Clinical trial NCT05239871: Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis
Official title: Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Deep Endometriosis
Keywords: Parametrial endometriosis
Deep endometriosis
Transvaginal Ultrasound
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1078
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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).

Detailed description: Ultrasonographic findings will be conventionally divided in:

* concomitant DE nodules
* indirect DE signs

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with a surgical diagnosis of parametrial endometriosis
timeFrame: At surgery
measure: Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement
timeFrame: 1 week before surgical approach
measure: Number of significant ultrasonographic indirect DE signs predicting surgical involvement
timeFrame: 1 week before surgical approach
Secondary outcomes:
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria
state: VR
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.