Trial | NCT03080558  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Study Started
Aug 06
2017
Primary Completion
Feb 28
2019
Anticipated
Study Completion
Feb 28
2019
Anticipated
Last Update
Feb 04
2019

Drug Indocyanine green

Use of Indocyanine Green during Rectal shaving by laparoscopy.

endometriosis recto vaginal node Experimental

Criteria 

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
No Results Posted