NCT03080558

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Deep Endometriosis
• Recto Vaginal Node

Interventions

Type	Name	Description
DRUG	Indocyanine green	Use of Indocyanine Green during Rectal shaving by laparoscopy.

Timeline

• Start date: 2017-08-06
• Primary completion: 2019-02-28
• Completion: 2019-02-28
• First posted: 2017-03-15
• Last updated: 2019-02-04

Locations

1 site across 1 country: France