ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
ENDALGO
1 other identifier
interventional
187
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 30, 2025
March 1, 2025
3.5 years
February 5, 2025
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of quality of life
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
1 year after surgery
Secondary Outcomes (8)
Evaluation of satisfaction
6 months and 1 year after surgery
Evaluation of endometriosis-specific pain
From randomization to 6 months and 1 year
Evaluation of pain according to a Simple Numerical Scale (NSS)
6 months and 1 year after surgery
Improvement of EHP5 score
6 months and 1 year after surgery
Assessment of prevalence of complex pain syndrome
Baseline
- +3 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONSurgery without calculation of pain questionnaire scores
group with adapted support
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Bordeaux University Hospital
Bordeaux, France, 33000, France
IFEMENDO
Bordeaux, France, 33000, France
Versailles Hospital
Le Chesnay, France, 78150, France
Saint-Vincent-de-Paul Hospital
Lille, France, 59000, France
Limoges University hospital
Limoges, France, 87042, France
Poissy-St-Germain Intercommunal hospital center
Poissy, France, 78303, France
Poitiers University Hospital
Poitiers, France, 86000, France
Mutual Clinic La Sagesse
Rennes, France, 33043, France
South Hospital Rennes University Hospital
Rennes, France, 35203, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Dr. Margueritte
University Hospital, Limoges
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2025
First Posted
May 30, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 30, 2025
Record last verified: 2025-03