Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis

NCT ID: NCT04406155

Last Updated: 2020-07-27

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-01-01

Brief Summary

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Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.

Detailed Description

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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. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.

Conditions

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Endometriosis, Rectum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with suspicion of rectosigmoid endometriosis

3D-RWC-TVS with bowel preparation

Intervention Type PROCEDURE

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.

Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.

3D-RWC-TVS without bowel preparation

Intervention Type PROCEDURE

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.

Interventions

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3D-RWC-TVS with bowel preparation

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.

Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.

Intervention Type PROCEDURE

3D-RWC-TVS without bowel preparation

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 PROCEDURE

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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Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

OTHER

Sponsor Role lead

Responsible Party

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Simone Ferrero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Ferrero, MD, PhD

Role: STUDY_DIRECTOR

IRRCS Ospedale Policlinico San Martino

Locations

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IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Countries

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Italy

References

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Ferrero S, Barra F, Stabilini C, Vellone VG, Leone Roberti Maggiore U, Scala C. Does Bowel Preparation Improve the Performance of Rectal Water Contrast Transvaginal Ultrasonography in Diagnosing Rectosigmoid Endometriosis? J Ultrasound Med. 2019 Apr;38(4):1017-1025. doi: 10.1002/jum.14790. Epub 2018 Sep 24.

Reference Type BACKGROUND
PMID: 30246880 (View on PubMed)

Ferrero S, Scala C, Stabilini C, Vellone VG, Barra F, Leone Roberti Maggiore U. Transvaginal sonography with vs without bowel preparation in diagnosis of rectosigmoid endometriosis: prospective study. Ultrasound Obstet Gynecol. 2019 Mar;53(3):402-409. doi: 10.1002/uog.19194. Epub 2019 Feb 6.

Reference Type BACKGROUND
PMID: 30079504 (View on PubMed)

Other Identifiers

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BP-3DRWC-TVS-RECTOSIG

Identifier Type: -

Identifier Source: org_study_id

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