NCT04681898

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

December 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 31, 2022

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

December 18, 2020

Last Update Submit

January 25, 2022

Conditions

Keywords

colorectal endometriosisdeep infiltrating endometriosisfertilitysurgical technics in endometriosis

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of the rate of occurrence of pregnancy postoperatively.

    Files analysed retrospectily from September 1st, 2009 to October 31, 2016 will be examined

Eligibility Criteria

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

Adult 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology - Strasbourg University Hospitals

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Émilie FALLER

    Department of Gynecology - Strasbourg University Hospitals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2020

First Posted

December 23, 2020

Study Start

December 30, 2020

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

January 31, 2022

Record last verified: 2020-11

Locations