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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis, Rectum, Endometriosis of Colon

Intervention / Treatment
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* Diagnostic Test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)
* Diagnostic Test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspicious of rectosigmoid endometriosis<br> | Diagnostic Test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)<br>* 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.<br>Diagnostic Test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)<br>* Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |