Deep Endometriosis, Recto Vaginal Node
Conditions
Keywords
Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis
Brief summary
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.
Detailed description
Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located. If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar. To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4. After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
Interventions
DRUGIndocyanine green
Use of Indocyanine Green during Rectal shaving by laparoscopy.
Sponsors
Laboratoire SERB
Association GEGO
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* minors patients * Patients under guardianship or wardship * Patients who refused the participation * Iodine allergy * Pregnant woman * Patients during lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per-operative evaluation of the rectum | at day 1 | Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects after indocyanine green injection | at day 1 | — |
| Post operative complications | at day 1 | infections, abdominal abscess, abdominal hematoma, post operative fistula. |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed