NCT03080558

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

August 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

March 6, 2017

Last Update Submit

February 1, 2019

Conditions

Deep EndometriosisRecto Vaginal Node

Keywords

Indocyanine green fluorescenceRectal vascularisationVaginal vascularisationLaparoscopic surgeryRectal shavingRecto vaginal nodeDeep Endometriosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Side effects after indocyanine green injection

    at day 1

  • Post operative complications

    at day 1

Study Arms (1)

endometriosis recto vaginal node

EXPERIMENTAL
Drug: Indocyanine green

Interventions

Indocyanine greenDRUG

Use of Indocyanine Green during Rectal shaving by laparoscopy.

endometriosis recto vaginal node

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • minors patients
  • Patients under guardianship or wardship
  • Patients who refused the participation
  • Iodine allergy
  • Pregnant woman
  • Patients during lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32646588DERIVED

  • 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.

    PMID: 29885885DERIVED

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nicolas BOURDEL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
open
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 15, 2017

Study Start

August 6, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)