ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery (ENDALGO)

University of Limoges (UL)

Status: Not yet enrolling

Conditions: Endometriosis, Pain

Treatments: Other: pathway care

Study type: Interventional

Funder types: Other

Identifiers

NCT06997809

87RI23_0049 (ENDALGO)

Details and patient eligibility

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

Enrollment: 187 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 2 patient groups

Control

No Intervention group

Description:

Surgery without calculation of pain questionnaire scores

group with adapted support

Experimental group

Description:

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.

Treatment:

Other: pathway care