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

Endometriosis, Rectum Clinical Trial

— 3Dvs2D-RWC-TVS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04339946
• Other study ID #: 3Dvs2D-RWC-TVS
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2021
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2021
• 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 of Colon
• Endometriosis, Rectum

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 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	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
Secondary	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
Secondary	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
Secondary	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