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

NCT04399668 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 745
• Locations: 1 country
• Sites: 1

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).

Conditions

Endometriosis

Keywords

Endometriosis; Deep endometriosis (DE); Transvaginal sonography (TVS); Enzian classification; #Enzian classification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and specificity for the detection of endometriotic lesions by preoperative TVS examination using #Enzian

  1 to 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.: lead

Study Sites (1)

St. John of God Hospital Vienna

Vienna, 1020, Austria

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Gernot Hudelist, MD, MSc

  Woman & Health Private Clinic Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc Clinical Lecturer

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

AU (1)