Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis

Study Overview
=================
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

Official Title
-----------------
Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Procedure: Endovaginal ultrasound


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Procedure: Endovaginal ultrasound<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during the procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the procedure/surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep pelvic endometriosis, rectal shaving segmental digestive resection, endovaginal ultrasound