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NCT04296760 Clinical Trial

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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04296760
Other study ID # ENHANCED-ETV-ENDO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date November 1, 2020

Study information
Verified date November 2020
Source Ospedale Policlinico San Martino
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date November 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Rectal water-contrast transvaginal ultrasonography
Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum
• Sonovaginography
Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina

Locations
Country Name City State
Italy Ospedale Policlinico San Martino Genoa

Sponsors (1)
Lead Sponsor Collaborator
Fabio Barra

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Ferrero S, Biscaldi E, Vellone VG, Venturini PL, Leone Roberti Maggiore U. Computed tomographic colonography vs rectal water- contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis: a pilot study. Ultrasound Obstet Gynecol. 2017 Apr;49(4):515-523. doi: 10.1002/uog.15905. — View Citation

Leone Roberti Maggiore U, Biscaldi E, Vellone VG, Venturini PL, Ferrero S. Magnetic resonance enema vs rectal water-contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):524-532. doi: 10.1002/uog.15934. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge At maximum 6 months before undergoing laparoscopic surgical approach
Secondary Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis At maximum 6 months before undergoing laparoscopic surgical approach
Secondary 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
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