Endometriosis, RectumNCT04296760
Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
An observational study of Endometriosis, Rectum and Endometriosis of Vagina, run by Fabio Barra at 1 site in Italy.
Trial 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… 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 Vagina, Endometriosis Rectovaginal Septum
- What is being tested?
- Rectal water-contrast transvaginal ultrasonography and Sonovaginography
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Nov 2020
- 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 suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes
Who may be able to join
- clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis
Who cannot join
- previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
- previous surgical diagnosis of posterior deep infiltrating endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Endometriosis, Rectum, Endometriosis of Vagina, Endometriosis Rectovaginal Septum, Endometriosis Pelvic, Endometriosis of Colon, Endometriosis
- Being tested
- Rectal water-contrast transvaginal ultrasonography, Sonovaginography
- Keywords
- rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal water-contrast transvaginal ultrasonographyDiagnostic test
Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum
SonovaginographyDiagnostic test
Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina
| Study group | Role | What they receive |
|---|---|---|
| Women with suspicious of deep posterior pelvic endometriosis | Not described Receives: Diagnostic Test: Rectal water-contrast transvaginal ultrasonography; Diagnostic Test: Sonovaginography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
Measured: 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
Measured: At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge
Measured: At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis
Measured: 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
Measured: At maximum 6 months before undergoing 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 posted5 Mar 2020
- Study start1 Jan 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Barra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Barra, Ospedale Policlinico San Martino
- Investigators
- Fabio Barra, MD, Principal investigator, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296760
- Sponsor's protocol ID
- ENHANCED-ETV-ENDO
- Status last verified
- Nov 2020
- First submitted
- 3 Mar 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27060846Ferrero 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.
PubMed 26935873
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
- ClinicalTrials.gov ID
- NCT04296760
- Acronym / sponsor ID
- ENHANCED-ETV-ENDO
- Conditions
- Endometriosis, Rectum, Endometriosis of Vagina, Endometriosis Rectovaginal Septum, Endometriosis Pelvic, Endometriosis of Colon, Endometriosis
- Keywords
- rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Fabio BarraUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 5 Mar 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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with suspicious of deep posterior pelvic endometriosis | – | Diagnostic Test: Rectal water-contrast transvaginal ultrasonography, Diagnostic Test: Sonovaginography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes
Key inclusion criteria (1 listed)
- clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis
Key exclusion criteria (2 listed)
- previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
- previous surgical diagnosis of posterior deep infiltrating endometriosis
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 |
|---|---|---|
| Rectal water-contrast transvaginal ultrasonographyTransvaginal ultrasound scan combined with the introduction of saline solution into the rectum | Diagnostic test | Women with suspicious of deep posterior pelvic endometriosis |
| SonovaginographyTransvaginal ultrasound scan combined with the introduction of saline solution into the vagina | Diagnostic test | Women with suspicious of deep posterior pelvic endometriosis |
Primary outcome
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
Time frame: At maximum 6 months before undergoing laparoscopic surgical approach
4 secondary outcomes
Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis
Time frame: At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge
Time frame: At maximum 6 months before undergoing laparoscopic surgical approach
Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis
Time frame: 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
Time frame: At maximum 6 months before undergoing laparoscopic surgical approach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 27060846Leone 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.
- Background: PubMed 26935873Ferrero 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.
- 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.
Fabio Barra, MD principal investigator
Ospedale Policlinico San Martino
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 Vagina, run by Fabio Barra 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 2 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: finished, as of the sponsor's last update on 17 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina (time frame: At maximum 6 months before undergoing 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 NCT04296760, which also lists 2 linked publications.
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 17 Nov 2020.