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

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

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.

Study Overview

• Status: Unknown
• Conditions: Deep Endometriosis; Recto Vaginal Node
• Intervention / Treatment: Drug: Indocyanine green

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Nicolas BOURDEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endometriosis recto vaginal node	Drug: Indocyanine green; Use of Indocyanine Green during Rectal shaving by laparoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per-operative evaluation of the rectum	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	at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratoire SERB; Association GEGO
• Investigators: Principal Investigator: Nicolas BOURDEL, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.
• Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2017
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Indocyanine green fluorescence; Rectal vascularisation; Vaginal vascularisation; Rectal shaving; Recto vaginal node; Deep Endometriosis
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Endometriosis; Neovascularization, Pathologic
• Other Study ID Numbers: CHU-305; 2016-002773-35 (Other Identifier: 2016-002773-35)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No