FloSeal in CRS and HIPEC

Study Overview
=================
Brief Summary
-----------------
Introduction Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC. To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured. Hypothesis FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure. Primary objective To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC. Secondary objectives To evaluate if the use of FloSeal can reduce operative blood loss. To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure. To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related). To evaluate if the use of FloSeal can have an impact on length of hospital stay.

Official Title
-----------------
Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?

Conditions
-----------------
Peritoneal Carcinomatosis

Intervention / Treatment
-----------------
* Other: FloSeal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients older than 18 year old All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.) Exclusion Criteria: Prophylactic HIPEC Peritoneal Carcinomatosis Index (PCI) < 5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FloSeal +<br>Routine use of Floseal during cytoreductive and HIPEC surgery | Other: FloSeal<br> <br> * Other names: gelatin matrix thrombin solution (Baxter);|
| FloSeal -<br>FloSeal not used during CRS and HIPEC procedure | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate for intra-abdominal bleeding after CRS and HIPEC |  | postoperative day O to hospital discharge (an expected average of 3 weeks after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative blood loss |  | Cytoreductive and HIPEC surgery | 
| Blood products use | packed red blood cells, fresh frozen plasma, platelets, specific coagulation factors and cryoprecipitates | during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks) | 
| Hemoglobin rate |  | at hospital discharge (an expected average of 3 weeks) | 
| Non-hemorrhagic complications | According to the Dindo-Clavien postoperative complications classification | postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery) | 
| Length of hospital stay | Hospital discharge is defined in our study as medical discharge | postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery) |