Clinical Trials Directory

Trials / Completed

CompletedNCT04406155

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

Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

Summary

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

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

Interventions

TypeNameDescription
PROCEDURE3D-RWC-TVS with bowel preparationRectal 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.
PROCEDURE3D-RWC-TVS without bowel preparationRectal 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.

Timeline

Start date
2018-01-01
Primary completion
2019-12-01
Completion
2020-01-01
First posted
2020-05-28
Last updated
2020-07-27

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04406155. Inclusion in this directory is not an endorsement.