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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2019

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.

Interventions

  • Drug: Indocyanine green
    • Use of Indocyanine Green during Rectal shaving by laparoscopy.

Arms, Groups and Cohorts

  • Experimental: endometriosis recto vaginal node

Clinical Trial Outcome Measures

Primary Measures

  • Per-operative evaluation of the rectum
    • Time Frame: at day 1
    • 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

Secondary Measures

  • Side effects after indocyanine green injection
    • Time Frame: at day 1
  • Post operative complications
    • Time Frame: at day 1
    • infections, abdominal abscess, abdominal hematoma, post operative fistula.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • Laboratoire SERB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas BOURDEL, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr

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