Use of Harmonic in Breast Surgery

Aga Khan University152 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

152

Conditions

Breast Cancer Modified Radical Mastectomy

Interventions

HarmonicDEVICE

Dissection with harmonic scalpel

electrocauteryPROCEDURE

Dissection in modified radical mastectomy

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult females with biopsy proven breast cancer underwent MRM Exclusion Criteria: * Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Locations (1)

Aga Khan University

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Duration of drains (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.

Time frame: 30 days

Secondary Outcomes

Operative time

Time taken in minutes from incision to skin closure

Time frame: 3-4 hours

Drain Volume

Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.

Time frame: 30 days

Overall complications

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.

Time frame: 30 days

Pain

Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours

Time frame: 24 hours

Data from ClinicalTrials.gov

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