Comparison of Ultrasound-determined and Intraoperative #E... | NCT04399668

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

NCT04399668

Sponsor

Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.

Status

Completed

Last Update Posted

Sep 14, 2021Actual

Enrollment

745Actual

Phase

Not provided

Conditions

Endometriosis

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

May 31, 2021Actual

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 18, 2020

First Posted Date

May 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2021

Last Update Posted Date

Sep 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc., MD, MSc Clinical Lecturer, Woman and Health Private Clinic ViennaSponsor-Investigator

Lead Sponsor

Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

745Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gernot Hudelist, MD, MSc	Woman & Health Private Clinic Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. John of God Hospital Vienna		Vienna		1020	Austria

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided