Ultrasound Features of Endometriosis of the Uterosacral Ligaments

NCT06787352 | Active Not Recruiting

• 1 other identifier: LUS2022
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 2

Brief Summary

Ultrasound features most indicative of endometriosis of the uterosacral ligaments, which connect the cervix to the sacrum and are part of the uterus support structures, and verify the actual presence of endometriosis of these ligaments during surgery

Conditions

Endometriosis

Keywords

endometriosis; gynaecology; surgery; uterus sacral ligaments

Outcome Measures

Primary Outcomes (1)

• Diagnostic ability of anteroposterior LUS thickness

  Comparison of the average thickness in millimetres of LUS with endometriosis and healthy LUS. The thickness cut-off of the LUS with highest diagnostic accuracy will be calculated by Receiver operating characteristic (ROC) curves

  During the first visit after enrollment

Secondary Outcomes (2)

• Learning curve of average experienced operators (Doctors in Specialised Training, MFS) in acquiring the optimal measurement of anteroposterior LUS thickness

  During the first visit after enrollment

• Evaluation of ultrasound parameters and differences between the two study groups

  During the first visit after enrollment

Study Arms (2)

Study group

Endometriosis patients with diseased LUS

Control group

Endometriosis patients with healthy LUS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for surgery for clinically and/or ultrasound-diagnosed endometriosis, referred to the presurgical outpatient clinic of the participating centres

You may qualify if:

• Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery;
• Age between 18 and 50 years;
• Signature of informed consent to the study

You may not qualify if:

• Post-menopausal women (spontaneous or iatrogenic);
• Virgo patients;
• Hysterectomised patients;
• Pregnant patients;
• Patients undergoing pelvic/vaginal radiotherapy;
• Previous LUS surgery;
• Clinical diagnosis of pelvic organ prolapse;
• Preoperative ultrasound more than 60 days prior to surgery;
• Failure at surgery and any subsequent histopathological examination to find pelvic endometriosis

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Siena, 53100, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 22, 2025
• Study Start: February 16, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-10

Locations

IT (2)