Inflammatory Markers for Postoperative Complications in C... | NCT03218449

Studies
Inflammatory Markers for Postoperative Complications in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

NCT03218449

Sponsor

Gangnam Severance Hospital

Status

Unknown status

Last Update Posted

Jul 14, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2017Actual

Primary Completion Date

Oct 31, 2017Estimated

Completion Date

Nov 30, 2017Estimated

First Submitted Date

Jun 22, 2017

First Submission Date that Met QC Criteria

Jul 12, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/NC		noninfective complication
2/IC		infective complication

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inflammatory markers	Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected using electronic medical record from preoperative day and postoperative days (POD) 0-14.	up to 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis

Exclusion Criteria:

A Patient treated the dexmedetomidine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yon Hee Shim	Gangnam Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam Severance Hospital		Seoul			South Korea