ECHOENDO: Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
Study Details
Study Description
Brief 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 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group
|
Procedure: Endovaginal ultrasound
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
|
Outcome Measures
Primary Outcome Measures
- Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving) [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
Secondary Outcome Measures
- anatomo-pathological analysis of the operating piece. [during the procedure/surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
- History of inflammatory digestive pathology
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Chrystele RUBOD, MD,PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021_0273
- 2022-A01264-39