Use of Harmonic in Breast Surgery (HMRM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ghulam Murtaza, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01587248
First received: April 19, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Breast Cancer
Modified Radical Mastectomy
Device: Harmonic
Procedure: electrocautery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Duration of drains (days) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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:
  • Operative time [ Time Frame: 3-4 hours ] [ Designated as safety issue: No ]
    Time taken in minutes from incision to skin closure

  • Drain Volume [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours


Enrollment: 152
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

  • Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587248

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

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ghulam Murtaza, Co Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT01587248     History of Changes
Other Study ID Numbers: 1519-Sur-ERC-10
Study First Received: April 19, 2012
Last Updated: April 26, 2012
Health Authority: Pakistan: Aga Khan University

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014