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

Deep Endometriosis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis
• Neovascularization, Pathologic
• Recto Vaginal Node

• NCT number: NCT03080558
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin@chu-clermontferrand.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2017
• Completion date: February 28, 2019