Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis

November 16, 2020 updated by: Fabio Barra
As the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. The aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (RWC-TVS), and sonovaginography (SVG) in patients with clinical suspicion of posterior deep endometriosis (DIE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 1632
        • Ospedale Policlinico San Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes

Description

Inclusion Criteria:

  • clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis

Exclusion Criteria:

  • previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
  • previous surgical diagnosis of posterior deep infiltrating endometriosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with suspicious of deep posterior pelvic endometriosis
Diagnostic test: Rectal water-contrast transvaginal ultrasonography
Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum
Diagnostic test: Sonovaginography
Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
Time Frame: At maximum 6 months before undergoing laparoscopic surgical approach
At maximum 6 months before undergoing laparoscopic surgical approach

Secondary Outcome Measures

Outcome Measure
Time Frame
Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis
Time Frame: At maximum 6 months before undergoing laparoscopic surgical approach
At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge
Time Frame: At maximum 6 months before undergoing laparoscopic surgical approach
At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis
Time Frame: At maximum 6 months before undergoing laparoscopic surgical approach
At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
Time Frame: At maximum 6 months before undergoing laparoscopic surgical approach
At maximum 6 months before undergoing laparoscopic surgical approach

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fabio Barra

Investigators

  • Principal Investigator: Fabio Barra, MD, Ospedale Policlinico San Martino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENHANCED-ETV-ENDO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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