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

Endometriotic Parietal Involvement of the Rectosigmoid Clinical Trial

Official title:

Endometriosis of the Recto-sigmoid: MRI Criteria Predictive of Shaving or Segmental Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931603
• Other study ID #: 17-170
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 15, 2018

Study information

• Verified date: April 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriotic Parietal Involvement of the Rectosigmoid

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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