Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity

NCT06720688 | Completed

• 1 other identifier: ENDOSIGNS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Association between the ultrasound appearance of deep bowel endometriosis and the frequency of pain

Conditions

Endometriosis Rectum

Keywords

Endometriosis; Ultrasound; Gynaecology

Outcome Measures

Primary Outcomes (1)

• Prevalence of moderate or severe clinical symptoms

  Prevalence of moderate or severe clinical symptoms in patients with newly diagnosed deep bowel endometriosis according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the IDEA Consensus.

  At diagnosis or in the previous 6 months

Secondary Outcomes (2)

• Ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions

  At diagnosis or in the previous 6 months

• Association between ultrasound morphology and specific clinical symptoms

  At diagnosis or in the previous 6 months

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

Patients with an ultrasound diagnosis of deep bowel endometriosis undergoing surgery and patients who are not candidates for surgery

You may qualify if:

• Patients aged ≥18 years;
• Presence of posterior rectus intestinal deep endometriosis confirmed on TV ultrasound between 01/01/2018 and 30/06/2023;
• Informed consent obtained

You may not qualify if:

• Virgo patients;
• Patients reporting intolerance to transvaginal ultrasound;
• Current or history of gynaecological oncology;
• Previous surgery of the sigma and rectum

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, 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 ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: March 23, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 11, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

IT (1)