Use of Harmonic in Breast Surgery (HMRM)
To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.
Modified Radical Mastectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial|
- Duration of drains (days) [ Time Frame: 30 days ] [ Designated as safety issue: No ]Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was <30ml a day.
- Operative time [ Time Frame: 3-4 hours ] [ Designated as safety issue: No ]Time taken in minutes from incision to skin closure
- Drain Volume [ Time Frame: 30 days ] [ Designated as safety issue: No ]Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.
- Overall complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Patients were followed up till 3o days. If any of the following were found, the patient was labelled to have complication:
Seroma- fluctuant swelling under the flaps; SSI- as per CDC criteria; Hematoma- swelling under flaps with characteristic bruising; Flap necrosis- partial or complete necrosis of flaps.
- Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours
|Study Start Date:||March 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Electrocautery
Raising of the flaps with electrocautery
Dissection in modified radical mastectomy
Dissection with harmonic scalpel in modified radical mastectomy
Dissection with harmonic scalpel
In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587248
|Aga Khan University|
|Karachi, Sind, Pakistan|
|Study Chair:||Shaista M Khan, FRCS||Aga Khan University|