Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06720688

Enrollment

300

Registered

2024-12-06

Start date

2024-03-23

Completion date

2024-10-11

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Rectum

Keywords

Endometriosis, Ultrasound, Gynaecology

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results