Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis

Study Overview
=================
Brief Summary
-----------------
Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.

Detailed Description
-----------------
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. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.

Official Title
-----------------
Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis

Conditions
-----------------
Endometriosis, Rectum

Intervention / Treatment
-----------------
* Procedure: 3D-RWC-TVS with bowel preparation
* Procedure: 3D-RWC-TVS without bowel preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspicion of rectosigmoid endometriosis<br> | Procedure: 3D-RWC-TVS with bowel preparation<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. Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.<br>Procedure: 3D-RWC-TVS without bowel preparation<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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the accuracy of 3D-RWC-TVS with and without bowel preparation 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 with and without bowel preparation 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 with and without bowel preparation 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectosigmoid endometriosis, bowel preparation