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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04339946

Acronym

3Dvs2D-RWC-TVS

Enrollment

240

Registered

2020-04-09

Start date

2018-01-01

Completion date

2022-03-01

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis of Colon, Endometriosis, Rectum

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.

Interventions

DIAGNOSTIC_TESTThree-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.

DIAGNOSTIC_TESTTwo-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026