EndometriosisNCT07900698
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
An observational study of Endometriosis and Endometriosis Rectum, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This retrospective single-centre study evaluates how accurately preoperative ultrasound detects bowel involvement in women with deep endometriosis, using surgical findings as the reference. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis Rectum, Endometriosis Pelvic
- What is being tested?
- preoperative transvaginal ultrasound
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Oct 2026to 30 Oct 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Women operated for deep endometriosis at the Endometriosis Clinic of Hôpital Erasme (Brussels) between 2018 and 2028
Who may be able to join
- Women aged 18 years or older
- Preoperative ultrasound performed at the Endometriosis Clinic of Hôpital Erasme
- Surgery for deep endometriosis at Hôpital Erasme between 2018 and 2028, with bowel endometriosis confirmed by histopathology
- Operative report available
Who cannot join
- Missing or incomplete preoperative ultrasound or operative report or histology
- Patient opposition to the use of her medical data for research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Hôpital Erasme - Hôpital Universitaire de Bruxelles (HUB)
Brussels, Belgium, 1070
Giulia GG Garofalo, 0032486306746, giulia.garofalo@hubruxelles.be
Laura LC Cacciamani, 00393201536657
About this study
Official title: Transvaginal Ultrasound in Bowel Endometriosis: a Retrospective Study of 10 Years on the Clinical Impact of Preoperative Diagnosis
This retrospective single-centre study evaluates how accurately preoperative ultrasound detects bowel involvement in women with deep endometriosis, using surgical findings as the reference. It also assesses whether ultrasound correctly locates and measures bowel lesions, and whether ultrasound lesion size predicts the type of bowel surgery performed (shaving, discoid excision or segmental resection). Data come from the medical records of patients operated at the Endometriosis Clinic of Hôpital Erasme, Brussels.
Read the detailed description
Deep endometriosis involving the bowel requires accurate preoperative mapping to plan surgery and counsel patients. Expert transvaginal ultrasound is recommended as a first-line imaging tool, but its real-world diagnostic performance and its value for predicting the surgical technique need further evaluation.
This is a retrospective, observational, single-centre cohort study. Patients who underwent surgery for suspected or confirmed deep endometriosis at the Endometriosis Clinic of Hôpital Erasme (HUB, Brussels) between 2018 and 2028 will be identified from the clinic database. Preoperative ultrasound reports will be compared with operative reports and histopathology.
Collected variables include ultrasound presence, location and size of bowel lesions; surgical findings and technique (shaving, discoid excision, segmental resection); and histopathological lesion size. No additional examinations or contacts with patients are planned. A waiver of informed consent has been requested from the Ethics Committee given the retrospective design.
A preliminary analysis covering patients operated between 2018 and 2025 will be performed first.
- Being tested
- preoperative transvaginal ultrasound
- Keywords
- transvaginal ultrasound, deep infiltrating endometriosis, bowel endometriosis, retrospective study, preoperative imaging, segmental resection, shaving, discoid resection
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative transvaginal ultrasoundDiagnostic test
Routine preoperative ultrasound performed as part of standard care in patients with a suspected deep infiltrating endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for deep endometriosis with suspected bowel involvement | Women who had a preoperative expert ultrasound and surgery at the Endometriosis Clinic of Hôpital Erasme between 2018 and 2028 Receives: Diagnostic Test: preoperative transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Transvaginal Ultrasound for Bowel Endometriosis Compared With Surgical Findings Confirmed by Histopathology
Percentage of patients with bowel endometriosis found at surgery (operative report) and confirmed by histopathology who were correctly identified as having bowel involvement on preoperative transvaginal ultrasound. Unit: % of patients.
Measured: From preoperative transvaginal ultrasound to surgery and histopathology report, up to 24 months (an average of 3 months)
Secondary outcomes (3)
Percentage of Bowel Lesions With Concordant Location on Transvaginal Ultrasound and at Surgery
Percentage of surgically confirmed bowel lesions whose location on preoperative transvaginal ultrasound (rectum, rectosigmoid junction, sigmoid colon) matches the location described in the operative report. Unit: % of lesions.
Measured: From preoperative transvaginal ultrasound to surgery, up to 24 months (an average of 3 months)
Correlation Between Bowel Lesion Diameter on Transvaginal Ultrasound and on Histopathology
Spearman's rank correlation coefficient between the largest bowel lesion diameter measured on preoperative transvaginal ultrasound (mm) and the largest lesion diameter measured on the histopathology report (mm). Unit: Spearman's rho.
Measured: From preoperative transvaginal ultrasound to histopathology report, up to 24 months (an average of 3 months)
Percentage of Patients Undergoing Segmental Resection According to the Largest Axis of the Bowel Lesion on Transvaginal Ultrasound (< 3 cm vs ≥ 3 cm)
Percentage of patients treated by segmental bowel resection, the most radical surgical technique, versus conservative techniques (shaving or discoid excision), as recorded in the operative report, in the group with a bowel lesion largest axis < 3 cm on preoperative transvaginal ultrasound and in the group with a largest axis ≥ 3 cm. This outcome aims to assess whether lesion size on ultrasound can predict the need for the most radical surgery. Unit: % of patients.
Measured: From preoperative transvaginal ultrasound to surgery, up to 24 months (an average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900698
- Sponsor's protocol ID
- HUB20260747
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data come from hospital medical records and will not be shared, in line with GDPR and the ethics approval
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound in Bowel Endometriosis: a Retrospective Study of 10 Years on the Clinical Impact of Preoperative Diagnosis
- ClinicalTrials.gov ID
- NCT07900698
- Acronym / sponsor ID
- HUB20260747
- Keywords
- transvaginal ultrasound, deep infiltrating endometriosis, bowel endometriosis, retrospective study, preoperative imaging, segmental resection, shaving, discoid resection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2035 (estimated)
- First posted
- 28 Oct 2026 (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.
This retrospective single-centre study evaluates how accurately preoperative ultrasound detects bowel involvement in women with deep endometriosis, using surgical findings as the reference. It also assesses whether ultrasound correctly locates and measures bowel lesions, and whether ultrasound lesion size predicts the type of bowel surgery performed (shaving, discoid excision or segmental resection). Data come from the medical records of patients operated at the Endometriosis Clinic of Hôpital Erasme, Brussels.
Detailed description
Deep endometriosis involving the bowel requires accurate preoperative mapping to plan surgery and counsel patients. Expert transvaginal ultrasound is recommended as a first-line imaging tool, but its real-world diagnostic performance and its value for predicting the surgical technique need further evaluation.
This is a retrospective, observational, single-centre cohort study. Patients who underwent surgery for suspected or confirmed deep endometriosis at the Endometriosis Clinic of Hôpital Erasme (HUB, Brussels) between 2018 and 2028 will be identified from the clinic database. Preoperative ultrasound reports will be compared with operative reports and histopathology.
Collected variables include ultrasound presence, location and size of bowel lesions; surgical findings and technique (shaving, discoid excision, segmental resection); and histopathological lesion size. No additional examinations or contacts with patients are planned. A waiver of informed consent has been requested from the Ethics Committee given the retrospective design.
A preliminary analysis covering patients operated between 2018 and 2025 will be performed first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for deep endometriosis with suspected bowel involvement | – | Diagnostic Test: preoperative transvaginal ultrasoundWomen who had a preoperative expert ultrasound and surgery at the Endometriosis Clinic of Hôpital Erasme between 2018 and 2028 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women operated for deep endometriosis at the Endometriosis Clinic of Hôpital Erasme (Brussels) between 2018 and 2028
Key inclusion criteria (4 listed)
- Women aged 18 years or older
- Preoperative ultrasound performed at the Endometriosis Clinic of Hôpital Erasme
- Surgery for deep endometriosis at Hôpital Erasme between 2018 and 2028, with bowel endometriosis confirmed by histopathology
- Operative report available
Key exclusion criteria (2 listed)
- Missing or incomplete preoperative ultrasound or operative report or histology
- Patient opposition to the use of her medical data for research
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 |
|---|---|---|
| preoperative transvaginal ultrasoundRoutine preoperative ultrasound performed as part of standard care in patients with a suspected deep infiltrating endometriosis | Diagnostic test | Patients operated for deep endometriosis with suspected bowel involvement |
Primary outcome
Sensitivity of Transvaginal Ultrasound for Bowel Endometriosis Compared With Surgical Findings Confirmed by Histopathology
Time frame: From preoperative transvaginal ultrasound to surgery and histopathology report, up to 24 months (an average of 3 months)
Percentage of patients with bowel endometriosis found at surgery (operative report) and confirmed by histopathology who were correctly identified as having bowel involvement on preoperative transvaginal ultrasound. Unit: % of patients.
3 secondary outcomes
Percentage of Bowel Lesions With Concordant Location on Transvaginal Ultrasound and at Surgery
Time frame: From preoperative transvaginal ultrasound to surgery, up to 24 months (an average of 3 months)
Correlation Between Bowel Lesion Diameter on Transvaginal Ultrasound and on Histopathology
Time frame: From preoperative transvaginal ultrasound to histopathology report, up to 24 months (an average of 3 months)
Percentage of Patients Undergoing Segmental Resection According to the Largest Axis of the Bowel Lesion on Transvaginal Ultrasound (< 3 cm vs ≥ 3 cm)
Time frame: From preoperative transvaginal ultrasound to surgery, up to 24 months (an average of 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual data come from hospital medical records and will not be shared, in line with GDPR and the ethics approval
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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.
Hôpital Erasme - Hôpital Universitaire de Bruxelles (HUB)
Brussels, Belgium
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 and Endometriosis Rectum, run by Erasme University Hospital at 1 site in Belgium.
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 4 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Transvaginal Ultrasound for Bowel Endometriosis Compared With Surgical Findings Confirmed by Histopathology (time frame: From preoperative transvaginal ultrasound to surgery and histopathology report, up to 24 months (an average of 3 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 28 Oct 2026.