Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

NCT05239871 | Completed

• 1 other identifier: ULTRA-PARAMETRENDO I
• Study Type: observational
• Target: 1,078
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Endometriosis; Deep Endometriosis

Keywords

Parametrial endometriosis; Deep endometriosis; Transvaginal Ultrasound

Outcome Measures

Primary Outcomes (3)

• Number of patients with a surgical diagnosis of parametrial endometriosis

  At surgery

• Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement

  1 week before surgical approach

• Number of significant ultrasonographic indirect DE signs predicting surgical involvement

  1 week before surgical approach

Study Arms (2)

Women with surgical diagnosis of parametrial endometriosis

This cohort will include patients with surgical diagnosis of parametrial endometriosis

Diagnostic Test: Ultrasound

Women without surgical diagnosis of parametrial endometriosis

This cohort will include patients without surgical diagnosis of parametrial endometriosis

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Women with surgical diagnosis of parametrial endometriosis; Women without surgical diagnosis of parametrial endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected deep endometriosis undergoing surgical approach in a third-level referral center for endometriosis between January 2021 and December 2021

You may qualify if:

• patients with suspected deep endometriosis undergoing surgical approach

You may not qualify if:

• 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

Sponsors & Collaborators

• Simone Ferrero: lead

Study Sites (1)

Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

Location

Related Publications (5)

• Guerriero S, Martinez L, Gomez I, Pascual MA, Ajossa S, Pagliuca M, Alcazar JL. Diagnostic accuracy of transvaginal sonography for detecting parametrial involvement in women with deep endometriosis: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2021 Nov;58(5):669-676. doi: 10.1002/uog.23754.

  PMID: 34358386 RESULT

• Mabrouk M, Raimondo D, Arena A, Iodice R, Altieri M, Sutherland N, Salucci P, Moro E, Seracchioli R. Parametrial Endometriosis: The Occult Condition that Makes the Hard Harder. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):871-876. doi: 10.1016/j.jmig.2018.08.022. Epub 2018 Aug 31.

  PMID: 30176361 RESULT

• Ceccaroni M, Clarizia R, Roviglione G. Nerve-sparing Surgery for Deep Infiltrating Endometriosis: Laparoscopic Eradication of Deep Infiltrating Endometriosis with Rectal and Parametrial Resection According to the Negrar Method. J Minim Invasive Gynecol. 2020 Feb;27(2):263-264. doi: 10.1016/j.jmig.2019.09.002. Epub 2019 Sep 10.

  PMID: 31518711 RESULT

• Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installe AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Goncalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferrero S, Leon M, Bignardi T, Holland T, Jurkovic D, Benacerraf B, Osuga Y, Somigliana E, Timmerman D. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955. Epub 2016 Jun 28.

  PMID: 27349699 RESULT

• Barra F, Zorzi C, Albanese M, Stepniewska A, Deromemaj X, De Mitri P, Roviglione G, Clarizia R, Gustavino C, Ferrero S, Ceccaroni M. Ultrasonographic Findings Indirectly Predicting Parametrial Involvement in Patients with Deep Endometriosis: The ULTRA-PARAMETRENDO I Study. J Minim Invasive Gynecol. 2023 Jan;30(1):61-72. doi: 10.1016/j.jmig.2022.10.008. Epub 2022 Oct 29.

  PMID: 36591808 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: January 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

IT (1)