3Dvs2D-RWC-TVS: Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with suspicious of rectosigmoid endometriosis
|
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.
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- pain and intestinal symptoms suggestive of rectosigmoid endometriosis
Exclusion Criteria:
-
previous surgical diagnosis of intestinal endometriosis
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previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema)
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history of colorectal surgery (except appendectomy)
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contraindications to bowel preparation or computed colonography (such as non-compliant patients and rectal malformations)
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previous bilateral ovariectomy
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psychiatric disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale Policlinico San Martino | Genoa | Italy | 16132 |
Sponsors and Collaborators
- Ospedale Policlinico San Martino
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 3Dvs2D-RWC-TVS