FloSeal in CRS and HIPEC

NCT01957852 | Completed

• 1 other identifier: 13019
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• operative blood loss

  Cytoreductive and HIPEC surgery

• Blood products use

  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

  postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)

• Length of hospital stay

  postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)

Study Arms (2)

FloSeal +

Routine use of Floseal during cytoreductive and HIPEC surgery

Other: FloSeal

FloSeal -

FloSeal not used during CRS and HIPEC procedure

Interventions

FloSeal OTHER

Also known as: gelatin matrix thrombin solution (Baxter)

FloSeal +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male and female patients older than 18 year old
• All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)

You may not qualify if:

• Prophylactic HIPEC
• Peritoneal Carcinomatosis Index (PCI) \< 5

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

FloSeal Matrix

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Pierre Dubé

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical oncologist

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: October 8, 2013
• Study Start: January 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 25, 2015

Record last verified: 2015-02

Locations

CA (1)