Research on the Impact of Chronic Pelvic Pain on Endometriosis

NCT ID: NCT06584760

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-09-30

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.

Conditions

Chronic Pelvic Pain; Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis group

Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiannan He

Role: STUDY_CHAIR

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Locations

The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue

Yiwu, Zhejiang, China

Countries

China

Central Contacts

Jiannan He

Role: CONTACT

8018038@zju.edu.cn

13615893226

Facility Contacts

Jiannan He

Role: primary

8018038@zju.edu.cn

+86 13615893226

Other Identifiers

KY-2024-152

Identifier Type: -

Identifier Source: org_study_id