NCT04339946

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

April 6, 2020

Last Update Submit

March 27, 2021

Conditions

Endometriosis, RectumEndometriosis of Colon

Outcome Measures

Primary Outcomes (1)

  • To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis.

    The results of imaging will be compared with surgical and histological findings.

    At maximum 6 months before laparoscopic surgical approach

Secondary Outcomes (4)

  • 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 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 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

Study Arms (1)

Patients with suspicious of rectosigmoid endometriosis

Diagnostic Test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)Diagnostic Test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

Interventions

Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)DIAGNOSTIC_TEST

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.

Patients with suspicious of rectosigmoid endometriosis
Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)DIAGNOSTIC_TEST

Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

Patients with suspicious of rectosigmoid endometriosis

Eligibility Criteria

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

Patients with clinical presentation suspected for rectosigmoid endometriosis

You may qualify if:

  • pain and intestinal symptoms suggestive of rectosigmoid endometriosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (1)

  • Morotti M, Ferrero S, Bogliolo S, Venturini PL, Remorgida V, Valenzano Menada M. Transvaginal ultrasonography with water-contrast in the rectum in the diagnosis of bowel endometriosis. Minerva Ginecol. 2010 Jun;62(3):179-85. English, Italian.

    PMID: 20595942BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

March 1, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

IT(1)