Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

NCT ID: NCT03723187

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2019-07-31

Brief Summary

Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Detailed Description

A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental group

use Normal saline

Group Type: EXPERIMENTAL

normal saline

Intervention Type: OTHER

experimental group use normal saline sealing tube

comparator group

use Heparin

Group Type: ACTIVE_COMPARATOR

normal saline+heparin

Intervention Type: OTHER

normal saline+heparin(Currently, Regular used in hospital)

Interventions

normal saline

experimental group use normal saline sealing tube

Intervention Type: OTHER

normal saline+heparin

normal saline+heparin(Currently, Regular used in hospital)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteer with new Port-A inserted

Exclusion Criteria

• No

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Po-Jen Ko, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Chien-Hung Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CGMH-IRB-104-9029B

Identifier Type: -

Identifier Source: org_study_id