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

Completed

• Conditions: Endometriosis Rectovaginal Septum; Endometriosis, Rectum; Endometriosis of Vagina; Endometriosis of Colon; Endometriosis Pelvic; Endometriosis

• Registration Number: NCT04296760
• Lead Sponsor: Fabio Barra

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Status Verified: 2020-11
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy