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Sexual Health After Endometriosis Surgery (SSACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901885
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometriosis Other: Female Sexual Function Index questionnaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Deep Endometriosis Surgery on Sexual Health
Actual Study Start Date : April 9, 2019
Actual Primary Completion Date : February 9, 2020
Actual Study Completion Date : February 9, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Major women operated for deep endometriosis
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
Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).


Outcome Measures
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Primary Outcome Measures :
  1. Consequences of the surgical management of a deep endometriosis on the quality of the sexual life of the patients. [ Time Frame: 4 months ]
    Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901885


Locations
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France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Mathieu Poilblanc, MD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03901885    
Other Study ID Numbers: 69HCL18_0656
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis