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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FloSeal + | Routine use of Floseal during cytoreductive and HIPEC surgery |
| |
| FloSeal - | FloSeal not used during CRS and HIPEC procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloSeal | Other |
|
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with peritoneal carcinomatosis (PC) of any cause followed at Hôpital Maisonneuve-Rosemont and undergoing Cytoreductive and HIPEC surgery
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Dubé | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T2M4 | Canada |
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| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C411004 | FloSeal Matrix |
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| 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) |
| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |