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

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 4

Conditions: Recto Vaginal Node; Deep Endometriosis

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT03080558

CHU-305

2016-002773-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

endometriosis recto vaginal node

Experimental group

Treatment:

Drug: Indocyanine green