Skip to main content
OpenTrials
Completed

NCT Number: NCT04295343

Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis, Sigmoid Endometriosis Endometriosis, Rectum 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

Genova, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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

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.

Computed colonography

Diagnostic Test

Computed colonography or virtual colonoscopy uses special x-ray equipment to examine the large intestine. During the exam, a small tube is inserted a short distance into the rectum to allow for inflation with gas while computed tomographic images of the colon and the rectum are taken.

Primary outcomes

  1. To compare the accuracy of 3D-RWC-TVS and CTC 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 and CTC 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 and CTC 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.

  3. To compare the precision of 3D-RWC-TVS and CTC in estimating and the distance between the lower margin of the rectosigmoid endometriotic nodules and the anal verge

    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

Ospedale Policlinico San Martino

Other

Registry information

Official study title

Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 4, 2020
Registry last updated
Jun 1, 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.