Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

NCT ID: NCT05239871

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1078 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-01

Brief Summary

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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).

Detailed Description

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Ultrasonographic findings will be conventionally divided in:

* concomitant DE nodules
* indirect DE signs

Conditions

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Endometriosis Deep Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women with surgical diagnosis of parametrial endometriosis

This cohort will include patients with surgical diagnosis of parametrial endometriosis

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Women without surgical diagnosis of parametrial endometriosis

This cohort will include patients without surgical diagnosis of parametrial endometriosis

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Interventions

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Ultrasound

Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Simone Ferrero

OTHER

Sponsor Role lead

Responsible Party

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Simone Ferrero

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, VR, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 34358386 (View on PubMed)

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.

Reference Type RESULT
PMID: 30176361 (View on PubMed)

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.

Reference Type RESULT
PMID: 31518711 (View on PubMed)

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.

Reference Type RESULT
PMID: 27349699 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36591808 (View on PubMed)

Other Identifiers

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ULTRA-PARAMETRENDO I

Identifier Type: -

Identifier Source: org_study_id

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