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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03931603
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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	Phase
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

• 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: Sep 1, 2017
• Actual Primary Completion Date: Sep 15, 2017
• Actual Study Completion Date: Sep 15, 2018

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie	Pierre Benite		France	69310

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03931603
• Other Study ID Numbers: 17-170
• First Posted: Apr 30, 2019
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Apr 30, 2019