FloSeal in CRS and HIPEC

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Carcinomatosis
• Intervention / Treatment: Other: FloSeal

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T2M4
      • Hopital Maisonneuve-Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FloSeal +; Routine use of Floseal during cytoreductive and HIPEC surgery	Other: FloSeal; Other Names: gelatin matrix thrombin solution (Baxter)
FloSeal -; FloSeal not used during CRS and HIPEC procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
operative blood loss		Cytoreductive and HIPEC surgery
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)
Hemoglobin rate		at hospital discharge (an expected average of 3 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Pierre Dubé, Hopital Maisonneuve-Rosemont

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 13019