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Clinical Trials/NCT06584760
NCT06584760
Not Yet Recruiting
N/A

Research on the Impact of Chronic Pelvic Pain on Endometriosis

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 site in 1 country60 target enrollmentSeptember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pelvic Pain
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Enrollment
60
Locations
1
Primary Endpoint
Chronic pelvic pain
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
September 2027
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Chronic pelvic pain

Time Frame: 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

Time Frame: 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

Study Sites (1)

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