Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis

NCT ID: NCT04339946

Last Updated: 2021-03-30

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

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-03-01

Brief Summary

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An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis is of paramount importance for the clinicians in order to inform the patients on the potential surgical or medical treatments. It is well established that transvaginal ultrasonography is the first-line investigation in patients with suspicion of deep infiltrating endometriosis.

An improvement in the performance of transvaginal ultrasonography in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast during transvaginal ultrasonographic scan.

Detailed Description

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Conditions

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Endometriosis, Rectum Endometriosis of Colon

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with suspicious of rectosigmoid endometriosis

Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)

Intervention Type DIAGNOSTIC_TEST

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.

Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

Intervention Type DIAGNOSTIC_TEST

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

Interventions

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Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.

Intervention Type DIAGNOSTIC_TEST

Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* pain and intestinal symptoms suggestive of rectosigmoid endometriosis

Exclusion Criteria

* previous surgical diagnosis of intestinal endometriosis
* previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema)
* history of colorectal surgery (except appendectomy)
* contraindications to bowel preparation or computed colonography (such as non-compliant patients and rectal malformations)
* previous bilateral ovariectomy
* psychiatric disorders
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Policlinico San Martino

OTHER

Sponsor Role lead

Responsible Party

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Fabio Barra

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale Policlinico San Martino

Genoa, , Italy

Site Status

Countries

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Italy

References

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Morotti M, Ferrero S, Bogliolo S, Venturini PL, Remorgida V, Valenzano Menada M. Transvaginal ultrasonography with water-contrast in the rectum in the diagnosis of bowel endometriosis. Minerva Ginecol. 2010 Jun;62(3):179-85. English, Italian.

Reference Type BACKGROUND
PMID: 20595942 (View on PubMed)

Other Identifiers

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3Dvs2D-RWC-TVS

Identifier Type: -

Identifier Source: org_study_id

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