Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: a Prospective Observational Validation Study of the Dutch Leakage Score, Serum Procalcitonin and Serum CRP: the Italian ColoRectal Anastomotic Leakage (iCRAL) Study Group.
Conditions: Anastomotic Leak, Colorectal Surgery
Sponsor: Ospedale C & G Mazzoni

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". )*"-++*%*	
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 - + %-/$  * $  $   -! % *" %  *
*$
:      * 1  &  %  * $
$$* 3$%$-**
3$%+ $*%* $$
	)3$% *%*""3!"%*"**
 "  *$%$$
$2)*3!-+$&%"%?
 ""-+$% &*%!"
&  +& &3$$"*%&
-+$$&	
7 *" *&
+ )*%3  - + $  $* 1: =.23 *!" % &
$&3 * - +    *"*  $ +- *%
"3 "$$"
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-*$"%,:%%&-+ $"
*$+%%"C-/1-"%*"&%
2-*/$ :/H*&:%@AB3	
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2-*/$ :/H*&I*& 
&-+$% !%%!" $)*
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/$" * 1
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"%%.$K0:&-+$% "" 
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 *'3035(3 %*;
% *
",0'(9 "%%* %*;
0J
 .  ,3*, $LM31+550
.$4/444443$&2

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A$
 !N	3B ?3:8>3"/ $$
 !"6$$&%0%/ *
"96
 B"* )3*>	 !6!%3"3 N
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 >& ?3:*)3;)3 !% 6O
*&*!"9060/5
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%$$.6*B$$"&&
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 @L3@H3I&3>
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  % !%""&IN"95560
5 -H43	*BH3>NH3	*	H
!%% !"%-
-* . N"96
 $!:3I43&I
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"""&	@96
 8"<373	8<3$"3:3?"83I83Q$<
3   & + ! %    !3% *
&%"&N		9605/
 ;"/@+3
737&;3O*3:@3	*=3	*&?37N3

  	/ $   & $ % $  $ % 
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 ;+*% @3 N N3 R :3 
R QR 43 
 #! < 	 $ % 	/
$  $  $ % $$ %  $ %
"&	:N906/
  @! :3 ? 3 >! =
3 I- :3   < 	>3 ;+! 
N3
:83$H>3<	N4 $" % 
!"%"&=N";906/
0 @@3@ ?3		%%" $-$$
-*    * %  $   %  &  " 9
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3+&
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3*&3
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8$<%*:? */% 1:?/726$
%%%N?>*""91265
5 !$$37":3)* $B3	<>3N?"6
&%*N=?N=?96/5
 > )	3 8& 
3 : HN3 N H
3 =  )8 	@	 % %  
"%6 %%	@	%%"-%
4%	>$=$ 965
 	* >B3 - H3 > NH	 !" %   $   %
 "&6&%!%@	
 96/0

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$$.DULK SCORE [14] 
Valori Normali 
Score 
Valori alterati 
Score 
Febbre 
 38.0° C 
0 
 38.0° C 
1 
Frequenza cardiaca 
 100 bpm 
0 
 100 bpm 
1 
Frequenza respiratoria 
 30 atti/min 
0 
 30 atti/min 
1 
Diuresi 
 30 ml/h o 700 ml/die 
0 
 30 ml/h o 700 ml/die 
1 
Stato mentale 
Normale stato mentale 
0 
Agitazione o Letargia 
2 
Condizioni cliniche 
Stabili o in miglioramento 
0 
Deterioramento 
2 
Segni di ileo 
No 
0 
Ileo 
2 
Ritenzione gastrica 
No 
0 
Ritenzione Gastrica 
2 
Deiscenza della fascia 
No 
0 
Deiscenza della fascia 
2 
Dolore addominale o 
altri non di ferita 
No dolore 
0 
Dolore non della ferita 
2 
Segni di infezione 
No aumento leucociti o 
PCR 
0 
Aumento dei leucociti 
di  5% o della PCR 
1 
Funzionalità renale 
No aumento Urea o 
Creatinina 
0 
Aumento di Urea o 
Creatinina di  5%  
1 
Stato nutrizionale 
Dieta Normale 
0 
Enterale/Parenterale 
Totale  
1/2 
TOTALE 
 
 
 
 

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Appendix 2 CLAVIEN-DINDO CLASSIFICATION [15, 16] 
+ $3#	%%"	 $
Grade Definition 
Grade I 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, electrolytes, and 
physiotherapy. This grade also includes wound infections opened at the bedside 
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications 
Blood transfusions and total parenteral nutrition are also included 
Grade III Requiring surgical, endoscopic or radiological intervention 
Grade IIIa Intervention not under general anesthesia 
Grade IIIb Intervention under general anesthesia 
Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU management 
Grade IVa Single organ dysfunction (including dialysis) 
Grade IVb Multiorgan dysfunction 
Grade V Death of a patient 
Suffix “d” If the patient suffers from a complication at the time of discharge (see examples in Table 2), 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. 
*Brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient ischemic attacks. 
CNS, central nervous system; IC, intermediate care; ICU, intensive care unit. 
+ $4#	=. $%	 $8
Grades   
Organ System  
Examples 
Grade I   
Cardiac   
Atrial fibrillation converting after correction of KT-level 
Respiratory  
Atelectasis requiring physiotherapy 
Neurological  
Transient confusion not requiring therapy 
Gastrointestinal  
Noninfectious diarrhea 
Renal  
 
Transient elevation of serum creatinine 
Other  
 
Wound infection treated by opening of the wound at the bedside 
Grade II   
Cardiac   
Tachyarrhythmia requiring T-receptor antagonists for heart rate control 
Respiratory  
Pneumonia treated with antibiotics on the ward 
Neurological  
TIA requiring treatment with anticoagulants 
Gastrointestinal  
Infectious diarrhea requiring antibiotics 
Renal  
 
Urinary tract infection requiring antibiotics 
Other  
 
Same for I followed by tx with antibiotics for phlegmonous infection 
Grade IIIa  
Cardiac   
Bradyarrhythmia requiring pacemaker implantation in local anesthesia 
Neurological  
See grade IV 
Gastrointestinal  
Biloma after liver resection requiring percutaneous drainage 
Renal  
 
Stenosis of the ureter after kidney transplantation treated by stenting 
Other  
 
Closure of dehiscent noninfected wound in the OR under local anesthesia 
Grade IIIb  
Cardiac   
Cardiac temponade after thoracic surgery requiring fenestration 
Respiratory  
Bronchopleural fistulas after thoracic surgery requiring surgical closure 
Neurological  
See grade IV 
Gastrointestinal  
Anastomotic leakage after descendorectostomy requiring relaparotomy 
Renal  
 
Stenosis of the ureter after kidney transplantation treated by surgery 
Other  
 
Wound infection leading to eventration of small bowel 
Grade IVa  
Cardiac Heart failure leading to low-output syndrome 
Respiratory  
Lung failure requiring intubation 
Neurological  
Ischemic stroke/brain hemorrhage 
Gastrointestinal  
Necrotizing pancreatitis 
Renal  
 
Renal insufficiency requiring dialysis 
Grade IVb  
Cardiac   
Same as for IVa but in combination with renal failure 
Respiratory  
Same as for IVa but in combination with renal failure 
Gastrointestinal  
Same as for IVa but in combination with hemodynamic instability 
Neurological  
Ischemic stroke/brain hemorrhage with respiratory failure 
Renal  
 
Same as for IVa but in combination with hemodynamic instability 
Suffix “d” Cardiac Cardiac insufficiency after myocardial infarction (IVa–d) 
Respiratory Dyspnea after pneumonectomy for severe bleeding after chest tube placement (IIIb–d) 
Gastrointestinal Residual fecal incontinence after abscess following descendorectostomy with surgical evacuation. (IIIb–d) 
Neurological Stroke with sensorimotor hemisyndrome (IVa–d) 
Renal Residual renal insufficiency after sepsis with multiorgan dysfunction (IVb–d) 
Other Hoarseness after thyroid surgery (I–d) 
TIA, transient ischemic attack; OR, operating room.

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Screening 
A Presenta una perdita dell’ appetito? Ha mangiato meno negli ultimi 3 mesi? (perdita d’appetito, 
problemi digestivi, difficoltà di masticazione o deglutizione) 
0 = Grave riduzione dell’assunzione di cibo  
1 = Moderata riduzione dell’assunzione di cibo  
2 = Nessuna riduzione dell’assunzione di cibo  
B Perdita di peso recente (<3 mesi) 
0 = perdita di peso > 3 kg  
1 = non sa  
2 = perdita di peso tra 1 e 3 kg  
3 = nessuna perdita di peso  
C Motricità 
0 = dal letto alla poltrona  
1 = autonomo a domicilio  
2 = esce di casa  
D Nell’ arco degli ultimi 3 mesi: malattie acute o stress psicologici? 
0 = sì 2 = no  
E Problemi neuropsicologici 
0 = demenza o depressione grave  
1 = demenza moderata  
2 = nessun problema psicologico  
F1 Indice di massa corporea (IMC) = peso in kg / (alt ezza in m)
2 
0 = IMC <19  
1 = 19  IMC < 21  
2 = 21  IMC < 23  
3 = IMC  23  
SE L’ IMC NON E DISPONIBILE, SOSTITUIRE LA DOMANDA F1 CON LA DOMANDA F2.  
NON RISPONDERE ALLA DOMANDA F2 SE LA DOMANDA F1 E GIA’ STATA COMPLETATA
F2 Circonferenza del polpaccio (CP in cm) 
0 = CP inferiore a 31  
3 = CP 31 o superiore  
Valutazione di screening (max.14 punti)  
12-14 punti: stato nutrizionale normale  
8-11 punti: a rischio di malnutrizione  
0-7 punti: malnutrito  
.  
Ref. Vellas B, Villars H, Abellan G, et al. Overview of the MNA
® - Its History and Challenges. J Nutr Health Aging 2006;10:456-465.  
Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B. Screening for Undernutrition in Geriatric Practice: Developing the Short-Form Mini 
Nutritional Assessment (MNA-SF). J. Geront 2001;56A: M366-377.  
Guigoz Y. The Mini-Nutritional Assessment (MNA
®) Review of the Literature - What does it tell us? J Nutr Health Aging 2006; 10:466-487.  
Kaiser MJ, Bauer JM, Ramsch C, et al. Validation of the Mini Nutritional Assessment Short-Form (MNA®-SF): A practical tool for identification 
of nutritional status. J Nutr Health Aging 2009; 13:782-788.  
® Société des Produits Nestlé, S.A., Vevey, Switzerland, Trademark Owners  
© Nestlé, 1994, Revision 2009. N67200 12/99 10M  
Per maggiori informazioni: www.mna-elderly.com

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