Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

Completed

• Conditions: Endometrial Bladder Disease

• Registration Number: NCT03906760
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

Detailed Description

PURPOSE: to retrospectively evaluate on MRI the local staging with assessment of ureteral orifices extension in bladder endometriosis./ MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university Lyon hospitals were reviewed. Two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. MR images were compared with surgical and pathological findings. Efficacy parameters were calculated with 95% confidence interval (CI).

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2017-09-15
• Study Completion: 2018-09-01
• Study First Submitted: 2018-11-15
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

• Patient operated for pelvic endometriosis with bladder resection.
• Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes

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Exclusion Criteria

• Refusal to use clinical data and exploration acquired
• Absence of interpretable preoperative pelvic MRI

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of MRI data with intraoperative data and anatomopathology.	Through bladder endometriosis surgery	A bladder lesion will be retained when a signal abnormality is present on at least two different sectional planes or weights. The topography of the lesion will be related to the vesico-uterine cul-de-sac, its lateralization, its distance from the bladder neck and meatus, its size and its signal.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie; 🇫🇷 Pierre-Bénite, France