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Clinical Trials/NCT07304245
NCT07304245
Completed
Not Applicable

The Asymmetry of Endometriotic Lesions as Demonstration of the Theory of Menstrual Reflux and Anatomical Niches: Italian Multicenter Study by the ETIC Group

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 site in 1 country2,000 target enrollmentStarted: September 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
2,000
Locations
1
Primary Endpoint
Asymmetric distribution of endometriotic lesions on paired pelvic organs

Overview

Brief Summary

This study aims to understand whether endometriosis lesions - and tumors that can arise in association with endometriosis - occur more often on one side of the pelvis than the other.

During surgery, doctors will record the exact location of each lesion to see if there is a consistent right- or left-sided pattern.

Understanding these patterns may help improve knowledge about how endometriosis develops (pathogenesis), and thus improve its treatment.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age ≥18 years at the time of histological diagnosis of endometriosis
  • patients undergoing surgery with endometriotic lesions or patients with endometriotic lesions associated with endometrioid or clear cell ovarian cancer (Stage I-II) or borderline seromucinous ovarian cancer
  • first operation for endometriosis in the reference center (if recurrence consider only if both operations were performed at the reference center).

Exclusion Criteria

  • age \<18 years
  • patients affected by Stage I-II endometrioid or clear cell carcinoma or seromucinous borderline ovarian cancer not associated with endometriosis or in a more advanced stage of disease
  • women with an ultrasound diagnosis of endometriosis who have not undergone surgery
  • previous operations for endometriosis performed at another center

Outcomes

Primary Outcomes

Asymmetric distribution of endometriotic lesions on paired pelvic organs

Time Frame: At the time of index surgery

Proportion of patients presenting an asymmetric (right- or left-sided) distribution of endometriotic lesions on even and symmetrical pelvic organs (e.g., ovaries, uterosacral ligaments), based on the laterality observed and described during the index surgical procedure. Side-specific frequencies (right vs left) will be reported as number and percentage.

Secondary Outcomes

  • Asymmetric distribution of malignant ovarian lesions related to endometriosis(At the time of index surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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