Endometriosis, PainENDALGONCT06997809
ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
A study testing pathway care in people with Endometriosis, Pain, run by University Hospital, Limoges at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Pain
- What is being tested?
- pathway care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Aug 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Bordeaux University Hospital
Bordeaux, France, 33000
Valérie BERNARD, 05 57 62 34 72, valerie.bernard@chu-bordeaux.fr
Valérie BERNARD
- Not yet recruiting
IFEMENDO
Bordeaux, France, 33000
Horace ROMAN, 06 50 13 92 54, horace.roman@gmail.com
Horace ROMAN
- Not yet recruiting
Versailles Hospital
Le Chesnay, France, 78150
Pierre PANEL, 01 39 63 97 33, ppanel@ght78sud.fr
Pierre PANEL
- Not yet recruiting
Saint-Vincent-de-Paul Hospital
Lille, France, 59000
Jean-Philippe LUCOT, 03 20 00 45 52, lucot.jean-philippe@ghicl.net
Jean-Philippe LUCOT
- Recruiting
Limoges University hospital
Limoges, France, 87042
Francois MARGUERITTE, 0555056164, francois.margueritte@chu-limoges.fr
Francois Margueritte
- Not yet recruiting
Poissy-St-Germain Intercommunal hospital center
Poissy, France, 78303
Arnaud FAUCONNIER, 01 39 27 52 51, arnaud.fauconnier@ght-yvelinesnord.fr
Arnaud FAUCONNIER
- Not yet recruiting
Poitiers University Hospital
Poitiers, France, 86000
Xavier FRITEL, 05 49 44 39 45, xavier.fritel@univ-poitiers.fr
Xavier FRITEL
- Not yet recruiting
Mutual Clinic La Sagesse
Rennes, France, 33043
Claire-Marie ROGER, 02 99 85 77 92, clairemarie.roger@hospigrandouest.fr
Claire-Marie ROGER
- Not yet recruiting
South Hospital Rennes University Hospital
Rennes, France, 35203
Krystel NYANGOH TIMOH, 06 72 13 60 50, krystel.nyangoh.timoh@chu-rennes.fr
Krystel NYANGOH TIMOH
About this study
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
- Conditions
- Endometriosis, Pain
- Being tested
- pathway care
- Keywords
- endometriosis, algologic care, pain, quality of life
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathway careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Surgery without calculation of pain questionnaire scores |
| group with adapted support | Experimental | The 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. Receives: Other: pathway care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after surgery
Secondary outcomes (8)
Evaluation of satisfaction
Evaluation of satisfaction according to the CGI (Clinical Global Impression), at 6 months and 1 year
Measured: 6 months and 1 year after surgery
Evaluation of endometriosis-specific pain
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.
Measured: From randomization to 6 months and 1 year
Evaluation of pain according to a Simple Numerical Scale (NSS)
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
Measured: 6 months and 1 year after surgery
Improvement of EHP5 score
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.
Measured: 6 months and 1 year after surgery
Assessment of prevalence of complex pain syndrome
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).
Measured: Baseline
Assessment of determinant of complex pain syndrom of endometriosis
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.
Measured: Baseline
Calculation of the performance of the CSI test
Calculation of the performance (sensitivity, specificity, prevalence, accuracy) of the CSI test within this population.
Measured: Baseline
Calculation of performance of each test and correlation
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start5 Aug 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Dr. Margueritte, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997809
- Sponsor's protocol ID
- 87RI23_0049 (ENDALGO)
- Acronym
- ENDALGO
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery
- ClinicalTrials.gov ID
- NCT06997809
- Acronym / sponsor ID
- ENDALGO / 87RI23_0049 (ENDALGO)
- Conditions
- Endometriosis, Pain
- Keywords
- endometriosis, algologic care, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Surgery without calculation of pain questionnaire scores |
| group with adapted support | Experimental | Other: pathway careThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pathway careGroup 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. | Other | group with adapted support |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Dr. Margueritte principal investigator
University Hospital, Limoges
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pathway care in people with Endometriosis, Pain, run by University Hospital, Limoges at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safirah AKOWANOU (+33555058755, safirah.akowanou@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.