FloSeal in CRS and HIPEC

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Peritoneal Carcinomatosis

Treatments: Other: FloSeal

Study type: Observational

Funder types: Other

Identifiers

NCT01957852

13019

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

FloSeal +

Description:

Routine use of Floseal during cytoreductive and HIPEC surgery

Treatment:

Other: FloSeal

FloSeal -

Description:

FloSeal not used during CRS and HIPEC procedure