An interventional study of electrosurgical bipolar sealing devices and conventional suture and tie in Seroma as Procedural Complication, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Severance Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
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
Time frame: Up to 30 weeks after surgery
Total exact drainage volume
total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal
Time frame: Up to 30 weeks after surgery
Drainage volume In hospital: mL
Drainage volume In hospital: mL
Time frame: Up to 30 weeks after surgery
Total operation running time
Total operation running time
Time frame: Up to 30 weeks after surgery
Complication ratio within a month after surgery
possible pre-defined complications were defined in reference to previous studies
Time frame: 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
Time frame: Up to 30 weeks after surgery
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Severance Hospital