About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
pathway care
Other interventionGroup 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Evaluation of satisfaction
Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year
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.
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
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.
Sponsors and contacts
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