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

NCT ID: NCT04296760

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-11-01

Brief Summary

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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).

Detailed Description

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Conditions

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Endometriosis, Rectum Endometriosis of Vagina Endometriosis Rectovaginal Septum Endometriosis Pelvic Endometriosis of Colon Endometriosis

Keywords

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rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with suspicious of deep posterior pelvic endometriosis

Rectal water-contrast transvaginal ultrasonography

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum

Sonovaginography

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina

Interventions

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Rectal water-contrast transvaginal ultrasonography

Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum

Intervention Type DIAGNOSTIC_TEST

Sonovaginography

Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fabio Barra

OTHER

Sponsor Role lead

Responsible Party

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Fabio Barra

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fabio Barra, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Policlinico San Martino

Locations

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Ospedale Policlinico San Martino

Genoa, , Italy

Site Status

Countries

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Italy

References

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Leone Roberti Maggiore U, Biscaldi E, Vellone VG, Venturini PL, Ferrero S. Magnetic resonance enema vs rectal water-contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):524-532. doi: 10.1002/uog.15934.

Reference Type BACKGROUND
PMID: 27060846 (View on PubMed)

Ferrero S, Biscaldi E, Vellone VG, Venturini PL, Leone Roberti Maggiore U. Computed tomographic colonography vs rectal water- contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis: a pilot study. Ultrasound Obstet Gynecol. 2017 Apr;49(4):515-523. doi: 10.1002/uog.15905.

Reference Type BACKGROUND
PMID: 26935873 (View on PubMed)

Other Identifiers

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ENHANCED-ETV-ENDO

Identifier Type: -

Identifier Source: org_study_id