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Completed

NCT Number: NCT01957852

FloSeal in CRS and HIPEC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FloSeal

Other

Other names: gelatin matrix thrombin solution (Baxter)

Primary outcomes

  1. Reoperation rate for intra-abdominal bleeding after CRS and HIPEC

    Time frame: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)

Secondary outcomes

  1. operative blood loss

    Time frame: Cytoreductive and HIPEC surgery

  2. Blood products use

    Time frame: 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

  3. Hemoglobin rate

    Time frame: at hospital discharge (an expected average of 3 weeks)

  4. Non-hemorrhagic complications

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

    According to the Dindo-Clavien postoperative complications classification

  5. Length of hospital stay

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

    Hospital discharge is defined in our study as medical discharge

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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