Cohort Study of Endometriosis at Different Sites

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04783623
Collaborator
(none)
146
1
1.3
108.4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
146 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Analysis of Clinical Characteristics and Risk Factors of Recurrence of Endometriosis at Different Sites
Actual Study Start Date :
Jan 20, 2021
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Mar 2, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. clinicial outcome [2 months]

    recurrence or not

Secondary Outcome Measures

  1. clinical characteristics [2 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
XiaoyanLi, Primary investigator, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04783623
Other Study ID Numbers:
  • S-K1522
First Posted:
Mar 5, 2021
Last Update Posted:
Mar 5, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2021