Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06997809

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Endometriosis, Pain Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pathway care

Other

Group for whom the test results will be used to determine the management strategy. If one of the tests performed before randomization is positive an algological consultation before surgery will be performed with an adapted treatment. Then surgical treatment as planned.

If all tests are negative, surgical treatment is performed. The dedicated algology consultation must be done with an experienced practitioner different from the one who will perform the surgery. A rapid algological treatment circuit must be put in place to maintain the surgery date set.

Group without using the results of test for associated pain components. Standard surgical treatment as planned through dedicated staff on endometriosis treatment.

Primary outcomes

  1. Evaluation of quality of life

    Time frame: 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 outcomes

  1. Evaluation of satisfaction

    Time frame: 6 months and 1 year after surgery

    Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year

  2. Evaluation of endometriosis-specific pain

    Time frame: 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.

  3. Evaluation of pain according to a Simple Numerical Scale (NSS)

    Time frame: 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

  4. Improvement of EHP5 score

    Time frame: 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.

  5. Assessment of prevalence of complex pain syndrome

    Time frame: 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).

  6. Assessment of determinant of complex pain syndrom of endometriosis

    Time frame: 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.

  7. Calculation of the performance of the CSI test

    Time frame: Baseline

    Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population.

  8. Calculation of performance of each test and correlation

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdeslam BEN TALEB

CONTACT

[email protected]

+33555058616

Safirah AKOWANOU

CONTACT

[email protected]

+33555058755

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: ENDALGO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.