Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,010

Participants

Timeline

Start Date

September 26, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Colorectal Cancer
Interventions
DRUG

FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).

"In the experimental arm (FLUO+), at least one 0.1mg/kg Infracyanine® bolus will be injected intravenously by the anesthesiologist.~The detection of indocyanine green in the proximal colon segment will be done open or intracorporeally using a dedicated infrared camera.~A surgical film describing the injection technique and fluorescence detection will be presented during the study set-up visits.~An additional injection is allowed at the surgeon's discretion if necessary (change of anastomosis site). The time from injection to indocyanine green detection and any adverse events will be recorded."

Trial Locations (32)

13003

RECRUITING

Hôpiatl Européen, Marseille

13005

RECRUITING

Hôpital La Timone, Marseille

13009

NOT_YET_RECRUITING

Institut Paoli Calmettes, Marseille

13015

RECRUITING

Hôpital Nord AP-HM, Marseille

21000

RECRUITING

University Hospital of Dijon, Dijon

25000

RECRUITING

Centre Hospitalier Universitaire de Besançon, Besançon

31400

RECRUITING

CHU de Toulouse, Toulouse

37170

RECRUITING

Centre Hospitalier de Tours, Tours

38302

RECRUITING

Centre Hospitalier Bourgoin-Jallieu, Bourgoin

38700

RECRUITING

Centre Hospitalier Universitaire de Grenoble, La Tronche

44800

RECRUITING

Santé Atlantique, Saint-Herblain

51100

RECRUITING

Hôpital Robert Debré, Reims

59037

RECRUITING

Centre Hospitalier Universitaire de Lille, Lille

67000

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Strasbourg, Strasbourg

69009

RECRUITING

Centre lyonnais de chirurgie digestive, Lyon

69310

RECRUITING

Centre Hospitalier Lyon-Sud, Lyon

75010

RECRUITING

Hôpital Saint Louis, Paris

75012

RECRUITING

Hôpital Saint Antoine, Paris

75014

RECRUITING

Hôpital Cochin, Paris

76000

RECRUITING

Centre Hospitalier Universitaire de Rouen, Rouen

80054

RECRUITING

Centre Hospitalier Universitaire Amiens-Picardie, Amiens

94275

RECRUITING

Hôpital Bicêtre, Paris

94805

RECRUITING

Gustave Roussy, Villejuif

95300

RECRUITING

Centre Hospitalier de Pontoise, Pontoise

Unknown

RECRUITING

CH Annecy, Annecy

RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

Hôpital St Joseph Marseille, Marseille

RECRUITING

CHU de Nancy, Nancy

RECRUITING

Hôpital Européen Georges Pompidou, Paris

RECRUITING

Ch Pontchaillou, Rennes

RECRUITING

Clinique TIVOLI, Toulouse

RECRUITING

Institut cancérologie de Lorraine, Vandœuvre-lès-Nancy

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER