ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 27
- 主要终点
- Evaluation of quality of life
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
group with adapted support
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.
干预措施: pathway care (Other)
Control
Surgery without calculation of pain questionnaire scores
结局指标
主要结局
Evaluation of quality of life
时间窗: 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
次要结局
- Evaluation of satisfaction(6 months and 1 year after surgery)
- Evaluation of endometriosis-specific pain(From randomization to 6 months and 1 year)
- Evaluation of pain according to a Simple Numerical Scale (NSS)(6 months and 1 year after surgery)
- Improvement of EHP5 score(6 months and 1 year after surgery)
- Assessment of prevalence of complex pain syndrome(Baseline)
- Assessment of determinant of complex pain syndrom of endometriosis(Baseline)
- Calculation of the performance of the CSI test(Baseline)
- Calculation of performance of each test and correlation(Baseline)