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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery | Active Comparator | Raising of the flaps with electrocautery |
|
| Harmonic | Experimental | Dissection with harmonic scalpel in modified radical mastectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic | Device | Dissection with harmonic scalpel |
| |
| electrocautery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time taken in minutes from incision to skin closure | 3-4 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaista M Khan, FRCS | Aga Khan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24232511 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000073798 | Second Harmonic Generation Microscopy |
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D000073758 | Nonlinear Optical Microscopy |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Procedure |
Dissection in modified radical mastectomy |
|
| 30 days |
| 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. | 30 days |
| Pain | Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours | 24 hours |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |