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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04296760
Enrollment
250
Registered
2020-03-05
Start date
2018-01-01
Completion date
2020-11-01
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis

Brief summary

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).

Interventions

DIAGNOSTIC_TESTRectal water-contrast transvaginal ultrasonography

Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum

DIAGNOSTIC_TESTSonovaginography

Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina

Sponsors

Fabio Barra
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vaginaAt maximum 6 months before undergoing laparoscopic surgical approach

Secondary

MeasureTime frame
Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosisAt maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal vergeAt maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosisAt 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 vaginaAt maximum 6 months before undergoing laparoscopic surgical approach

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026