The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study

Completed

• Conditions: Peritoneal Surface Malignancies
• Interventions: Drug: HIPEC cytoreductive surgery

• Registration Number: NCT02325648
• Lead Sponsor: Yonsei University

Brief Summary

The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-14
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

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Exclusion Criteria

• Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIPEC cytoreductive surgery	HIPEC cytoreductive surgery	-

Primary Outcome Measures

Name	Time	Method
Vital sign	from 30 minutes to 90 minutes after HIPEC
pulmonary vascular permeability index	from 30 minutes to 90 minutes after HIPEC
Body temperature	from 30 minutes to 90 minutes after HIPEC
serum glucose	from 30 minutes to 90 minutes after HIPEC

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, South Korea, Korea, Republic of