ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
Recruiting · NCT06997809 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
pathway care
What this trial is about
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
Who can take part
Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
9 locations listed.
- Bordeaux University Hospital - Bordeaux, France, France
- IFEMENDO - Bordeaux, France, France
- Versailles Hospital - Le Chesnay, France, France
- Saint-Vincent-de-Paul Hospital - Lille, France, France
- 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