Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis.
Time Frame: At maximum 6 months before laparoscopic surgical approach
The results of imaging will be compared with surgical and histological findings.
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
Investigators
Fabio Barra
Principal investigator
Ospedale Policlinico San Martino