Informations générales (source: ClinicalTrials.gov)
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study (INDIE)
Interventional
Phase 4
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
août 2017
février 2019
29 juin 2024
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation
of tissue perfusion.
After intravenous injection of indocyanine green, using a near infrared light, the
vascularisation becomes fluorescent.
In endometriosis disease, the treatment of recto vaginal node can be complicated by
rectovaginal fistula.
An abnormal vascularisation related to the surgery would be a risk factor of post
operative fistulas.
The aim of this study is to evaluate the rectal and vaginal vascularisation during the
treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine
green fluorescence.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Patients above the age of 18 year
- Patients with endometriosis recto vaginal node
- Patients with operative indications of rectal shaving, with or without vaginal
resection
- Patients who have accepted to participate
- Patients above the age of 18 year
- Patients with endometriosis recto vaginal node
- Patients with operative indications of rectal shaving, with or without vaginal
resection
- Patients who have accepted to participate
- minors patients
- Patients under guardianship or wardship
- Patients who refused the participation
- Iodine allergy
- Pregnant woman
- Patients during lactation