Use of Harmonic in Breast Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial

Conditions
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Breast Cancer, Modified Radical Mastectomy

Intervention / Treatment
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* Device: Harmonic
* Procedure: electrocautery


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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electrocautery<br>Raising of the flaps with electrocautery | Procedure: electrocautery<br>* Dissection in modified radical mastectomy<br>|
| Experimental: Harmonic<br>Dissection with harmonic scalpel in modified radical mastectomy | Device: Harmonic<br>* Dissection with harmonic scalpel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Time taken in minutes from incision to skin closure | 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. | 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. | 30 days | 
| Pain | Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial