Endometriosis of the Recto-sigmoid: MRI (Magnetic Resonance Imaging) Criteria Predictive of Shaving or Segmental Resection
NCT ID: NCT03931603
Last Updated: 2019-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
61 participants
OBSERVATIONAL
2017-09-01
2018-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 61 patients treated for rectal endometriosis over a 6 years period were reviewed. Two blinded readers performed in consensus a systematic analysis of 7 rectal (length, transverse axis, thickness and circumference of the lesion, and presence of a convex base, submucosal edema and hyperintense cystic areas) and 4 pararectal (posterior vaginal fornix, parametrial, ureteral and sacro-recto-genital septum involvements) signs for each lesion. MR imaging results were compared with surgical procedure (shaving versus segmental resection). Efficacy parameters were calculated with 95 % confidence intervals (CIs).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes
Exclusion Criteria
* Absence of interpretable preoperative pelvic MRI
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie
Pierre-Bénite, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-170
Identifier Type: -
Identifier Source: org_study_id