FloSeal in CRS and HIPEC

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Other: FloSeal

• Registration Number: NCT01957852
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-24
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FloSeal +	FloSeal	Routine use of Floseal during cytoreductive and HIPEC surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Hemoglobin rate	at hospital discharge (an expected average of 3 weeks)
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
operative blood loss	Cytoreductive and HIPEC surgery

Trial Locations

Locations (1)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada