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Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

NCT04712032 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 978

Last updated 2021-01-15

No results posted yet for this study

Summary

Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.

Conditions

  • Colo-rectal Cancer
  • Crohn Disease
  • Resectable Colorectal Carcinoma

Interventions

DRUG

ICG-guided bowel perfusion assessment

ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Sponsors & Collaborators

  • Medical Center Haaglanden

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Haga Hospital

    collaborator OTHER

  • Jeroen Bosch Ziekenhuis

    collaborator OTHER

  • Amphia Hospital

    collaborator OTHER

  • Alrijne Hospital

    collaborator OTHER

  • IJsselland

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Alexander Vahrmeijer, MD, PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-07-01
Completion
2022-10-01

Countries

  • Netherlands

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 NCT04712032 on ClinicalTrials.gov