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Not yet recruiting NCT06997809

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

No phase Interventional Endometriosis, Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pathway care.
Who it may be relevant to
Registry conditions: Endometriosis, Pain. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other pathway care
    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 circ

Primary outcome measures

  • Evaluation of quality of life [Time frame: 1 year after surgery]
Secondary outcome measures (8)
  • Evaluation of satisfaction [Time frame: 6 months and 1 year after surgery]
  • Evaluation of endometriosis-specific pain [Time frame: From randomization to 6 months and 1 year]
  • Evaluation of pain according to a Simple Numerical Scale (NSS) [Time frame: 6 months and 1 year after surgery]
  • Improvement of EHP5 score [Time frame: 6 months and 1 year after surgery]
  • Assessment of prevalence of complex pain syndrome [Time frame: Baseline]
  • Assessment of determinant of complex pain syndrom of endometriosis [Time frame: Baseline]
  • Calculation of the performance of the CSI test [Time frame: Baseline]
  • Calculation of performance of each test and correlation [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

France · 9 centers
  • Bordeaux University Hospital — Bordeaux
  • IFEMENDO — Bordeaux
  • Versailles Hospital — Le Chesnay
  • Saint-Vincent-de-Paul Hospital — Lille
  • Limoges University hospital — Limoges
  • Poissy-St-Germain Intercommunal hospital center — Poissy
  • Poitiers University Hospital — Poitiers
  • Mutual Clinic La Sagesse — Rennes
  • … and 1 more center

Identifiers

NCT: NCT06997809 · 87RI23_0049 (ENDALGO)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗