NCT03931603

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

14 days

First QC Date

November 15, 2018

Last Update Submit

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

MRIOTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations