ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

Study Overview
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Brief Summary
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There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

Detailed Description
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Lymphorrhea and seroma are the most common complications of mastectomy in patients with breast cancer. Seroma formation increases admission period, follow-up duration, and postoperative discomforts. Repeated aspiration of seroma increases risk of re-admission due to wound infection. Seroma formation after mastectomy occurs in 10% to 85% of cases with mastectomy. Known risk factors according to previous studies are old age(>60 years), high BMI, tumor size, preoperative chemotherapy, surgical extent, and number of retrieved lymph nodes. To reduce postoperative complications including seroma formation, meticulous hemostasis and lymphatic ligation technique are necessary. Procedures using new surgical devices such as bipolar sealing devices have been introduced. Electrosurgical bipolar sealing devices use the body's own collagen and elastin to create a permanent fusion zone through a combination of pressure and energy. Previous studies suggested that surgery using these devices lead to significant decrease of seroma formation, however their advantages are not well established in case of mastectomy for breast cancer. Several studies showed that an advanced sealing system like bipolar energy sealing system can reduce operative time and cost for postoperative management compared to conventional clamp and tie method in non-breast surgery. If electrosurgical bipolar sealing devices are applied during mastectomy, there would be several potential benefits on vessel and lymphatic ligation. Conventional ligation and monopolar cauterization have several weak points including incompletion of ligation and thermal injury during procedures. On the other hand, electrosurgical bipolar sealing devices can provide a combination of pressure and energy simultaneously to minimize thermal injury and create a permanent fusion zone. Previous studies suggested that electrosurgical bipolar sealing devices shortened removal time of drain after axillary lymph node dissection compared with conventional methods. Another study reported benefits on reducing blood loss, drainage amount, and length of hospital stay. Moreover, a recent study also reported that skin sparing mastectomy using electrosurgical bipolar sealing devices can be used in patients with breast cancer. However, there are several limitations in previous studies. There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

Official Title
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A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery

Conditions
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Seroma as Procedural Complication

Intervention / Treatment
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* Device: electrosurgical bipolar sealing devices
* Procedure: conventional suture and tie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years old and over Patients planned to undergo total mastectomy and axillary lymph node dissection Patients planned to undergo total mastectomy and sentinel lymph node biopsy and/or reconstruction Patients planned to undergo partial mastectomy and axillary lymph node dissection Exclusion Criteria: Bilateral breast cancer patients Male breast cancer patients Patients who underwent ipsilateral axillar surgery or axillar radiation therapy Recurrent breast cancer patients Patients who cannot give informed consents such as non-Korean speakers and patients with intellectual disabilities Vulnerable patients such as pregnant women for enrollment Patients without drain catheter Patients with Ductal carcinoma in situ who have not undergone ipsilateral sentinel lymph node biopsy or axillar lymph node dissection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>For the patients in the control group, surgeon dose not use electrosurgical bipolar sealing device at all and use conventional tie and ligation methods during tissue dissection and vessel ligation. interventions: 'conventional suture and tie' | Procedure: conventional suture and tie<br>* the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.<br>|
| Experimental: study group<br>For the patients in the study group, the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible. interventions: electrosurgical bipolar sealing devices | Device: electrosurgical bipolar sealing devices<br>* Electrosurgical bipolar sealing devices use the body's own collagen and elastin to create a permanent fusion zone through a combination of pressure and energy. Previous studies suggested that surgery using these devices lead to significant decrease of seroma formation, however their advantages are not well established in case of mastectomy for breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total drainage volume after surgery: mL | Total amount of drainage until drain tube removal Drain tube removal timing: When drainage volume is under 50mL/day for at least 2 days | Up to 30 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total exact drainage volume | total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal | Up to 30 weeks after surgery | 
| Drainage volume In hospital: mL | Drainage volume In hospital: mL | Up to 30 weeks after surgery | 
| Total operation running time | Total operation running time | Up to 30 weeks after surgery | 
| Complication ratio within a month after surgery | possible pre-defined complications were defined in reference to previous studies | Up to 1 year after surgery | 
| Frequency of seroma aspiration | examination for frequency and total amount of seroma aspiration within a month after surgery. Under 10mL/day, aspiration is stopped | Up to 30 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrosurgical bipolar sealing devices, breast cancer