Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

Endometriosis Clinical Trial

Official title:

Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239871
• Other study ID #: ULTRA-PARAMETRENDO I
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2022
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Ultrasonographic findings will be conventionally divided in:

• concomitant DE nodules

• indirect DE signs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1078
• Est. completion date: September 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis

Intervention

Diagnostic Test:
• Ultrasound
Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

Locations

Country	Name	City	State
Italy	Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	VR

Sponsors (1)

Lead Sponsor	Collaborator
Simone Ferrero

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. 2 — View Citation

Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installé AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Gonçalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferr — View Citation

Guerriero S, Martinez L, Gomez I, Pascual MA, Ajossa S, Pagliuca M, Alcázar JL. Diagnostic accuracy of transvaginal sonography for detecting parametrial involvement in women with deep endometriosis: systematic review and meta-analysis. Ultrasound Obstet G — View 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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a surgical diagnosis of parametrial endometriosis		At surgery
Primary	Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement		1 week before surgical approach
Primary	Number of significant ultrasonographic indirect DE signs predicting surgical involvement		1 week before surgical approach