EndometriosisECHOENDONCT05499884
Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
A study testing Endovaginal ultrasound in people with Endometriosis, run by University Hospital, Lille at 1 site in France.
Trial summary
The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Endovaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 15 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Deep pelvic endometriosis with symptomatic rectal involvement
- With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon
Who cannot join
- History of inflammatory digestive pathology
Trial locations and contacts
1 site in 1 country.
About this study
The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically
- Conditions
- Endometriosis
- Being tested
- Endovaginal ultrasound
- Keywords
- deep pelvic endometriosis, rectal shaving segmental digestive resection, endovaginal ultrasound
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovaginal ultrasoundProcedure or surgery
Endovaginal ultrasound will be performed in the operating room by the radiology team to:
- to confirm the operative indication for a rectal shaving ;
- to confirm the complete removal of the lesion
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Procedure: Endovaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)
if endovaginal ultrasound performed in the operating room (before or after shaving) modifies the choice of surgical technique in at least 2 cases out of 10, the value of endovaginal ultrasound in the operating room in the management of rectal damage by shaving will be validated
Measured: during the procedure/surgery
Secondary outcomes (1)
anatomo-pathological analysis of the operating piece.
The anatomo-pathological data will be available if the choice of surgical technique is modified following one of the endovaginal ultrasound scans carried out in the operating theatre - and therefore if a discoid or segmental resection is carried out. By confirming damage to the rectal mucosa and/or stenosis of the digestive lumen, these anatomo-pathological analyses will make it possible to validate the questioning of the choice of surgical technique.
This information is thus complementary to the main evaluation criterion, by providing an external validity criterion.
Measured: during the procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start3 Apr 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
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.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystele RUBOD, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499884
- Sponsor's protocol ID
- 2021_0273
- Other IDs
- 2022-A01264-39
- Acronym
- ECHOENDO
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2022
- Last updated
- 26 Dec 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
- ClinicalTrials.gov ID
- NCT05499884
- Acronym / sponsor ID
- ECHOENDO / 2021_0273
- Conditions
- Endometriosis
- Keywords
- deep pelvic endometriosis, rectal shaving segmental digestive resection, endovaginal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 12 Aug 2022 (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.
The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Endovaginal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Deep pelvic endometriosis with symptomatic rectal involvement
- With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon
Key exclusion criteria (1 listed)
- History of inflammatory digestive pathology
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 |
|---|---|---|
| Endovaginal ultrasoundEndovaginal ultrasound will be performed in the operating room by the radiology team to: 1. to confirm the operative indication for a rectal shaving ; 2. to confirm the complete removal of the lesion | Procedure or surgery | Experimental group |
Primary outcome
Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)
Time frame: during the procedure/surgery
if endovaginal ultrasound performed in the operating room (before or after shaving) modifies the choice of surgical technique in at least 2 cases out of 10, the value of endovaginal ultrasound in the operating room in the management of rectal damage by shaving will be validated
1 secondary outcome
anatomo-pathological analysis of the operating piece.
Time frame: during the procedure/surgery
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 26 Dec 2025.
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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.
Chrystele RUBOD, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovaginal ultrasound in people with Endometriosis, run by University Hospital, Lille at 1 site in France.
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 1 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 26 Dec 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 France. 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?
Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving) (time frame: during the procedure/surgery). 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 26 Dec 2025.