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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endometriosis and Pain

NCT03993197

Endometriosis

COMPLETED NA

Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort

NCT03555903

Deep Infiltrating Endometriosis

RECRUITING

Study of the Prevalence of Endometriosis and Adenomyosis

NCT06211569

Elective Fertility Preservation

RECRUITING

Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma

NCT06207448

Endometriosis Ovary

COMPLETED

Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

NCT03779256

Endometriosis Related Pain Quality of Life Pain, Chronic +4 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis, Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Surgery without calculation of pain questionnaire scores

Group Type NO_INTERVENTION

No interventions assigned to this group

group with adapted support

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.

Group Type EXPERIMENTAL

pathway care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No