NCT04783623

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Recruitment

Outcome Measures

Primary Outcomes (1)

  • clinicial outcome

    recurrence or not

    2 months

Secondary Outcomes (1)

  • clinical characteristics

    2 months

Study Arms (2)

Non-recurrence group

Procedure: Surgical endometrioma excision

Recurrence group

Procedure: Surgical endometrioma excision

Interventions

Surgical endometrioma excisionPROCEDURE

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

Non-recurrence groupRecurrence group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

  • Jinhua Leng, Pro.

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

January 20, 2021

Primary Completion

March 2, 2021

Study Completion

March 2, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)