NCT04296760

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

March 3, 2020

Last Update Submit

November 16, 2020

Conditions

Endometriosis, RectumEndometriosis of VaginaEndometriosis Rectovaginal SeptumEndometriosis PelvicEndometriosis of ColonEndometriosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

Study Arms (1)

Women with suspicious of deep posterior pelvic endometriosis

Diagnostic Test: Rectal water-contrast transvaginal ultrasonographyDiagnostic Test: Sonovaginography

Interventions

Rectal water-contrast transvaginal ultrasonographyDIAGNOSTIC_TEST

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

Women with suspicious of deep posterior pelvic endometriosis
SonovaginographyDIAGNOSTIC_TEST

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

Women with suspicious of deep posterior pelvic endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes

You may qualify if:

  • clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis

You may not qualify if:

  • previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
  • previous surgical diagnosis of posterior deep infiltrating endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Policlinico San Martino

Genoa, 1632, Italy

Location

Related Publications (2)

  • 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.

    PMID: 27060846BACKGROUND

  • 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.

    PMID: 26935873BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Fabio Barra, MD

    Ospedale Policlinico San Martino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

January 1, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

IT(1)