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Use of Harmonic in Breast Surgery (HMRM)

Primary Purpose

Breast Cancer, Modified Radical Mastectomy

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Harmonic
electrocautery
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

  • Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Electrocautery

Harmonic

Arm Description

Raising of the flaps with electrocautery

Dissection with harmonic scalpel in modified radical mastectomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Operative time
Time taken in minutes from incision to skin closure
Drain Volume
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
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
Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours

Full Information

First Posted
April 19, 2012
Last Updated
April 26, 2012
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01587248
Brief Title
Use of Harmonic in Breast Surgery
Acronym
HMRM
Official Title
Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Modified Radical Mastectomy
Keywords
Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrocautery
Arm Type
Active Comparator
Arm Description
Raising of the flaps with electrocautery
Arm Title
Harmonic
Arm Type
Experimental
Arm Description
Dissection with harmonic scalpel in modified radical mastectomy
Intervention Type
Device
Intervention Name(s)
Harmonic
Intervention Description
Dissection with harmonic scalpel
Intervention Type
Procedure
Intervention Name(s)
electrocautery
Intervention Description
Dissection in modified radical mastectomy
Primary Outcome Measure Information:
Title
Duration of drains (days)
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Operative time
Description
Time taken in minutes from incision to skin closure
Time Frame
3-4 hours
Title
Drain Volume
Description
Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.
Time Frame
30 days
Title
Overall complications
Description
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.
Time Frame
30 days
Title
Pain
Description
Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult females with biopsy proven breast cancer underwent MRM Exclusion Criteria: Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaista M Khan, FRCS
Organizational Affiliation
Aga Khan University
Official's Role
Study Chair
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sind
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24232511
Citation
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.
Results Reference
derived

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Use of Harmonic in Breast Surgery

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