Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis (3Dvs2D-RWC-TVS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometriosis, Rectum; Endometriosis of Colon
• Intervention / Treatment: Diagnostic test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS); Diagnostic test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• 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?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with suspicious of rectosigmoid endometriosis

Diagnostic test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS); 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: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS); Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS 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 2D-RWC-TVS 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 2D-RWC-TVS 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 2D-RWC-TVS 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
To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating rectosigmoid lumen stenosis due to endometriotic nodule	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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 27, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 3Dvs2D-RWC-TVS

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