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

Endometriosis Clinical Trial

— ECHOENDO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05499884
• Other study ID #: 2021_0273
• Secondary ID: 2022-A01264-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Chrystele RUBOD, MD,PhD
• Phone: 0320445962
• Email: chrystele.rubod[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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