Skip to main content
OpenTrials
Completed

NCT Number: NCT04296760

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Ospedale Policlinico San Martino

Genoa, 1632, Italy

Who can participate

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

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

Treatment and study plan

Rectal water-contrast transvaginal ultrasonography

Diagnostic Test

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

Sonovaginography

Diagnostic Test

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

Primary outcomes

  1. Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina

    Time frame: At maximum 6 months before undergoing laparoscopic surgical approach

Secondary outcomes

  1. Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis

    Time frame: At maximum 6 months before undergoing laparoscopic surgical approach

  2. Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge

    Time frame: At maximum 6 months before undergoing laparoscopic surgical approach

  3. Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis

    Time frame: At maximum 6 months before undergoing laparoscopic surgical approach

  4. Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina

    Time frame: At maximum 6 months before undergoing laparoscopic surgical approach

Sponsors and collaborators

Lead sponsor

Fabio Barra

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Nov 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.