Back to resultsSexual Health After Endometriosis Surgery (SSACE)
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Female Sexual Function Index questionnaire
Sponsored by
About this trial
This is an interventional other trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).
Exclusion Criteria:
- Minor patient
- No indication for operation or indication of hysterectomy
- Isolated uterine adenomyosis
- Patient opposing her participation in the study
Sites / Locations
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Major women operated for deep endometriosis
Arm Description
Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03901885
Brief Title
Sexual Health After Endometriosis Surgery
Acronym
SSACE
Official Title
Impact of Deep Endometriosis Surgery on Sexual Health
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
February 9, 2020 (Actual)
Study Completion Date
February 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Major women operated for deep endometriosis
Arm Type
Other
Arm Description
Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).
Intervention Type
Other
Intervention Name(s)
Female Sexual Function Index questionnaire
Intervention Description
Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).
Primary Outcome Measure Information:
Title
Consequences of the surgical management of a deep endometriosis on the quality of the sexual life of the patients.
Description
Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).
Exclusion Criteria:
Minor patient
No indication for operation or indication of hysterectomy
Isolated uterine adenomyosis
Patient opposing her participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Poilblanc, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
12. IPD Sharing Statement
Learn more about this trial
Sexual Health After Endometriosis Surgery
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