The Asymmetry Distribution of Endometriotic Lesions: Italian Multicenter Study

NCT07304245 | Completed

• 2 other identifiers: 0029787 UNICCHIENDO
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors

Outcome Measures

Primary Outcomes (1)

• Asymmetric distribution of endometriotic lesions on paired pelvic organs

  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.

  At the time of index surgery

Secondary Outcomes (1)

• Asymmetric distribution of malignant ovarian lesions related to endometriosis

  At the time of index surgery

Interventions

surgery PROCEDURE

All patients enrolled in the study underwent surgery for endometriosis between 2013 and 2023.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with histological diagnosis of endometriosis and endometriosis associated with endometrioid carcinoma, clear cell carcinoma and seromucinous borderline tumor operated at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and at the centers participating in the study from 01/2013 to 12/2023 will be recruited. Data relating to histological diagnosis will be collected from medical records. In particular, in addition to tumours associated with endometriosis, data will be collected from patients with a histological diagnosis of: 1. ovarian endometriosis 2. intestinal endometriosis 3. ureteral endometriosis 4. sciatic nerve endometriosis 5. inguinal-round ligament endometriosis 6. uterosacral ligament endometriosis 7. peritoneal endometriosis 8. diaphragmatic endometriosis 9. pleural and pulmonary endometriosis 10. umbilical endometriosis (associated with right hemidiaphragm and/or left hemidiaphragm)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Gynecology Unit, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: December 26, 2025
• Study Start: September 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-10

Locations

IT (1)