Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

• Conditions: Peritoneal Cancer
• Interventions: Procedure: CRS and HIPEC

• Registration Number: NCT02741167
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Detailed Description

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies. However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy. Among complications infectious complications are the most common. The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy.
• Written informed consent by the participant after information about the research project

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Exclusion Criteria

• No primary or secondary peritoneal surface malignancy
• No CRS and HIPEC
• Pregnancy
• Younger than 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRS and HIPEC	CRS and HIPEC	Patients subjected to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) due to primary or secondary peritoneal malignancy

Primary Outcome Measures

Name	Time	Method
C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)	30 days

Trial Locations

Locations (1)

Division of Visceral Surgery and Transplantation , University Hospital Zurich; 🇨🇭 Zurich, Switzerland