Use of Harmonic in Breast Surgery
HMRM
Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
1 other identifier
interventional
152
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Mar 2010
Shorter than P25 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedApril 30, 2012
April 1, 2012
1.3 years
April 19, 2012
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Operative time
3-4 hours
Drain Volume
30 days
Overall complications
30 days
Pain
24 hours
Study Arms (2)
Electrocautery
ACTIVE COMPARATORRaising of the flaps with electrocautery
Harmonic
EXPERIMENTALDissection with harmonic scalpel in modified radical mastectomy
Interventions
Eligibility Criteria
You may qualify if:
- Adult females with biopsy proven breast cancer underwent MRM
You may not qualify if:
- Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aga Khan University
Karachi, Sindh, Pakistan
Related Publications (1)
Khan S, Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014 Mar;21(3):808-14. doi: 10.1245/s10434-013-3369-8.
PMID: 24232511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shaista M Khan, FRCS
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co Principal Investigator
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 30, 2012
Study Start
March 1, 2010
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
April 30, 2012
Record last verified: 2012-04