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

Deep Endometriosis Clinical Trial

— INDIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080558
• Other study ID #: CHU-305
• Secondary ID: 2016-002773-35
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Association GEGO, Laboratoire SERB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects after indocyanine green injection		at day 1
Secondary	Post operative complications	infections, abdominal abscess, abdominal hematoma, post operative fistula.	at day 1