Peritoneal Carcinomatosis Clinical Trial
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 ?
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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