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Completed

NCT Number: NCT03906760

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie

Pierre-Bénite, 69310, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

magnetic resonance imaging (MRI)

Other

MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.

Primary outcomes

  1. Comparison of MRI data with intraoperative data and anatomopathology.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 8, 2019
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.