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

Phase 4

• Conditions: Deep Endometriosis; Recto Vaginal Node
• Interventions: Drug: Indocyanine green

• Registration Number: NCT03080558
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-15
• Study Start: 2017-08-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endometriosis recto vaginal node	Indocyanine green	-

Primary Outcome Measures

Name	Time	Method
Per-operative evaluation of the rectum	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France