Clinical trial NCT01957852: FloSeal in CRS and HIPEC
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 ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Carcinomatosis
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peritoneal carcinomatosis (PC) of any cause followed at Hôpital Maisonneuve-Rosemont and undergoing Cytoreductive and HIPEC surgery

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.


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

Primary outcomes:
measure: Reoperation rate for intra-abdominal bleeding after CRS and HIPEC
timeFrame: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)
Secondary outcomes:
measure: operative blood loss
timeFrame: Cytoreductive and HIPEC surgery
measure: Blood products use
timeFrame: during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks)
measure: Hemoglobin rate
timeFrame: at hospital discharge (an expected average of 3 weeks)
measure: Non-hemorrhagic complications
timeFrame: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
measure: Length of hospital stay
timeFrame: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Pierre Dubé
role: PRINCIPAL_INVESTIGATOR
References: