Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity

Completed

• Conditions: Endometriosis Rectum

• Registration Number: NCT06720688
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

Detailed Description

In order to improve the diagnostic power of the ultrasound method, it is important to evaluate the association between the ultrasound appearance of the nodule of intestinal deep endometriosis and the frequency of pain, thus assessing the prevalence of moderate or severe clinical symptoms, in patients with newly diagnosed intestinal deep endometriosis, according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the International Deep Endometriosis Analysis Group (IDEA) Consesus.

Study Timeline

• Study Start: 2024-03-23
• Primary Completion: 2024-08-30
• Status Verified: 2024-10
• Study Completion: 2024-10-11
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of moderate or severe clinical symptoms	At diagnosis or in the previous 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions	At diagnosis or in the previous 6 months	Calculate the proportion of ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions (adenomyosis, anterior endometriosis, parametrial, LUS).
Association between ultrasound morphology and specific clinical symptoms	At diagnosis or in the previous 6 months	Check whether the different categories of ultrasound morphology, described in the IDEA Consensus, are associated with specific clinical symptoms

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy