Peritoneal Carcinomatosis
Conditions
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.
Interventions
OTHERFloSeal
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| operative blood loss | Cytoreductive and HIPEC surgery | — |
| Blood products use | during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks) | packed red blood cells, fresh frozen plasma, platelets, specific coagulation factors and cryoprecipitates |
| Hemoglobin rate | at hospital discharge (an expected average of 3 weeks) | — |
| Non-hemorrhagic complications | postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery) | According to the Dindo-Clavien postoperative complications classification |
| Length of hospital stay | postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery) | Hospital discharge is defined in our study as medical discharge |
Countries
Canada
Outcome results
None listed