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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Surgery without calculation of pain questionnaire scores | |
| group with adapted support | Experimental | The calculation of pain questionnaire scores is carried out to direct or not the patient towards pain consultations before surgery. Only patients with at least one positive test benefit from an algology consultation before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pathway care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of satisfaction | Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year | 6 months and 1 year after surgery |
| Evaluation of endometriosis-specific pain |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Safirah AKOWANOU | Contact | +33555058755 | safirah.akowanou@chu-limoges.fr | |
| Abdeslam BEN TALEB | Contact | +33555058616 | abdeslam.bentaleb@chu-limoges.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Dr. Margueritte | University Hospital, Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France | 33000 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019091 | Critical Pathways |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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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.
| 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 | 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. | 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). | 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. | Baseline |
| Calculation of the performance of the CSI test | Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population. | 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). | Baseline |
| IFEMENDO | Bordeaux | France | 33000 | France |
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| Versailles Hospital | Le Chesnay | France | 78150 | France |
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| Saint-Vincent-de-Paul Hospital | Lille | France | 59000 | France |
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| Limoges University hospital | Limoges | France | 87042 | France |
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| Poissy-St-Germain Intercommunal hospital center | Poissy | France | 78303 | France |
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| Poitiers University Hospital | Poitiers | France | 86000 | France |
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| Mutual Clinic La Sagesse | Rennes | France | 33043 | France |
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| South Hospital Rennes University Hospital | Rennes | France | 35203 | France |
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| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |