Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis

Study Overview
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Brief Summary
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As the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. The aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (RWC-TVS), and sonovaginography (SVG) in patients with clinical suspicion of posterior deep endometriosis (DIE).

Official Title
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Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis

Conditions
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Endometriosis, Rectum, Endometriosis of Vagina, Endometriosis Rectovaginal Septum, Endometriosis Pelvic, Endometriosis of Colon, Endometriosis

Intervention / Treatment
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* Diagnostic Test: Rectal water-contrast transvaginal ultrasonography
* Diagnostic Test: Sonovaginography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis Exclusion Criteria: previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography) previous surgical diagnosis of posterior deep infiltrating endometriosis

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 |
| --- | --- |
| Women with suspicious of deep posterior pelvic endometriosis<br> | Diagnostic Test: Rectal water-contrast transvaginal ultrasonography<br>* Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum<br>Diagnostic Test: Sonovaginography<br>* Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina |  | At maximum 6 months before undergoing laparoscopic surgical approach | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis |  | At maximum 6 months before undergoing laparoscopic surgical approach | 
| Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge |  | At maximum 6 months before undergoing laparoscopic surgical approach | 
| Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis |  | At maximum 6 months before undergoing laparoscopic surgical approach | 
| Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina |  | At maximum 6 months before undergoing laparoscopic surgical approach | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis