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

Three-dimensional 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.

Study Overview

• Status: Completed
• Conditions: Endometriosis, Rectum; Endometriosis, Sigmoid
• Intervention / Treatment: Diagnostic test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography; Diagnostic test: Computed colonography

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy
    • Ospedale Policlinico San Martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical presentation suspected for rectosigmoid endometriosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with suspicious of rectosigmoid endometriosis

Diagnostic test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography; 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.; Diagnostic test: Computed colonography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of rectosigmoid endometriosis.	The results of imaging will be compared with surgical and histological findings.	At maximum 6 months before laparoscopic surgical approach

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the precision of 3D-RWC-TVS and CTC in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules	The results of imaging will be compared with surgical and histological findings.	At maximum 6 months before laparoscopic surgical approach
To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of multifocal rectosigmoid endometriosis.	The results of imaging will be compared with surgical and histological findings.	At maximum 6 months before laparoscopic surgical approach
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	The results of imaging will be compared with surgical and histological findings.	At maximum 6 months before laparoscopic surgical approach

Collaborators and Investigators

• Sponsor: Ospedale Policlinico San Martino
• Investigators: Study Director: Simone Ferrero, MD, PhD, IRCCS Ospedale Policlinico San Martino

Publications and helpful links

General Publications

• Ferrero S, Biscaldi E, Vellone VG, Venturini PL, Leone Roberti Maggiore U. Computed tomographic colonography vs rectal water- contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis: a pilot study. Ultrasound Obstet Gynecol. 2017 Apr;49(4):515-523. doi: 10.1002/uog.15905.
• Morotti M, Ferrero S, Bogliolo S, Venturini PL, Remorgida V, Valenzano Menada M. Transvaginal ultrasonography with water-contrast in the rectum in the diagnosis of bowel endometriosis. Minerva Ginecol. 2010 Jun;62(3):179-85. English, Italian.
• Barra F, Biscaldi E, Scala C, Lagana AS, Vellone VG, Stabilini C, Ghezzi F, Ferrero S. A Prospective Study Comparing Three-Dimensional Rectal Water Contrast Transvaginal Ultrasonography and Computed Tomographic Colonography in the Diagnosis of Rectosigmoid Endometriosis. Diagnostics (Basel). 2020 Apr 24;10(4):252. doi: 10.3390/diagnostics10040252.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Rectosigmoid endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 3dETV-CTC-ENDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No