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Status unknownNCT043399463Dvs2D-RWC-TVSUpdated Mar 30, 2021

Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis

An observational study in Endometriosis, Rectum and Endometriosis of Colon, sponsored by Ospedale Policlinico San Martino. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Ospedale Policlinico San Martino · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Endometriosis, Rectum
  • Endometriosis of Colon

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In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 240 is above the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Ospedale Policlinico San Martino is the lead sponsor of 30 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients with clinical presentation suspected for rectosigmoid endometriosis

Inclusion criteria

  • pain and intestinal symptoms suggestive of rectosigmoid endometriosis

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testThree-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)

    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.

  • Diagnostic testTwo-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)

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

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What researchers measure

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.

    Time frame: At maximum 6 months before laparoscopic surgical approach

Secondary outcomes

  1. To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules

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

    Time frame: At maximum 6 months before laparoscopic surgical approach

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

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

    Time frame: At maximum 6 months before laparoscopic surgical approach

  3. 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

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

    Time frame: At maximum 6 months before laparoscopic surgical approach

  4. To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating rectosigmoid lumen stenosis due to endometriotic nodule

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

    Time frame: At maximum 6 months before laparoscopic surgical approach

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Study locations

1 site
  • IRCCS Ospedale Policlinico San Martino
    Genoa, 16132, Italy
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References and documents

Publications

  • 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. PubMed 20595942 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04339946
Lead sponsor
Ospedale Policlinico San Martino
Responsible party
Fabio Barra (Principal investigator, Ospedale Policlinico San Martino) — Principal investigator
First posted
Apr 9, 2020
Start date
Jan 1, 2018
Primary completion
Jan 1, 2021
Completion
Mar 1, 2022 (estimated)
Last update
Mar 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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