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临床试验/NCT06584760
NCT06584760尚未招募不适用

Research on the Impact of Chronic Pelvic Pain on Endometriosis

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Chronic pelvic pain

研究概览

简要总结

Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.

Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.

详细描述

Conduct preoperative and postoperative endometriosis related questionnaire surveys on patients, such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Follow up will be conducted 1-2 months after surgery. Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected for in vitro testing using immunohistochemistry, ELISA, transcriptome sequencing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 to 50 years old;
  • Endometriosis diagnosed through previous surgery (confirmed solely by visual or histopathological examination), endometriosis discovered through imaging examination, deep infiltrating nodules discovered through palpation or imaging examination, and clinically suspected endometriosis;
  • No history of migraine or tension headaches;
  • No history of mental illness (such as restless leg syndrome, chronic fatigue syndrome, fibromyalgia, anxiety or panic attacks, depression).

排除标准

  • Postmenopausal state (spontaneous or surgical);
  • Previous hysterectomy and/or bilateral salpingo oophorectomy (prior to preoperative visit);
  • The patient or authorizer refuses.

结局指标

主要结局

Chronic pelvic pain

时间窗: Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)

Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring

In vitro detection results

时间窗: Venous blood within 3 days before surgery; Endometriosis sample excised during surgery

The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis

次要结局

未报告次要终点

研究者

发起方
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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