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The goal of this clinical trial was to compare two surgical techniques-ultrasonic dissector and electrocautery-for performing axillary dissection in women undergoing modified radical mastectomy (MRM) for breast cancer. The study aimed to determine whether using an ultrasonic dissector reduces operation time, the number of days surgical drains remain in place, and the frequency of seroma formation compared to conventional electrocautery.
The main questions the study aims to answer are:
Researchers randomly (1:1) assigned 138 women with breast cancer (aged 35-65 years) undergoing MRM to either the ultrasonic dissector group or the electrocautery group. All surgeries were performed by experienced consultant surgeons using standardized protocols.
Participants:
Outcomes were measured by recording the operation time, the number of days drains remained in place, and the occurrence of seroma. The results would help guide surgical practice by identifying the safer and more efficient dissection method during MRM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery Dissection Group | Active Comparator | Axillary dissection was performed as per standard hospital protocol. |
|
| Ultrasonic Dissection Group | Experimental | Axillary dissection was performed using ultrasonic dissector. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocautery | Device | Axillary dissection was done through bipolar electrocautery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroma Formation | Presence of fluid collection beneath the skin flaps after the removal of the drains of sufficient quantity to cause the patient discomfort and was measured by subcutaneous aspiration & through ultrasonography during the postoperative follow up | 30 days postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgery Time | Duration (minutes) of surgery was noted from skin incision to skin closure using stopwatch. | Intraoperative |
| Drains Duration | Time in days from placement to removal of drain will be calculated. The drains will be removed when the drainage volume is less than 30 ml over 24 h for 2 successive days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tariq I Professor, FCPS | Quaid-e-Azam Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quaid-e-Azam Medical College | Bahawalpur | Punjab Province | 63100 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31964119 | Background | Lee D, Jung BK, Roh TS, Kim YS. Ultrasonic dissection versus electrocautery for immediate prosthetic breast reconstruction. Arch Plast Surg. 2020 Jan;47(1):20-25. doi: 10.5999/aps.2019.00759. Epub 2020 Jan 15. | |
| 33679225 | Background | Deori A, Gupta N, Gupta AK, Yelamanchi R, Agrawal H, Durga CK. A Prospective Randomised Controlled Study Comparing Ultrasonic Dissector with Electrocautery for Axillary Dissection in Patients of Carcinoma Breast. Malays J Med Sci. 2021 Feb;28(1):97-104. doi: 10.21315/mjms2021.28.1.12. Epub 2021 Feb 24. |
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| Ultrasonic dissector | Device | Axillary dissection was done through ultrasonic dissector. |
|
| 30 days postoperatively |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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