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Practices in surgery have evolved and the study has not interest yet
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group COSEAL | Experimental |
| |
| Reference group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatic surgery of resection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| LIVER RELEASE VALUE | DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER | 3 years |
| LOSS OF BLOOD | 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno HEYD, PU-PH | CHU Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | France | 25030 | France |
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| hepatic surgery of resection | Procedure | this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group |
|
| CoSeal tolerance |
| 3 years |
| per operative complication | 3 years |
| post operative complication | 3 years |
| hospitalisation time | 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 | 3 years |
| de novo hepatic adherence extension | 0 : no extension of hepatic adherence
| 3 years |
| hepatic adherence reformation | 3 years |
| adherence composite score | this is a mathematic score in relation with area and severity of liver adherence | 3 years |
| composite score and surgery difficulty | this is a correlation between the composite score, the morbidity criteria and dissection difficulty | 3 years |
| liver adherence score validation | 3 years |