Deep Endometriosis Clinical Trial
— INDIEOfficial title:
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 28, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Association GEGO, Laboratoire SERB |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Per-operative evaluation of the rectum | 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 | at day 1 | |
Secondary | Side effects after indocyanine green injection | at day 1 | ||
Secondary | Post operative complications | infections, abdominal abscess, abdominal hematoma, post operative fistula. | at day 1 |
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