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Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.
The population of this study was formed by women aged older than 18 years old, with breast carcinoma (ductal ou lobular) at any stage, form whom modified radical mastectomy is proposed. Patients were excluded if the present blood dyscrasia, collagen diseases, known uncontrolled chronic disease, infections (mammary or axillary, ulcerated tumors and pregnancy. The women were submitted to modified radical mastectomy consecutive allocated in electric scalpel group and the other group with harmonic scalpel.
Electric scalpels were calibrated at 40 watts of cutting and coagulation power and harmonic scalpel with a GEN04 generator calibrated at power levels 3 and 5, using the HP054 handpiece and HF105 curved blade.
Local postoperative complications analysed were seroma, hematoma, skin necrosis and infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric Scalpel Mastectomy | Active Comparator | Radical mastectomy with electric scalpel |
|
| Harmonic scalpel mastectomy | Experimental | Radical Mastectomy with harmonic scalpel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric scalpel | Procedure | Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in operative conditions and first week seroma drainage | Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week | 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in local complication | Number of participants with adverse events as seroma, hematoma, skin necrosis and infection | day 7 and day 14 |
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Women with breast cancer candidate to a radical mastectomy during the year of 2008.
Prospective trial with women stratified consecutive.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmundo C Mauad, MD, PhD | Director from Barretos Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Câncer de Barretos. | Barretos | São Paulo | 14.784.400 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15135481 | Background | Lumachi F, Brandes AA, Burelli P, Basso SM, Iacobone M, Ermani M. Seroma prevention following axillary dissection in patients with breast cancer by using ultrasound scissors: a prospective clinical study. Eur J Surg Oncol. 2004 Jun;30(5):526-30. doi: 10.1016/j.ejso.2004.03.003. | |
| 14964555 | Background | Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Harmonic scalpel | Procedure | Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade |
|
| 20402305 | Background | Kozomara D, Galic G, Brekalo Z, Sutalo N, Kvesic A, Soljic M. A randomised two-way comparison of mastectomy performed using harmonic scalpel or monopolar diathermy. Coll Antropol. 2010 Mar;34 Suppl 1:105-12. |
| 7720886 | Background | Kurtz SB, Frost DB. A comparison of two surgical techniques for performing mastectomy. Eur J Surg Oncol. 1995 Apr;21(2):143-5. doi: 10.1016/s0748-7983(95)90171-x. |
| 12188072 | Background | Deo SV, Shukla NK, Asthana S, Niranjan B, Srinivas G. A comparative study of modified radical mastectomy using harmonic scalpel and electrocautery. Singapore Med J. 2002 May;43(5):226-8. |
| 14659149 | Background | Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic dissection: effect on seroma formation. Breast. 2003 Oct;12(5):338-41. doi: 10.1016/s0960-9776(03)00110-3. |
| 16700855 | Background | Adwani A, Ebbs SR. Ultracision reduces acute blood loss but not seroma formation after mastectomy and axillary dissection: a pilot study. Int J Clin Pract. 2006 May;60(5):562-4. doi: 10.1111/j.1742-1241.2006.00689.x. |
| 3364865 | Background | Miller E, Paull DE, Morrissey K, Cortese A, Nowak E. Scalpel versus electrocautery in modified radical mastectomy. Am Surg. 1988 May;54(5):284-6. |
| 23579255 | Derived | Ribeiro GH, Kerr LM, Haikel RL, Peres SV, Matthes AG, Depieri Michelli RA, Bailao A Jr, Fregnani JH, Vieira RA. Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel. Int J Surg. 2013;11(6):496-500. doi: 10.1016/j.ijsu.2013.03.013. Epub 2013 Apr 8. |