Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

Not Applicable

• Conditions: Seroma
• Interventions: Device: Conventional Electrocautery; Device: Low thermal electrosurgery system

• Registration Number: NCT03167944
• Lead Sponsor: Mahidol University

Brief Summary

Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-15
• Status Verified: 2017-05
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30
• Primary Completion: 2018-03-25
• Study Completion: 2018-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female aged >18 years old
• Patients that fulfill the indication of mastectomy
• Medium-sized breast volume (Breast weight < 1500 grams)

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Exclusion Criteria

• Patients who cannot complete the informed consent
• Patients with ASA CLASS > 3

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional electrocautery	Conventional Electrocautery	-
Low thermal electrosurgery system	Low thermal electrosurgery system	-

Primary Outcome Measures

Name	Time	Method
Drainage volume after surgery	Up to 24 weeks	Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration

Secondary Outcome Measures

Name	Time	Method
Wound infection	Up to 24 weeks	Wound infection after surgery
Post operative Pain	Up to 24 weeks	Post-operative Pain measured using 0-10 Numeric pain scale
Patient's Hospital costs	up to 1 week	Expenses that the patient has to pay while staying in the hospital

Trial Locations

Locations (1)

Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand