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

Not Applicable

Not yet recruiting

• Conditions: Endometriosis, Pain

• Registration Number: NCT06997809
• Lead Sponsor: University Hospital, Limoges

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-05
• Status Verified: 2025-03
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 187

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of quality of life	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

Secondary Outcome Measures

Name	Time	Method
Calculation of performance of each test and correlation	Baseline	Calculation of the performance of each test proposed before randomization (DN4, PainDETECT, PPSC and PCS score) (prevalence) and correlation (kappa correlation) for neuropathic pain (DN4 and PainDETECT).
Calculation of the performance of the CSI test	Baseline	Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population.
Evaluation of satisfaction	6 months and 1 year after surgery	Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year
Evaluation of endometriosis-specific pain	From randomization to 6 months and 1 year	Evaluation of endometriosis-specific pain according to the ENDOPAIN 4D score (which vary from 0 (no pain component) up to 110 (worst pain component)) before randomization and after surgery performed in all cases at 6 months and 1 year.
Evaluation of pain according to a Simple Numerical Scale (NSS)	6 months and 1 year after surgery	Evaluation of their score difference (2) and evaluation of pain according to a Simple Numerical Scale (NSS) ( from 0 (no pain) up to 10 (worst pain) before / after surgery at 6 months and 1 year
Improvement of EHP5 score	6 months and 1 year after surgery	Improvement of Endometriosis Health Profile (EHP5) score (from 0 (best quality of life) up to 100 (worst quality of life)) at 6 months and 1 year and difference between the beginning and between the two groups.
Assessment of prevalence of complex pain syndrome	Baseline	Assessment of prevalence of complex pain syndrome in the whole population included: neuropathic pain (DN4 (from 0 (no symptoms) up to 10 (the most symptoms)) and PainDETECT score (from 0 (no probability of neuropathic pain unlikely) up to 38 (probability of neuropathic pain more likely)), sensitization (peripheral and central with Perineal Pain Sensitization Criteria (PPSC) (from 0 (no criteri) up to 10 (all criteria)) and Central Sensitization Inventory (CSI) score (from 0 ( no component) up to 100 (always and all components), associated catastrophizing (Pain Catastrophizing Score (PCS) (from 0 (no catastrophizing compenent) up to 52 (always and all catastrophizing components).
Assessment of determinant of complex pain syndrom of endometriosis	Baseline	Assessment of determinants (previous medical conditions, demographical medical data and previous treatment before surgery) of complex pain syndrome of endometriosis (as describe in previous secondary outcome) with statistical modelization.

Trial Locations

Locations (9)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

IFEMENDO; 🇫🇷 Bordeaux, France

Versailles Hospital; 🇫🇷 Le Chesnay, France

Saint-Vincent-de-Paul Hospital; 🇫🇷 Lille, France

Limoges University hospital; 🇫🇷 Limoges, France

Poissy-St-Germain Intercommunal hospital center; 🇫🇷 Poissy, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Mutual Clinic La Sagesse; 🇫🇷 Rennes, France

South Hospital Rennes University Hospital; 🇫🇷 Rennes, France