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

NCT03080558 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-04

No results posted yet for this study

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.

Conditions

  • Deep Endometriosis
  • Recto Vaginal Node

Interventions

DRUG

Indocyanine green

Use of Indocyanine Green during Rectal shaving by laparoscopy.

Sponsors & Collaborators

  • Laboratoire SERB

    collaborator UNKNOWN

  • Association GEGO

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Nicolas BOURDEL · University Hospital, Clermont-Ferrand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-06
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03080558 on ClinicalTrials.gov