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

Endometriosis, Rectum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295343
• Other study ID #: 3dETV-CTC-ENDO
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2020
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Rectum
• Endometriosis, Sigmoid

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Policlinico San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Barra F, Biscaldi E, Scala C, Laganà 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 Rectosigmoi — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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