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

Not Applicable

Not yet recruiting

• Conditions: Endometriosis
• Interventions: Procedure: Endovaginal ultrasound

• Registration Number: NCT05499884
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12
• Study Start: 2022-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Endovaginal ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.