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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
187
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.
Bordeaux University Hospital
Bordeaux, France, France
IFEMENDO
Bordeaux, France, France
Versailles Hospital
Le Chesnay, France, France
Saint-Vincent-de-Paul Hospital
Lille, France, France
Evaluation of quality of life
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
Time frame: 1 year after surgery
Evaluation of satisfaction
Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year
Time frame: 6 months and 1 year after surgery
Evaluation of endometriosis-specific pain
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.
Time frame: From randomization to 6 months and 1 year
Evaluation of pain according to a Simple Numerical Scale (NSS)
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
Time frame: 6 months and 1 year after surgery
Improvement of EHP5 score
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.
Time frame: 6 months and 1 year after surgery
Assessment of prevalence of complex pain syndrome
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).
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Limoges University hospital
Limoges, France, France
Poissy-St-Germain Intercommunal hospital center
Poissy, France, France
Poitiers University Hospital
Poitiers, France, France
Mutual Clinic La Sagesse
Rennes, France, France
South Hospital Rennes University Hospital
Rennes, France, France
Time frame: Baseline
Assessment of determinant of complex pain syndrom of endometriosis
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.
Time frame: Baseline
Calculation of the performance of the CSI test
Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population.
Time frame: Baseline
Calculation of performance of each test and correlation
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).
Time frame: Baseline