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


Phase 3
16 Years
80 Years
Not Enrolling
Female
Breast Cancer, Modified Radical Mastectomy

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Trial Information

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


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.


Inclusion Criteria:



- Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

- Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Duration of drains (days)

Outcome Description:

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.

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Shaista M Khan, FRCS

Investigator Role:

Study Chair

Investigator Affiliation:

Aga Khan University

Authority:

Pakistan: Aga Khan University

Study ID:

1519-Sur-ERC-10

NCT ID:

NCT01587248

Start Date:

March 2010

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • Modified Radical Mastectomy
  • Breast cancer,
  • Harmonic scalpel,
  • Electrocautery,
  • Modified Radical Mastectomy,
  • Randomized Controlled Trial
  • Breast Neoplasms

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