Comparison of Ultrasound-determined and Intraoperative #Enzian-classification in Patients With Deep Endometriosis

Endometriosis Clinical Trial

Official title:

Comparison of a Preoperative Ultrasound-determined and the Intraoperative #Enzian-classification in Patients With Deep Endometriosis (DE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399668
• Other study ID #: 1
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Woman and Health Private Clinic Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Enzian classification, which was developed in order to describe deep endometriotic (DE) lesions, is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered as the first-line imaging technique for endometriosis. The aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination to the definitive intraoperative Enzian classification using the latest revision of the Enzian classification (#Enzian).

Description:

Endometriosis is a common disease with endometriotic lesions being found in the ovaries, peritoneum, or as deep endometriosis (DE) involving different pelvic organs and structures. In order to describe DE lesions, the Enzian classification was developed. In the last revision of this Enzian classification, the so-called #Enzian, presence and severity grades of ovarian and peritoneal endometriosis as well as adhesions involving tubes and ovaries are also described in addition to DE lesions.

The Enzian classification is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered to be the first-line imaging technique for this disease. Therefore, the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination (in the form of an US-#Enzian classification) to the definitive intraoperative Enzian classification (OP-#Enzian) using the latest revision of the Enzian classification (#Enzian).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 745
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All women who are scheduled for a radical surgical treatment of deep endometriosis (DE) and who undergo preoperative evaluation by transvaginal sonography (TVS)

Exclusion Criteria:

• Diagnosed or suspected malignancy

• Previous colorectal surgery or previous surgery for DE including full thickness bowel resection, vaginal resection or excision of a DE lesion involving the urinary bladder

• Virgo intacta women

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Austria	St. John of God Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of concordances between preoperative TVS defined #Enzian with the intraoperatively determined #Enzian classification in each #Enzian compartment	The percentages of concordantly described endometriotic lesions including the respective lesion sizes by the preoperative TVS defined #Enzian in each #Enzian compartment will be assessed, with the intraoperatively determined #Enzian classification taken as the reference, i.e. gold standard.	1 to 7 days
Secondary	Sensitivity and specificity for the detection of endometriotic lesions by preoperative TVS examination using #Enzian	Sensitivity and specificity for the detection of endometriotic lesions in different #Enzian compartments by the preoperative TVS examination (#Enzian) will be calculated.	1 to 7 days