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Use of Harmonic in Breast Surgery

NCT ID: NCT01587248

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Modified Radical Mastectomy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Electrocautery

Raising of the flaps with electrocautery

Group Type ACTIVE_COMPARATOR

electrocautery

Intervention Type PROCEDURE

Dissection in modified radical mastectomy

Harmonic

Dissection with harmonic scalpel in modified radical mastectomy

Group Type EXPERIMENTAL

Harmonic

Intervention Type DEVICE

Dissection with harmonic scalpel

Interventions

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Harmonic

Dissection with harmonic scalpel

Intervention Type DEVICE

electrocautery

Dissection in modified radical mastectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria

* Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Ghulam Murtaza

Co Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaista M Khan, FRCS

Role: STUDY_CHAIR

Aga Khan University

Locations

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Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 24232511 (View on PubMed)

Other Identifiers

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1519-Sur-ERC-10

Identifier Type: -

Identifier Source: org_study_id