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Completed

NCT Number: NCT06720688

Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity

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

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Key information

Conditions

Endometriosis Rectum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of moderate or severe clinical symptoms

    Time frame: 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 outcomes

  1. Ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions

    Time frame: 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).

  2. Association between ultrasound morphology and specific clinical symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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