- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04681898
Incidence of Different Surgical Technics for Colorectal Deep Infiltrating EndoMetriosis on the Post-operative Fertility and Pregnancy Outcomes (Endo-Metrios)
Endometriosis is a disease that is very present on the current media scene. Its symptoms are very nonspecific and numerous. (dysmenorrhea, dyspareunia, dyschezia, urinary functional signs, infertility, chronic pelvic pain, etc.) Its prevalence is estimated at 10% of women and 20% of them have deep pelvic endometriosis. Colorectal lesions involving the rectosigmoid junction and the rectum represent the most severe forms and affect 5.3 to 12% of patients with deep pelvic endometriosis. Endometriosis is found in 20 to 50% of patients consulting for infertility and the rate of spontaneous pregnancy in patients with deep endometriosis is estimated to be between 8.7 and 13%. Surgery appears to improve fertility in women. However, several surgical techniques for deep endometriosis at the digestive level have been described, conservative or radical, without any having demonstrated its superiority both in terms of symptoms and fertility.
The aim of this study was to evaluate the incidence of different surgical technics (shaving vs. bowel resection) on post-operative fertility among patients with bowel deep infiltrating endometriosis and the pregnancy outcome
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Strasbourg, France, 67091
- Department of Gynecology - Strasbourg University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult woman (≥18 years old).
- woman with a desire to become pregnant and who had undergone surgery for the management of deep digestive endometriosis between September 01, 2009 and October 31, 2016.
- Woman who has not expressed, after information, the reuse of her data for the purposes of this research.
Exclusion Criteria:
- Woman who expressed her opposition to participating in the study
- Woman who had undergone a surgical intervention for the management of deep digestive endometriosis between September 01, 2009 and October 31, 2016 and having no desire to become pregnant
- Woman under safeguard of justice
- Woman under guardianship or guardianship
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Retrospective analysis of the rate of occurrence of pregnancy postoperatively.
Time Frame: Files analysed retrospectily from September 1st, 2009 to October 31, 2016 will be examined
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Files analysed retrospectily from September 1st, 2009 to October 31, 2016 will be examined
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Collaborators and Investigators
Investigators
- Study Director: Émilie FALLER, Department of Gynecology - Strasbourg University Hospitals
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8088
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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