Use of Harmonic in Breast Surgery (HMRM)

April 26, 2012 updated by: Ghulam Murtaza, Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

  • Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 3-4 hours
Time taken in minutes from incision to skin closure
3-4 hours
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.
30 days
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.
30 days
Pain
Time Frame: 24 hours
Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Study Chair: Shaista M Khan, FRCS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1519-Sur-ERC-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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