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NCT05168839RecruitingPhase 4

FLUOCOL-1 : Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Jan 2026

Brief summary (registry, in English)

To demonstrate that the assessment of anastomotic perfusion using intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) will reduce AL in left-sided or high anterior resection with intraperitoneal anastomosis.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1010 (estimated)
First submitted
19 Aug 2024
Start date
10 Sept 2024
Lead sponsor
Centre Hospitalier Regional Universitaire
NCT number
NCT05168839
EU CT number
2024-515118-42-00
EudraCT number
2021-004814-21

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1010
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergent surgery
  • Associated concomitant resection of other organ (liver, etc.)
  • Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer

Other illness

  • Inflammatory bowel disease
  • History of known allergy to indocyanine
  • Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion
  • Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)
  • Colon cancer requiring transverse colectomy
  • Recurrent colorectal cancer
  • Locally advanced colorectal cancer requiring multi-visceral excision
  • History of colectomy

Other

  • Pregnant patients
  • Refusal to participate or inability to provide informed consent
  • Protected adults (individuals under guardianship by court order).

Who the study is looking for

  • Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
  • Signed informed consent
  • Affiliated to the French social security system (CMU included).
  • Adult patients (age >18 years)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens Picardie
Coordinator of this site? Confirm its status
Amiens Cedex 1FranceRecruiting
CHU Besancon
Coordinator of this site? Confirm its status
Besancon CedexFranceRecruiting
Clinique Tivoli-Ducos
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Hospitalier William Morey
Coordinator of this site? Confirm its status
Chalon Sur Saone CedexFranceRecruiting
Centre Hospitalier Universitaire de Dijon
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Centr Georges Francois Leclerc
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DijonFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
Coordinator of this site? Confirm its status
Grenoble Cedex 9FranceRecruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceRecruiting
Centre Oscar Lambret
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LilleFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Clinique de La Sauvegarde
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LyonFranceRecruiting
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Hopital Europeen Marseille
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MarseilleFranceRecruiting
Hôpital Saint Joseph
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MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Hôpital NOVO
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PontoiseFranceRecruiting
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceRecruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceRecruiting
Sante Atlantique
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St HerblainFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.