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

NCT04295343 | Completed

• 1 other identifier: 3dETV-CTC-ENDO
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis, Sigmoid; Endometriosis, Rectum

Keywords

Rectosigmoid endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To compare the precision of 3D-RWC-TVS and CTC in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules

  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.

  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

  At maximum 6 months before laparoscopic surgical approach

Study Arms (1)

Patients with suspicious of rectosigmoid endometriosis

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

Interventions

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.

Patients with suspicious of rectosigmoid endometriosis

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.

Patients with suspicious of rectosigmoid endometriosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical presentation suspected for rectosigmoid endometriosis

You may qualify if:

• \- pain and intestinal symptoms suggestive of rectosigmoid endometriosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Ospedale Policlinico San Martino

Genova, Italy

Location

Related Publications (3)

• 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.

  PMID: 26935873 BACKGROUND

• 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.

  PMID: 20595942 BACKGROUND

• 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.

  PMID: 32344709 RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

Colonography, Computed Tomographic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Diagnostic Techniques, Digestive System

Study Officials

• Simone Ferrero, MD, PhD

  IRCCS Ospedale Policlinico San Martino

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: March 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: February 1, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

IT (1)