Clinical trial NCT06584760: Research on the Impact of Chronic Pelvic Pain on Endometriosis
Official title: Research on the Impact of Chronic Pelvic Pain on Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pelvic Pain
Endometriosis
Keywords: Chronic pelvic pain
Endometriosis
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine

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.

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.

Primary outcomes:
measure: Chronic pelvic pain
timeFrame: Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)
measure: In vitro detection results
timeFrame: Venous blood within 3 days before surgery; Endometriosis sample excised during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue
state: Zhejiang
Study officials:
affiliation: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Jiannan He
role: STUDY_CHAIR
References: