Clinical trial NCT04399668: Comparison of Ultrasound-determined and Intraoperative #Enzian-classification in Patients With Deep Endometriosis
Official title: Comparison of a Preoperative Ultrasound-determined and the Intraoperative #Enzian-classification in Patients With Deep Endometriosis (DE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Deep endometriosis (DE)
Transvaginal sonography (TVS)
Enzian classification
#Enzian classification
Lead sponsor: Woman and Health Private Clinic Vienna
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 745
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who are scheduled for a radical surgical treatment of deep endometriosis (DE), undergo preoperative evaluation by transvaginal sonography (TVS) and don't fall under the exclusion criteria will be included in this study.

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentages of concordances between preoperative TVS defined #Enzian with the intraoperatively determined #Enzian classification in each #Enzian compartment
timeFrame: 1 to 7 days
Secondary outcomes:
measure: Sensitivity and specificity for the detection of endometriotic lesions by preoperative TVS examination using #Enzian
timeFrame: 1 to 7 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: St. John of God Hospital Vienna
Study officials:
affiliation: Woman & Health Private Clinic Vienna
name: Gernot Hudelist, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: