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

• Sponsor: Ospedale Policlinico San Martino (Other)
• Overall Status: Completed
• CT.gov ID: NCT04295343
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Actual Duration (Months): 35.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis, Sigmoid; Endometriosis, Rectum	Diagnostic Test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography; Diagnostic Test: Computed colonography

Study Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of rectosigmoid endometriosis. [At maximum 6 months before laparoscopic surgical approach]

   The results of imaging will be compared with surgical and histological findings.

Secondary Outcome Measures

1. 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]

   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. [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 [At maximum 6 months before laparoscopic surgical approach]

   The results of imaging will be compared with surgical and histological findings.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Policlinico San Martino	Genova		Italy

Sponsors and Collaborators

• Ospedale Policlinico San Martino

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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. Review. English, Italian.

• Responsible Party: Fabio Barra, Principal Investigator, Ospedale Policlinico San Martino
• ClinicalTrials.gov Identifier: NCT04295343
• Other Study ID Numbers: 3dETV-CTC-ENDO
• First Posted: Mar 4, 2020
• Last Update Posted: Jun 1, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fabio Barra, Principal Investigator, Ospedale Policlinico San Martino: Rectosigmoid endometriosis
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Jun 1, 2020