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Completed

NCT Number: NCT04406155

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

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.

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Key information

Conditions

Endometriosis, Rectum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genova, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-RWC-TVS with bowel preparation

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

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.

Primary outcomes

  1. To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis.

    Time frame: At maximum 6 months before laparoscopic surgical approach

    The results of imaging will be compared with surgical and histological findings.

Secondary outcomes

  1. To compare the precision of 3D-RWC-TVS with and without bowel preparation in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules

    Time frame: At maximum 6 months before laparoscopic surgical approach

    The results of imaging will be compared with surgical and histological findings.

  2. To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis.

    Time frame: At maximum 6 months before laparoscopic surgical approach

    The results of imaging will be compared with surgical and histological findings.

Sponsors and collaborators

Lead sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 28, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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