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

Completed

• Conditions: Endometriotic Parietal Involvement of the Rectosigmoid

• Registration Number: NCT03931603
• Lead Sponsor: Hospices Civils de Lyon

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.

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 Timeline

• Study Start: 2017-09-01
• Primary Completion: 2017-09-15
• Study Completion: 2018-09-15
• Study First Submitted: 2018-11-15
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-29
• Last Update Submitted: 2019-04-29
• Study First Posted: 2019-04-30
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of MRI data with intraoperative data and anatomopathology	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie; 🇫🇷 Pierre Benite, France