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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002773-35 | Other Identifier | 2016-002773-35 |
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| Name | Class |
|---|---|
| Laboratoire SERB | UNKNOWN |
| Association GEGO | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometriosis recto vaginal node | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Use of Indocyanine Green during Rectal shaving by laparoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects after indocyanine green injection | at day 1 | |
| Post operative complications | infections, abdominal abscess, abdominal hematoma, post operative fistula. | at day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 0473751195 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas BOURDEL | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32646588 | Derived | Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7. | |
| 29885885 | Derived |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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open
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| Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6. |