Endometriosis of the Recto-sigmoid: MRI (Magnetic Resonance Imaging) Criteria Predictive of Shaving or Segmental Resection
1 other identifier
observational
61
1 country
1
Brief Summary
Evaluate MRI criteria predictive of the type of surgery to be performed for an "in sano" resection of endometriotic involvement of the recto-sigmoid by a resection without opening of the rectal mucosa ("shaving") versus a segmental resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedFirst Submitted
Initial submission to the registry
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedApril 30, 2019
April 1, 2019
14 days
November 15, 2018
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of MRI data with intraoperative data and anatomopathology
MRI criteria of parietal involvement will be confronted with the type of surgery performed (shaving or segmental resection) A rectosigmoid parietal involvement will be defined by the nodular replacement of the normal signal of the digestive muscularis, on at least two planes of cuts or two different weightings.
Intraoperatively
Interventions
MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.
Eligibility Criteria
Patients treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.
You may qualify if:
- operated patient for a pelvic endometriosis with resection without opening of the rectal mucosa ("shaving") or with segmental resection of the recto-sigmoidienne.
- 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
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 30, 2019
Study Start
September 1, 2017
Primary Completion
September 15, 2017
Study Completion
September 15, 2018
Last Updated
April 30, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share