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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-06

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Endometriosis Recto Vaginal Node

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open

Study Groups

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endometriosis recto vaginal node

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

Use of Indocyanine Green during Rectal shaving by laparoscopy.

Interventions

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Indocyanine green

Use of Indocyanine Green during Rectal shaving by laparoscopy.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No