Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study

Conditions
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Deep Endometriosis, Recto Vaginal Node

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endometriosis recto vaginal node<br> | Drug: Indocyanine green<br>* Use of Indocyanine Green during Rectal shaving by laparoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis