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Completed

NCT Number: NCT05239871

Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

About this study

Ultrasonographic findings will be conventionally divided in:

  • concomitant DE nodules
  • indirect DE signs

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with suspected deep endometriosis undergoing surgical approach

Exclusion criteria

  • patients with a previous surgical diagnosis of endometriosis
  • pazients with radiological evidence of parametrial endometriosis
  • patients who could not undergo transvaginal and/or transabdominal ultrasound for any technical reason

Treatment and study plan

Ultrasound

Diagnostic Test

Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Primary outcomes

  1. Number of patients with a surgical diagnosis of parametrial endometriosis

    Time frame: At surgery

  2. Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement

    Time frame: 1 week before surgical approach

  3. Number of significant ultrasonographic indirect DE signs predicting surgical involvement

    Time frame: 1 week before surgical approach

Sponsors and collaborators

Lead sponsor

Simone Ferrero

Other

Registry information

Official study title

Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Nov 2, 2022

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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