NCT04406155

Brief Summary

Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

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
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

May 25, 2020

Last Update Submit

July 23, 2020

Conditions

Endometriosis, Rectum

Keywords

rectosigmoid endometriosisbowel preparation

Outcome Measures

Primary Outcomes (1)

  • To compare the accuracy of 3D-RWC-TVS with and without bowel preparation 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 (2)

  • To compare the precision of 3D-RWC-TVS with and without bowel preparation 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 with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis.

    At maximum 6 months before laparoscopic surgical approach

Study Arms (1)

Patients with suspicion of rectosigmoid endometriosis

Procedure: 3D-RWC-TVS with bowel preparationProcedure: 3D-RWC-TVS without bowel preparation

Interventions

3D-RWC-TVS with bowel preparationPROCEDURE

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. Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.

Patients with suspicion of rectosigmoid endometriosis
3D-RWC-TVS without bowel preparationPROCEDURE

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 suspicion of rectosigmoid endometriosis

Eligibility Criteria

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

Patients with suspicion of 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

Genova, Italy

Location

Related Publications (2)

  • Ferrero S, Barra F, Stabilini C, Vellone VG, Leone Roberti Maggiore U, Scala C. Does Bowel Preparation Improve the Performance of Rectal Water Contrast Transvaginal Ultrasonography in Diagnosing Rectosigmoid Endometriosis? J Ultrasound Med. 2019 Apr;38(4):1017-1025. doi: 10.1002/jum.14790. Epub 2018 Sep 24.

    PMID: 30246880BACKGROUND

  • Ferrero S, Scala C, Stabilini C, Vellone VG, Barra F, Leone Roberti Maggiore U. Transvaginal sonography with vs without bowel preparation in diagnosis of rectosigmoid endometriosis: prospective study. Ultrasound Obstet Gynecol. 2019 Mar;53(3):402-409. doi: 10.1002/uog.19194. Epub 2019 Feb 6.

    PMID: 30079504BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Simone Ferrero, MD, PhD

    IRRCS Ospedale Policlinico San Martino

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 28, 2020

Study Start

January 1, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

IT(1)