ENDOmetriosis Robotic Assisted Surgery
Recruiting · NCT06445179 · Interventional (participants receive a specific treatment) · Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
View the official record on ClinicalTrials.gov →Interventions studied
Total Laparoscopic HysterectomyUreterolysis
What this trial is about
The purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥ 18 years of age.
- Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications.
- Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract.
- Failure of first- and second-line medical treatment.
- Eligibility for total hysterectomy with complete removal of endometriosis lesions.
- Participants covered by entitled to social security.
- All participants must provide written informed consent before undergoing the surgical procedure.
Exclusion criteria
- Digestive tract involvement.
- Adenomyosis only.
- Contraindications to surgery.
- Participants who are under guardianship, curatorship, or deprivation of liberty.
Where it is running
2 locations listed.
- Hôpital Privé de Provence - Aix-en-Provence, France
- Hôpital Privé le Bois - Lille, France