Use of Harmonic in Breast Surgery (HMRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01587248
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Ghulam Murtaza, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Modified Radical Mastectomy Device: Harmonic Procedure: electrocautery Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Electrocautery
Raising of the flaps with electrocautery
Procedure: electrocautery
Dissection in modified radical mastectomy
Experimental: Harmonic
Dissection with harmonic scalpel in modified radical mastectomy
Device: Harmonic
Dissection with harmonic scalpel

Primary Outcome Measures :
  1. Duration of drains (days) [ Time Frame: 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 Outcome Measures :
  1. Operative time [ Time Frame: 3-4 hours ]
    Time taken in minutes from incision to skin closure

  2. Drain Volume [ Time Frame: 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.

  3. Overall complications [ Time Frame: 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.

  4. Pain [ Time Frame: 24 hours ]
    Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

  • Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01587248

Aga Khan University
Karachi, Sind, Pakistan
Sponsors and Collaborators
Aga Khan University
Study Chair: Shaista M Khan, FRCS Aga Khan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ghulam Murtaza, Co Principal Investigator, Aga Khan University Identifier: NCT01587248     History of Changes
Other Study ID Numbers: 1519-Sur-ERC-10
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Ghulam Murtaza, Aga Khan University:
Breast cancer,
Harmonic scalpel,
Modified Radical Mastectomy,
Randomized Controlled Trial