Clinical trial NCT06997809: ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
Official title: ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis, Pain
Keywords: endometriosis, algologic care
pain, quality of life
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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: 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

Primary outcomes:
measure: Evaluation of quality of life
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Evaluation of satisfaction
timeFrame: 6 months and 1 year after surgery
measure: Evaluation of endometriosis-specific pain
timeFrame: From randomization to 6 months and 1 year
measure: Evaluation of pain according to a Simple Numerical Scale (NSS)
timeFrame: 6 months and 1 year after surgery
measure: Improvement of EHP5 score
timeFrame: 6 months and 1 year after surgery
measure: Assessment of prevalence of complex pain syndrome
timeFrame: Baseline
measure: Assessment of determinant of complex pain syndrom of endometriosis
timeFrame: Baseline
measure: Calculation of the performance of the CSI test
timeFrame: Baseline
measure: Calculation of performance of each test and correlation
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Bordeaux
country: France
facility: IFEMENDO
city: Le Chesnay
country: France
facility: Versailles Hospital
city: Lille
country: France
facility: Saint-Vincent-de-Paul Hospital
city: Limoges
country: France
facility: Limoges University hospital
city: Poissy
country: France
facility: Poissy-St-Germain Intercommunal hospital center
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Mutual Clinic La Sagesse
city: Rennes
country: France
facility: South Hospital Rennes University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: François Dr. Margueritte
role: PRINCIPAL_INVESTIGATOR
References: