Breast Cancer, Modified Radical Mastectomy
Conditions
Keywords
Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHarmonic
Dissection with harmonic scalpel
PROCEDUREelectrocautery
Dissection in modified radical mastectomy
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult females with biopsy proven breast cancer underwent MRM
Exclusion criteria
* Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of drains (days) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 3-4 hours | Time taken in minutes from incision to skin closure |
| Drain Volume | 30 days | 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 | 30 days | 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 | 24 hours | Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours |
Countries
Pakistan
Outcome results
None listed