Endometriosis, Pain
Conditions
Keywords
endometriosis, algologic care, pain, quality of life
Brief summary
Endometriosis surgery is required when medical treatment fails to release women from pain. However, complete surgery does not work every time to improve patients' symptoms. Algological care is one of the options to treat the pain before surgery and their related complications (neuropathy, sensitization, and catastrophism) that could be associated to nociceptive pain. But not all patients could benefit from this pathway and no screening strategy does exist to detect these complications that could be treated prior to endometriosis surgery
Interventions
OTHERpathway care
Group for whom the test results will be used to determine the management strategy. If one of the tests performed before randomization is positive an algological consultation before surgery will be performed with an adapted treatment. Then surgical treatment as planned. If all tests are negative, surgical treatment is performed. The dedicated algology consultation must be done with an experienced practitioner different from the one who will perform the surgery. A rapid algological treatment circuit must be put in place to maintain the surgery date set. Group without using the results of test for associated pain components. Standard surgical treatment as planned through dedicated staff on endometriosis treatment.
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Maternal age from 18 up to 50 years old (50 non included). * Women affiliated to social coverage insurance * Women who understand French * Women who signed the written consent * Women with impaired quality of life (pain) linked to endometriosis * Women with formal radiological signs of endometriosis (MRI lesions more than 5 mm or endometrioma more than 20 mm on radiological examinations). * Surgical indication for resection of lesions by laparoscopy or robotic surgery for management of pain or impairment of quality of life * Patients requiring complete conservative or radical resections of all lesions * Indication of surgery validated within dedicated meeting for endometriosis. * Purpose of pain associated or not with infertility * Date of surgery fixed with sufficient time for algological treatment. Maximum delay of 4 months between randomization and surgery
Exclusion criteria
* Women undergoing surgery for the purpose of infertility * Patient with previous surgery for removal of deep lesions of endometriosis or endometriotic cysts (history of exploratory laparoscopy accepted) * Patient with suspicious lesions on MRI or specialized ultrasound. * A patient who needs to be treated for another uterine pathology at the same time. * Pregnant women * Patient with a desire for pregnancy immediately and/or within one year after surgery * Women who refuse clinical examination (some algological tests couldn't be performed without clinical examination) * Patient who has already received algological treatment or who should receive it before surgery * Patient with previous other psychiatric disorders (depressive symptoms treated) * Women without rights
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of quality of life | 1 year after surgery | Quality of life is assessed by the EHP5 score translated in French and validated in endometriosis. The primary endpoint is the comparison of EHP5 scores between the 2 groups (intervention vs. standard treatment) at 1 year after surgery for complete removal of deep endometriosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of satisfaction | 6 months and 1 year after surgery | Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year |
| Evaluation of endometriosis-specific pain | From randomization to 6 months and 1 year | Evaluation of endometriosis-specific pain according to the ENDOPAIN 4D score (which vary from 0 (no pain component) up to 110 (worst pain component)) before randomization and after surgery performed in all cases at 6 months and 1 year. |
| Evaluation of pain according to a Simple Numerical Scale (NSS) | 6 months and 1 year after surgery | Evaluation of their score difference (2) and evaluation of pain according to a Simple Numerical Scale (NSS) ( from 0 (no pain) up to 10 (worst pain) before / after surgery at 6 months and 1 year |
| Improvement of EHP5 score | 6 months and 1 year after surgery | Improvement of Endometriosis Health Profile (EHP5) score (from 0 (best quality of life) up to 100 (worst quality of life)) at 6 months and 1 year and difference between the beginning and between the two groups. |
| Assessment of prevalence of complex pain syndrome | Baseline | Assessment of prevalence of complex pain syndrome in the whole population included: neuropathic pain (DN4 (from 0 (no symptoms) up to 10 (the most symptoms)) and PainDETECT score (from 0 (no probability of neuropathic pain unlikely) up to 38 (probability of neuropathic pain more likely)), sensitization (peripheral and central with Perineal Pain Sensitization Criteria (PPSC) (from 0 (no criteri) up to 10 (all criteria)) and Central Sensitization Inventory (CSI) score (from 0 ( no component) up to 100 (always and all components), associated catastrophizing (Pain Catastrophizing Score (PCS) (from 0 (no catastrophizing compenent) up to 52 (always and all catastrophizing components). |
| Assessment of determinant of complex pain syndrom of endometriosis | Baseline | Assessment of determinants (previous medical conditions, demographical medical data and previous treatment before surgery) of complex pain syndrome of endometriosis (as describe in previous secondary outcome) with statistical modelization. |
| Calculation of the performance of the CSI test | Baseline | Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population. |
| Calculation of performance of each test and correlation | Baseline | Calculation of the performance of each test proposed before randomization (DN4, PainDETECT, PPSC and PCS score) (prevalence) and correlation (kappa correlation) for neuropathic pain (DN4 and PainDETECT). |
Countries
France
Contacts
CONTACTSafirah AKOWANOU
CONTACTAbdeslam BEN TALEB
PRINCIPAL_INVESTIGATORFrançois Dr. Margueritte
University Hospital, Limoges
Outcome results
None listed