Endometriosis, SigmoidNCT04295343
Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
An observational study of Endometriosis, Sigmoid and Endometriosis, Rectum, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Sigmoid, Endometriosis, Rectum
- What is being tested?
- Three-dimensional (3D) rectal water contrast transvaginal ultrasonography and Computed colonography
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 1 Feb 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
- Healthy volunteers accepted
- 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
Official title: Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.
- Conditions
- Endometriosis, Sigmoid, Endometriosis, Rectum
- Being tested
- Three-dimensional (3D) rectal water contrast transvaginal ultrasonography, Computed colonography
- Keywords
- Rectosigmoid endometriosis
- 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 (3D) rectal water contrast transvaginal ultrasonographyDiagnostic 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.
Computed colonographyDiagnostic test
Computed colonography or virtual colonoscopy uses special x-ray equipment to examine the large intestine. During the exam, a small tube is inserted a short distance into the rectum to allow for inflation with gas while computed tomographic images of the colon and the rectum are taken.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicious of rectosigmoid endometriosis | Not described Receives: Diagnostic Test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography; Diagnostic Test: Computed colonography |
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 CTC 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 (3)
To compare the precision of 3D-RWC-TVS and CTC 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 CTC 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 CTC 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2017
- Primary completion1 Sep 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometriosis, SigmoidStudies 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
- 68 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
- Investigators
- Simone Ferrero, MD, PhD, Study director, IRCCS Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295343
- Sponsor's protocol ID
- 3dETV-CTC-ENDO
- Status last verified
- May 2020
- First submitted
- 2 Mar 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferrero 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 26935873Morotti 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 20595942Barra F, Biscaldi E, Scala C, Lagana AS, Vellone VG, Stabilini C, Ghezzi F, Ferrero S. A Prospective Study Comparing Three-Dimensional Rectal Water Contrast Transvaginal Ultrasonography and Computed Tomographic Colonography in the Diagnosis of Rectosigmoid Endometriosis. Diagnostics (Basel). 2020 Apr 24;10(4):252. doi: 10.3390/diagnostics10040252.
PubMed 32344709
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
- ClinicalTrials.gov ID
- NCT04295343
- Acronym / sponsor ID
- 3dETV-CTC-ENDO
- Conditions
- Endometriosis, Sigmoid, Endometriosis, Rectum
- Keywords
- Rectosigmoid endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 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.
Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.
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 (3D) rectal water contrast transvaginal ultrasonography, Diagnostic Test: Computed colonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- 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 (3D) rectal water contrast transvaginal ultrasonographyRectal 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 |
| Computed colonographyComputed colonography or virtual colonoscopy uses special x-ray equipment to examine the large intestine. During the exam, a small tube is inserted a short distance into the rectum to allow for inflation with gas while computed tomographic images of the colon and the rectum are taken. | Diagnostic test | Patients with suspicious of rectosigmoid endometriosis |
Primary outcome
To compare the accuracy of 3D-RWC-TVS and CTC 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.
3 secondary outcomes
To compare the precision of 3D-RWC-TVS and CTC 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 CTC 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 CTC 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
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 1 Jun 2020.
- 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.
- 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.
- Results publication: PubMed 32344709Barra F, Biscaldi E, Scala C, Lagana AS, Vellone VG, Stabilini C, Ghezzi F, Ferrero S. A Prospective Study Comparing Three-Dimensional Rectal Water Contrast Transvaginal Ultrasonography and Computed Tomographic Colonography in the Diagnosis of Rectosigmoid Endometriosis. Diagnostics (Basel). 2020 Apr 24;10(4):252. doi: 10.3390/diagnostics10040252.
- 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.
Simone Ferrero, MD, PhD study director
IRCCS 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, Sigmoid and Endometriosis, Rectum, 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: finished, as of the sponsor's last update on 1 Jun 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?
To compare the accuracy of 3D-RWC-TVS and CTC 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 NCT04295343, which also lists 3 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 1 Jun 2020.