FloSeal in CRS and HIPEC

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957852
• Other study ID #: 13019
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: February 24, 2015
• Start date: January 2008
• Est. completion date: April 2013

Study information

• Verified date: February 2015
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis

Intervention

Other:
• FloSeal

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation rate for intra-abdominal bleeding after CRS and HIPEC		postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)	Yes
Secondary	operative blood loss		Cytoreductive and HIPEC surgery	Yes
Secondary	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)	Yes
Secondary	Hemoglobin rate		at hospital discharge (an expected average of 3 weeks)	Yes
Secondary	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)	Yes
Secondary	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)	Yes