Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Study Overview
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Brief Summary
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Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.

Official Title
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Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Conditions
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Endometriosis, Sigmoid, Endometriosis, Rectum

Intervention / Treatment
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* Diagnostic Test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography
* Diagnostic Test: Computed colonography


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

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 (3D) rectal water contrast transvaginal ultrasonography<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: Computed colonography<br>* Computed colonography or virtual colonoscopy uses special x-ray equipment to examine the large intestine. During the exam, a small tube is inserted a short distance into the rectum to allow for inflation with gas while computed tomographic images of the colon and the rectum are taken.<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 CTC 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 CTC 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 CTC 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 CTC 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectosigmoid endometriosis