Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.
this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
CHU Besançon
Besançon, France, France
HEPATIC ADHERENCE SEVERITY
Measure of hepatic adherence : SCORE 0: NO HEPATIC ADHERENCE SCORE 1: SHADOW ON HEPATIC ADHERENCE SCORE 2: VASCULAR OR DENSE HEPATIC ADHERENCE SCORE 3:COHESIVE HEPATIC ADHERENCE SCORE 4: DISSECTION IN ANOTHER PLAN THIS 5 SCORE WILL BE ANALYSED ON THE 8 SEGMENT AND ON PEDICLE OF LIVER
Time frame: 3 years
LIVER RELEASE VALUE
DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER
Time frame: 3 years
LOSS OF BLOOD
Time frame: 3 years
CoSeal tolerance
Time frame: 3 years
per operative complication
Time frame: 3 years
post operative complication
Time frame: 3 years
hospitalisation time
Time frame: 3 years
operative difficulty
score 0 if there are no difficulty for the release of liver or score 10 if dissection of liver is impossible
Time frame: 3 years
de novo hepatic adherence extension
0 : no extension of hepatic adherence 1. : 1/3 of area affected 2. : between 1/3 and 2/3 of area affected 3. : more than 2/3 of area affected
Time frame: 3 years
hepatic adherence reformation
Time frame: 3 years
adherence composite score
this is a mathematic score in relation with area and severity of liver adherence
Time frame: 3 years
composite score and surgery difficulty
this is a correlation between the composite score, the morbidity criteria and dissection difficulty
Time frame: 3 years
liver adherence score validation
Time frame: 3 years
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