ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery
Condition: Seroma as Procedural Complication
MeSH terms: Seroma
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): electrosurgical bipolar sealing devices; conventional suture and tie
Intervention type(s): Device; Procedure
Intervention description(s): 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.; the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: electrosurgical bipolar sealing devices, breast cancer