NCT03901885

Brief Summary

Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women. The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life. The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent. Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2020

Completed
Last Updated

July 27, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

April 2, 2019

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Consequences of the surgical management of a deep endometriosis on the quality of the sexual life of the patients.

    Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).

    4 months

Study Arms (1)

Major women operated for deep endometriosis

OTHER

Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).

Other: Female Sexual Function Index questionnaire

Interventions

Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).

Major women operated for deep endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).

You may not qualify if:

  • Minor patient
  • No indication for operation or indication of hysterectomy
  • Isolated uterine adenomyosis
  • Patient opposing her participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mathieu Poilblanc, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 3, 2019

Study Start

April 9, 2019

Primary Completion

February 9, 2020

Study Completion

February 9, 2020

Last Updated

July 27, 2021

Record last verified: 2021-06

Locations