Standardised Definition of Morbidity in Clinical Trials

Clavien-Dindo Classification

 

Minor Morbidity (Grade 1 according to the Clavien-Dindo classification)

  

Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

 

 

Major morbidity (Grade 2 to 4 according to the Clavien-Dindo classification)

 

Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

 

Grade 3: Requiring surgical, endoscopic or radiological intervention.

 

Grade 3a: Intervention not under general anaesthesia

 

Grade 3b: Intervention under general anaesthesia

 

Grade 4: Life-threatening complication (including CNS complications) requiring Intermediate care/ICU-management

 

Grade 4a: Single organ dysfunction (including dialysis)

 

Grade 4b: Multiple organ dysfunction (including dialysis)

 

Grade 5: Death of a patient

  

  

Notes

 

If more than 1 complications are present the highest grade of complication should be used for statistical purposes

 

 

The total number of complications may be a useful numeric parameter when predicting outcomes

 

 

If the patients suffers from a complication at the time of discharge, the suffix “d” (for ‘disability’) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.

 

 

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