Status:
NOT_YET_RECRUITING
ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
Lead Sponsor:
University Hospital, Limoges
Conditions:
Endometriosis, Pain
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT06997809
Start Date
May 1 2025
End Date
November 1 2028
Last Update
May 30 2025
Active Locations (9)
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1
Bordeaux University Hospital
Bordeaux, France, France, 33000
2
IFEMENDO
Bordeaux, France, France, 33000
3
Versailles Hospital
Le Chesnay, France, France, 78150
4
Saint-Vincent-de-Paul Hospital
Lille, France, France, 59000