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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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