Endometriosis, Rectum3Dvs2D-RWC-TVSNCT04339946
Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
An observational study of Endometriosis, Rectum and Endometriosis of Colon, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Rectum, Endometriosis of Colon
- What is being tested?
- Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients with clinical presentation suspected for rectosigmoid endometriosis
Who may be able to join
- pain and intestinal symptoms suggestive of rectosigmoid endometriosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Endometriosis, Rectum, Endometriosis of Colon
- Being tested
- Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS), Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicious of rectosigmoid endometriosis | Not described Receives: Diagnostic Test: Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS); Diagnostic Test: Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The results of imaging will be compared with surgical and histological findings.
Measured: 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.
The results of imaging will be compared with surgical and histological findings.
Measured: 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
The results of imaging will be compared with surgical and histological findings.
Measured: 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
The results of imaging will be compared with surgical and histological findings.
Measured: At maximum 6 months before laparoscopic surgical approach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometriosis, RectumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339946
- Sponsor's protocol ID
- 3Dvs2D-RWC-TVS
- Acronym
- 3Dvs2D-RWC-TVS
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
- ClinicalTrials.gov ID
- NCT04339946
- Acronym / sponsor ID
- 3Dvs2D-RWC-TVS / 3Dvs2D-RWC-TVS
- Conditions
- Endometriosis, Rectum, Endometriosis of Colon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical presentation suspected for rectosigmoid endometriosis
Key inclusion criteria (1 listed)
- pain and intestinal symptoms suggestive of rectosigmoid endometriosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-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 test | Patients with suspicious of rectosigmoid endometriosis |
| Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. | Diagnostic test | Patients with suspicious of rectosigmoid endometriosis |
Primary outcome
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis.
Time frame: At maximum 6 months before laparoscopic surgical approach
The results of imaging will be compared with surgical and histological findings.
4 secondary outcomes
To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: At maximum 6 months before laparoscopic surgical approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 20595942Morotti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, Rectum and Endometriosis of Colon, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis. (time frame: At maximum 6 months before laparoscopic surgical approach). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.