NCT03906760

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

14 days

First QC Date

November 15, 2018

Last Update Submit

April 5, 2019

Conditions

Endometrial Bladder Disease

Outcome Measures

Primary Outcomes (1)

  • Comparison of MRI data with intraoperative data and anatomopathology.

    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.

    Through bladder endometriosis surgery

Interventions

Magnetic resonance imaging (MRI)OTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

April 8, 2019

Study Start

September 1, 2017

Primary Completion

September 15, 2017

Study Completion

September 1, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)