Endometriosis RectumNCT06720688
Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity
An observational study of Endometriosis Rectum, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Association between the ultrasound appearance of deep bowel endometriosis and the frequency of pain Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis Rectum
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2024to 11 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an ultrasound diagnosis of deep bowel endometriosis undergoing surgery and patients who are not candidates for surgery
Who may be able to join
- Patients aged ≥18 years;
- Presence of posterior rectus intestinal deep endometriosis confirmed on TV ultrasound between 01/01/2018 and 30/06/2023;
- Informed consent obtained
Who cannot join
- Virgo patients;
- Patients reporting intolerance to transvaginal ultrasound;
- Current or history of gynaecological oncology;
- Previous surgery of the sigma and rectum
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Association between the ultrasound appearance of deep bowel endometriosis and the frequency of pain
Read the detailed description
In order to improve the diagnostic power of the ultrasound method, it is important to evaluate the association between the ultrasound appearance of the nodule of intestinal deep endometriosis and the frequency of pain, thus assessing the prevalence of moderate or severe clinical symptoms, in patients with newly diagnosed intestinal deep endometriosis, according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the International Deep Endometriosis Analysis Group (IDEA) Consesus.
- Conditions
- Endometriosis Rectum
- Keywords
- Endometriosis, Ultrasound, Gynaecology
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of moderate or severe clinical symptoms
Prevalence of moderate or severe clinical symptoms in patients with newly diagnosed deep bowel endometriosis according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the IDEA Consensus.
Measured: At diagnosis or in the previous 6 months
Secondary outcomes (2)
Ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions
Calculate the proportion of ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions (adenomyosis, anterior endometriosis, parametrial, LUS).
Measured: At diagnosis or in the previous 6 months
Association between ultrasound morphology and specific clinical symptoms
Check whether the different categories of ultrasound morphology, described in the IDEA Consensus, are associated with specific clinical symptoms
Measured: At diagnosis or in the previous 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start23 Mar 2024
- Primary completion30 Aug 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis RectumStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720688
- Sponsor's protocol ID
- ENDOSIGNS
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity
- ClinicalTrials.gov ID
- NCT06720688
- Acronym / sponsor ID
- ENDOSIGNS
- Conditions
- Endometriosis Rectum
- Keywords
- Endometriosis, Ultrasound, Gynaecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 6 Dec 2024 (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.
Association between the ultrasound appearance of deep bowel endometriosis and the frequency of pain
Detailed description
In order to improve the diagnostic power of the ultrasound method, it is important to evaluate the association between the ultrasound appearance of the nodule of intestinal deep endometriosis and the frequency of pain, thus assessing the prevalence of moderate or severe clinical symptoms, in patients with newly diagnosed intestinal deep endometriosis, according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the International Deep Endometriosis Analysis Group (IDEA) Consesus.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an ultrasound diagnosis of deep bowel endometriosis undergoing surgery and patients who are not candidates for surgery
Key inclusion criteria (3 listed)
- Patients aged ≥18 years;
- Presence of posterior rectus intestinal deep endometriosis confirmed on TV ultrasound between 01/01/2018 and 30/06/2023;
- Informed consent obtained
Key exclusion criteria (4 listed)
- Virgo patients;
- Patients reporting intolerance to transvaginal ultrasound;
- Current or history of gynaecological oncology;
- Previous surgery of the sigma and rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of moderate or severe clinical symptoms
Time frame: At diagnosis or in the previous 6 months
Prevalence of moderate or severe clinical symptoms in patients with newly diagnosed deep bowel endometriosis according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the IDEA Consensus.
2 secondary outcomes
Ultrasound morphologies of the intestinal endometriosis nodule and the frequency of associated lesions
Time frame: At diagnosis or in the previous 6 months
Association between ultrasound morphology and specific clinical symptoms
Time frame: At diagnosis or in the previous 6 months
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 20 Jan 2025.
Related trials for Endometriosis Rectum
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Not yet recruitingObservational study
Intraoperative Sono-assessment In Deep Endometriosis
Endometriosis, Endometriosis-related Pain
Not yet recruitingObservational study
Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis
Endometriosis, Endometriosis of Colon
Not yet recruitingObservational study
The Association Between Deep Endometriosis and the Occurrence of Colorectal Carcinoma
Endometriosis, Deep Endometriosis
RecruitingObservational study
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Endometriosis, Rectum, Endometriosis of Colon
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.
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 3 inclusion and 4 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 20 Jan 2025. 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?
Prevalence of moderate or severe clinical symptoms (time frame: At diagnosis or in the previous 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.