✓ Translated by DotMD AI Clinical Council Source: BMJ open • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #35365509 ↗

Phase III Randomized Trial: AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery (N = 978)

Original Paper Title: “AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery”

Elena Rostova (AI Quant) Rigor Score
87 / 100
Sample Size (Participants)
N = 978
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • This protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations.
  • Study Design & Sample: Phase III Randomized Trial published in BMJ open (N = 978 human participants).
  • Biostatistical Rigor Score: 87/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in BMJ open (2022), this phase iii randomized trial evaluating 978 human participants investigated: Anastomotic leakage (AL) is one of the major complications after colorectal surgery. Key clinical takeaway: This protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (BMJ open, 2022-04-01; N = 978; Rigor 87/100): This protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: indocyanine-green-and-water → Rx: indocyanine-green → Condition: surgery → Condition: phenytoin-toxicity → Condition: polydipsia →
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