hysteroscopic or laparoscopic biopsy. There is no specific laboratory tests and reliable clinical standards for the diagnosis. The preoperative diagnosis of adenomyosis, would prevent unnecessary therapies, loss of time and use of resources in vain. Therefore precise prediction of this disease without surgery gains importance. Developing a scoring system with clinical evaluation for this purpose will be very helpful in solving this problem. From this point, the investigators aimed to develop a scoring system that will predict presence of adenomyosis wİth high sensitivity using clinical evaluation methods such as history, physical examination, ultrasonography and laboratory tests. A prospective cohort study was conducted with 221 patients. In the study, the investigators have created a clinical scoring system for this purpose for the first time in the literature. In this scoring system, there are simple parameters that can be easily used by the clinician, have a low cost and are repeatable. The effect of each parameter on predicting adenomyosis is different, and the total effect can be calculated according to the answer to be given to all questions. In this simple scoring system, parity, menarche, VAS scores of dysmenorrhea and dyspareunia, myometrial heterogeneity in ultrasonography and presence of tenderness during pelvic examination were found to be useful parameters in predicting the diagnosis of adenomyosis.

详细描述

A prospective cohort study was conducted in Mersin University Faculty of Medicine Department of Obstetrics and Gynecology between 10.02.2017 and 10.08.2017 with 221 patients who had undergone hysterectomy for benign disorders. The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies were visited before the operation and a detailed anamnesis was obtained. Physical and pelvic examinations with transvaginal ultrasound examinations were performed by the same investigator. Demographic characteristics, obstetric and gynecologic histories were noted. The amount of percieved pain was measured with Visual Analog Scale (VAS). Observing myometrial cysts, enlarged uterus, heterogeneous myometrium and or focal nodular areas during transvaginal sonography was considered to suggest adenomyosis. The hysterectomy specimes were evaluated by department of pathology. The diagnosis of adenomyosis was based on the presence of glandular extension ≥2.5 mm below the endometrial myometrial interface.

In order to develop a scoring system a regression analysis was carried out to find the parameters that were associated with the presence of adenomyosis. Number of parities, dyspareunia and dysmenorrhea VAS scores, age of menarche, presence of uterine tenderness and detection of heterogenous myometrium and myometrial cysts during ultrasonography were found to be the significant parameters.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies

排除标准

  • Patients with postoperative diagnosis of gynecologic malignancies and who were pregnants

结局指标

主要结局

Presence of uterine tenderness during pelvic examination

时间窗: 6 months

Severity of dysmenorrhea measured with Visual Analog Scale

时间窗: 6 months

Severity of dyspareunia measured with Visual Analog Scale

时间窗: 6 months

Detection of myometrial cysts during transvaginal ultrasonographic examination

时间窗: 6 months

Detection of myometrial heterogeneity during transvaginal ultrasonographic examination

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Hakan Aytan

Professor Dr.

Mersin University

研究点 (1)

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