"Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mahidol University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Drainage volume after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Conventional electrocautery
Intervention: Conventional Electrocautery (Device)
Low thermal electrosurgery system
Intervention: Low thermal electrosurgery system (Device)
Outcomes
Primary Outcomes
Drainage volume after surgery
Time Frame: Up to 24 weeks
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
Secondary Outcomes
- Wound infection(Up to 24 weeks)
- Post operative Pain(Up to 24 weeks)
- Patient's Hospital costs(up to 1 week)
Investigators
Suebwong Chuthapisth
Asst. Professor
Mahidol University