Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01957852
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2013-05-21
Brief Title:
FloSeal in CRS and HIPEC
Sponsor:
Maisonneuve-Rosemont Hospital
Organization:
Maisonneuve-Rosemont Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None