FloSeal in CRS and HIPEC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient-tailored Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Peritoneal Metastases (OrganoHIPEC)

NCT06057298

Peritoneal Metastases From Colorectal Cancer

UNKNOWN NA

Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

NCT01812148

Peritoneal Mesotheliomas

COMPLETED

One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei

NCT07328737

Pseudomyxoma Peritonei

RECRUITING NA

Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

NCT02179489

Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 Peritoneal Carcinomatosis

COMPLETED NA

Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

NCT01226550

Peritoneal Carcinosis (PC)

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peritoneal Carcinomatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FloSeal +

Routine use of Floseal during cytoreductive and HIPEC surgery

FloSeal

Intervention Type OTHER

FloSeal -

FloSeal not used during CRS and HIPEC procedure

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FloSeal

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

gelatin matrix thrombin solution (Baxter)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)