ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-06-27

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.

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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.

Conditions

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Seroma as Procedural Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

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'

Group Type ACTIVE_COMPARATOR

conventional suture and tie

Intervention Type PROCEDURE

the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.

study group

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

Group Type EXPERIMENTAL

electrosurgical bipolar sealing devices

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

conventional suture and tie

the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No