Cohort Study of Endometriosis at Different Sites

Recruitment Clinical Trial

Official title:

Analysis of Clinical Characteristics and Risk Factors of Recurrence of Endometriosis at Different Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783623
• Other study ID #: S-K1522
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: March 2, 2021

Study information

• Verified date: March 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To present the clinical characteristics of pelvic or extra-pelvic endometriosis and explore the potential risk factors of pathogenesis and recurrence by comparing patients with endometriosis at different sites

Description:

Endometriosis is a chronic inflammatory disease defined as the presence of endometrial glands and stroma outside of the internal epithelial lining of the cavum uteri, affecting up to 10% of reproductive age women. It is rarely found in extrapelvic locations.This form of endometriosis may be difficult to diagnosis due to pleomorphic presentation. Despite complete excision with a safe margin and histopathological examination has been considered as definitive diagnosis and primary therapeutic treatment for extra-pelvic endometriosis, what is understood mainly comes from case reports and retrospective observations with limited number of cases. Moreover, approximately 6%-14% of patients with PEM who had underwent narrowly operative resection still suffered recurrent lesions, while risk factors were barely identified.

Patients with endometriosis at different sites in our hospital were collected for analysis of clinical characteristics namely demographic information, medical history, surgical records, pathological and imaging reports, serum levels of cancer antigen 125 (CA125), peri-operative medication. During long-term follow-up, prognosis of individuals could be identified by telephone or clinical interview. Based on data from medical records or clinical observation, risk model predicting recurrence will be established by comparing patients with different outcomes or exposed to different risk factors. Thus, management of endometriosis might be improved. Hopefully, pathogenesis of recurrent and primary endometriosis might be explained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients who were clinically diagnosed with endometriosis at different sites (pelvic and/or extra-pelvic) and received surgical treatment at PUMCH

Exclusion Criteria:

• i). underwent bilateral oophorectomy in the operation, ii). had incomplete records of inpatient management, iii). had no post-operative outpatient follow-up, iv). combined with malignancy.

Related Conditions & MeSH terms

• Endometriosis
• Recruitment

Intervention

Procedure:
• Surgical endometrioma excision
We collect medical records of patients who had underwent surgical endometrioma excision at different sites in our hospital and conduct telephone or clinical interview

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinicial outcome	recurrence or not	2 months
Secondary	clinical characteristics	Demographic information, medical history, surgical records, pathological and imaging reports (pelvic and/or trans-perineal and/or endorectal ultrasonography, computed tomography, magnetic resonance imaging), serum levels of cancer antigen 125 (CA125), perioperative medication	2 months