Cohort Study of Endometriosis at Different Sites

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

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

Study Overview

• Status: Completed
• Conditions: Recruitment
• Intervention / Treatment: Procedure: Surgical endometrioma excision

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women aged between 18 years old to 50 years old, who were diagnosed as endometriosis (both pelvic and extra-pelvic) and received surgical treatment in PUMCH.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-recurrence group	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
Recurrence group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinicial outcome	recurrence or not	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Jinhua Leng, Pro., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: S-K1522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No