Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03167944 |
Date of registration:
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23/05/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
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Scientific title:
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"Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial" |
Date of first enrolment:
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March 15, 2017 |
Target sample size:
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60 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03167944 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Piratthima Vachiraprakarnsakul |
Address:
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Telephone:
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+66830693791 |
Email:
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Affiliation:
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Name:
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Piratthima Vachiraprakarnsakul |
Address:
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Telephone:
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+66830693791 |
Email:
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piratthima.v@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female aged >18 years old
- Patients that fulfill the indication of mastectomy
- Medium-sized breast volume (Breast weight < 1500 grams)
Exclusion Criteria:
- Patients who cannot complete the informed consent
- Patients with ASA CLASS > 3
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Seroma
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Intervention(s)
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Device: Low thermal electrosurgery system
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Device: Conventional Electrocautery
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Primary Outcome(s)
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Drainage volume after surgery
[Time Frame: Up to 24 weeks]
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Secondary Outcome(s)
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Post operative Pain
[Time Frame: Up to 24 weeks]
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Patient's Hospital costs
[Time Frame: up to 1 week]
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Wound infection
[Time Frame: Up to 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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