Endometriosis, RectumNCT04406155
Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis
An observational study of Endometriosis, Rectum, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Rectum
- What is being tested?
- 3D-RWC-TVS with bowel preparation and 3D-RWC-TVS without bowel preparation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jan 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 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: Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis
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.
Read the detailed description
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. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.
- Conditions
- Endometriosis, Rectum
- Being tested
- 3D-RWC-TVS with bowel preparation, 3D-RWC-TVS without bowel preparation
- Keywords
- rectosigmoid endometriosis, bowel preparation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-RWC-TVS with bowel preparationProcedure or surgery
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.
3D-RWC-TVS without bowel preparationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicion of rectosigmoid endometriosis | Not described Receives: Procedure: 3D-RWC-TVS with bowel preparation; Procedure: 3D-RWC-TVS without bowel preparation |
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 with and without bowel preparation 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 (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
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 with and without bowel preparation 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jan 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Investigators
- Simone Ferrero, MD, PhD, Study director, IRRCS Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406155
- Sponsor's protocol ID
- BP-3DRWC-TVS-RECTOSIG
- Status last verified
- Jul 2020
- First submitted
- 25 May 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30246880Ferrero 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.
PubMed 30079504
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis
- ClinicalTrials.gov ID
- NCT04406155
- Acronym / sponsor ID
- BP-3DRWC-TVS-RECTOSIG
- Conditions
- Endometriosis, Rectum
- Keywords
- rectosigmoid endometriosis, bowel preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 May 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.
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.
Detailed description
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. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicion of rectosigmoid endometriosis | – | Procedure: 3D-RWC-TVS with bowel preparation, Procedure: 3D-RWC-TVS without bowel preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of 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 |
|---|---|---|
| 3D-RWC-TVS with bowel preparationRectal 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. | Procedure or surgery | Patients with suspicion of rectosigmoid endometriosis |
| 3D-RWC-TVS without bowel preparationRectal 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. | Procedure or surgery | Patients with suspicion of rectosigmoid endometriosis |
Primary outcome
To compare the accuracy of 3D-RWC-TVS with and without bowel preparation 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.
2 secondary outcomes
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
Time frame: 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.
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 27 Jul 2020.
- Background: PubMed 30246880Ferrero 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.
- Background: PubMed 30079504Ferrero 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.
- 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
IRRCS 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, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia 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 27 Jul 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 with and without bowel preparation 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 NCT04406155, 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 27 Jul 2020.