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Endometriosis of the Recto-sigmoid: MRI (Magnetic Resonance Imaging) Criteria Predictive of Shaving or Segmental Resection

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ClinicalTrials.gov Identifier: NCT03931603
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment
Endometriotic Parietal Involvement of the Rectosigmoid Other: MRI

Detailed Description:

PURPOSE: To retrospectively determine the accuracy of MRI rectal and pararectal signs in predicting a segmental resection of lesions located in the rectum until the recto-sigmoid junction.

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).

Study Design
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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endometriosis of the Recto-sigmoid: MRI Criteria Predictive of Shaving or Segmental Resection
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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Intervention Details:
  • Other: MRI
    MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.

Outcome Measures
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Primary Outcome Measures :
  1. Comparison of MRI data with intraoperative data and anatomopathology [ Time Frame: Intraoperatively ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal to use clinical data and exploration acquired
  • Absence of interpretable preoperative pelvic MRI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931603


Locations
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France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie
Pierre Benite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03931603    
Other Study ID Numbers: 17-170
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis