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

• Conditions: Endometriosis, Rectum; Endometriosis of Colon
• Interventions: Diagnostic Test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS); Diagnostic Test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

• Registration Number: NCT04339946
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-09
• Primary Completion: 2021-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-27
• Last Update Posted: 2021-03-30
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspicious of rectosigmoid endometriosis	Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)	-
Patients with suspicious of rectosigmoid endometriosis	Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)	-

Primary Outcome Measures

Name	Time	Method
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS 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

Name	Time	Method
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS 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.
To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS 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.
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	At maximum 6 months before laparoscopic surgical approach	The results of imaging will be compared with surgical and histological findings.
To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating rectosigmoid lumen stenosis due to endometriotic nodule	At maximum 6 months before laparoscopic surgical approach	The results of imaging will be compared with surgical and histological findings.

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy