|Year : 2017 | Volume
| Issue : 3 | Page : 543-546
Axillary dissection for breast cancer using electrocautery versus ultrasonic dissectors: A prospective randomized study
Subbiah Shanmugam, Gopu Govindasamy, Syed Afroze Hussain, Prasanna Srinivasa H Rao
Department of Surgical Oncology, Government Royapettah Hospital, Kilpauk Medical College, Chennai, Tamil Nadu, India
|Date of Web Publication||24-May-2018|
Dr. Subbiah Shanmugam
Department of Surgical Oncology, Government Royapettah Hospital, Kilpauk Medical College, Chennai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
BACKGROUND: The major morbidities of modified radical mastectomy both short- and long-term are sequelae of axillary dissection. Flap complications, prolonged seroma, need for axillary drainage, wound infection, lymphedema, shoulder stiffness, and paresthesia are major causes for morbidity after axillary dissection. Different techniques have been implemented to tackle these problems. Few of these include reducing the axillary dead space, using various forms of energy devices. AIMS: We have prospectively compared two energy sources, namely, ultrasonic dissector (UD) against the electrocautery dissection in axillary dissection for breast cancer with respect to outcomes. MATERIALS AND METHODS: One hundred female patients with breast cancer undergoing modified radical mastectomy were randomized to either of the two arms – axillary dissection using UD and axillary dissection using electrocautery. The parameters taken into consideration were operating time, operative blood loss, amount and duration of axillary drainage, flap complications, nodal yield, and postoperative pain scoring. RESULTS: There were no significant differences overall between the two groups with respect to oncological safety and functional outcomes.
Keywords: Axillary dissection, breast cancer, electrocautery dissection, harmonic, ultrasonic dissection
|How to cite this article:|
Shanmugam S, Govindasamy G, Hussain SA, Rao PS. Axillary dissection for breast cancer using electrocautery versus ultrasonic dissectors: A prospective randomized study. Indian J Cancer 2017;54:543-6
|How to cite this URL:|
Shanmugam S, Govindasamy G, Hussain SA, Rao PS. Axillary dissection for breast cancer using electrocautery versus ultrasonic dissectors: A prospective randomized study. Indian J Cancer [serial online] 2017 [cited 2019 Dec 6];54:543-6. Available from: http://www.indianjcancer.com/text.asp?2017/54/3/543/233140
| » Introduction|| |
Axillary dissection for breast is the standard approach for achieving regional control in breast cancer. The major morbidities of modified radical mastectomy, both in the short- and long term, are sequel to axillary dissection. Various methods have been proposed and tried in the past to reduce the morbidity of axillary dissection.
Flap complications, prolonged seroma, need for axillary drainage, wound infection, lymphedema, shoulder stiffness, and paresthesia are some of the major causes of morbidity after axillary dissection.
Different techniques have been implemented to tackle these problems such as reducing the axillary dead space and using various forms of energy devices. We have prospectively compared two energy sources, namely, ultrasonic dissector (UD) and the electrocautery (EC), in the axillary dissection for breast cancer.
Aims and objectives
The aim of this study was to compare various intra- and postoperative parameters between the two energy sources. The parameters taken into consideration included operating time, operative blood loss, amount and duration of axillary drainage, flap complications, nodal yield, and postoperative pain scoring.
| » Methodology|| |
One hundred women with breast cancer who were undergoing modified radical mastectomy were randomized to either of the two arms – axillary dissection using UD and axillary dissection using EC. The study was carried out between October 2014 and March 2016. The Institutional Ethics Committee gave approval for the study.
Female patients over the age of 18 years with biopsy-proven breast cancer irrespective of the stage and preoperative therapy who were planned for modified radical mastectomy were included in this study.
Patients undergoing toilet mastectomy, breast conservative surgery, breast reconstruction with flap, or those receiving split skin graft for skin defect, and those with coagulation and rheumatological disorders were excluded from the study. Patients with previous axillary surgery and those who were to undergo sentinel node biopsy were also excluded from the study.
Written consent for the procedure and study was taken from all the participants. Those unwilling to provide consent were excluded from the study. All patients underwent Auchincloss modification of modified radical mastectomy. The skin incision was made using scalpel. Skin flaps were raised using EC. The mastectomy portion of the surgery was completed using EC alone. Once the boundaries of axillary dissection were entered, the energy source usage was guided as per the randomization. The entire axillary dissection was completed solely using either of the modalities – UD or EC. Axillary dissection as a routine involved removal of all nodal and fibro-fatty lymphatic tissue from levels one to three. A single-suction drain was kept in the axilla.
Various intra- and postoperative parameters were recorded [Table 1].
Breast volume was calculated using the water displacement method (using Archimedes principle). All patients received a single dose of prophylactic parenteral antibiotic, postoperative analgesia using nonsteroidal anti-inflammatory drugs, and shoulder physiotherapy on the surgical side.
Postoperatively, the drain was removed after drainage of ≤30 ml on two consecutive days. Drain fluid was quantified on a daily basis till removal. The nature of the fluid was also recorded. Patients were followed up in the postoperative period, wound healing was recorded, seroma if any was aspirated, and lymphedema if any was documented. All patients continued to receive adjuvant therapy based on the definitive histopathology.
Patients' physical characteristics and postoperative histopathology were recorded. Descriptive statistics were reported using mean and standard deviation for continuous normally distributed variables else median and 25th, 75th percentiles. Categorical variables were reported using number and percentages. Continuous variables were compared using Mann–Whitney U-test. P < 0.05 was considered statistically significant.
| » Results|| |
A total of 100 breast patients were randomized into either arm. Of these, 45 patients were in the harmonic arm against 55 in the EC arm. There were no significant differences in age (mean age 52.69 years for UD group against 49 years for EC group; P = 0.13), body mass index (BMI) (BMI of UD was 24.2 and against 23.6 for EC group), and breast volume (breast volume of UD group was 1010 ml against 960.5 ml for EC group) [Table 2].
The total time taken for modified radical mastectomy was 134.8 min in the UD arm as against 101.8 min in the EC arm (P < 0.001). Hence, the average surgery duration in the UD arm was significantly much longer.
The average intraoperative blood loss was lower in the UD arm, although it did not reach statistical significance (189.6 ml vs. 211.4 ml; P = 0.061) [Table 3].
On subgroup analysis, it was found that the amount of drain volume increased with age, breast volume, and BMI of the patients, irrespective of the mode of energy source used for axillary dissection [Table 4].
|Table 4: Subgroup analysis-impact of body mass index and breast volume on seroma volume and number of days to drain removal|
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Of the patients who were taken up for surgery after neoadjuvant chemotherapy, the patients in the UD arm had significantly higher drain volume and longer periods of drain (P value for both parameters was <0.01) [Table 5].
|Table 5: Subgroup analysis-impact of age and chemotherapy on seroma volume and number of days to drain removal|
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| » Discussion|| |
Previous authors have described various strategies to reduce the morbidity of axillary dissection with limited success, including closure of dead space,, use of thrombin, compression dressings, aspiration alone instead of drainage, use of collagen tissue sealants, and delaying postoperative shoulder exercises. Use of ultrasonic shears for breast cancer surgery was described in 2000 by Deo et al., in which they showed the feasibility of modified radical mastectomy using ultrasonic shears. Subsequently, several authors have compared the use of ultrasonic shears and EC for breast cancer surgery. Most of these studies were nonrandomized case series or retrospective reviews. Some prospective studies reported conflicting results regarding the efficacy of ultrasonic shears, although most claimed benefit in some or all the parameters studied.,
The Harmonic Scalpel is an innovative device that vibrates at 55.5 kHz and causes three synergistic effects – cavitation, coagulation, and cutting – to achieve effective hemostasis and tissue dissection at a precise point. With its advantage of reduced thermal spread that lowers the incidence of adjacent tissue destruction, this instrument has been approved by the US Food and Drug Administration for ligation of vessels up to 5 mm in diameter. The safety and advantages of the Harmonic Scalpel have been reported for surgeries in several anatomical regions.,,
UD decreases operation time by decreasing the amount of bleeding without increasing the seroma incidence. High cytokine levels in drainage fluids from patients operated with EC indicate that EC induces more tissue damage and acute inflammatory response. Therefore, seroma, caused by acute inflammatory response, was seen more frequently in the EC group. UD coagulates protein by breaking hydrogen bonds which may close vascular and lymphatic channels more precisely. However, its actual preventive effect on seroma formation might be related to diminished inflammatory response.
Given the significant morbidity of axillary lymph node dissection (ALND) and the costs associated with their management, multiple studies have tried to identify risks factors as well as methods to reduce complications. Risk factors for seroma formation include modified radical mastectomy rather than partial mastectomy, older age, patient weight, BMI, and drainage output at 48 h (>50 cc/day).
The role of axillary drainage has been an area of focus. Drains have been shown to reduce seroma rates compared to no drainage at all., Use of thrombin spray failed to show any significant reduction in seroma formation or days required for closed suction drainage. In a prospective randomized trial by Berger et al., the use of fibrin glue did not prevent or reduce seroma formation, aspiration volume, or complications. Use of argon beam decreased operative blood loss but not seroma formation.
Variations in surgical technique have also been explored. Classe et al. attempted to reduce hospital stay using axillary padding and three-layered closure of the axilla rather than closed suction drainage; here were no differences in postoperative seroma rates (P = 0.9) or needle aspiration (P = 0.94). Wound closure by suturing skin flaps to the axillary space resulted in longer operative times but decreased the number of days until drain removal, as well as the overall drain volume, thereby resulting in reduced rates of seroma formation. He et al. studied 128 women with confirmed T1-3 N1-2 breast cancer and randomly assigned them to undergo mastectomy or breast-conserving surgery with axillary dissection using Harmonic Focus or EC. Using Harmonic Focus significantly diminished operative time, blood loss, total drainage volume, days of stay, and visual analog scale compared to the traditional EC. There was no statistical difference between the two groups regarding seroma, hematoma, and flap necrosis.,
In a study by Kozomara et al., 31 patients were operated using Harmonic Scalpel and 30 using the monopolar EC. The duration of postoperative hospital stay did not differ statistically between the two groups nor the postoperative pain intensity, amount of administered analgesics, number or types of postoperative complications, as well as the time needed for return to everyday activities.
In a study by Suraj et al. (2013), 92 patients were randomized to undergo axillary dissection with either ultrasonic shears (n = 46) or EC (n = 46) There was no statistically significant difference in either primary endpoint of time till drain removal (15 vs. 14.5 days, P = 0.73) or cumulative axillary drainage (1260 vs. 1086.5 ml, P = 0.79). The authors concluded that there is no advantage in using ultrasonic shears instead of cautery in reducing drainage following axillary dissection for breast cancer.
Some authors have addressed the role of obesity in affecting lymphatic function. Garcia et al. concluded that, in animal models, obesity decreases lymphatic function by increasing perilymphatic inflammation. However, few authors including Bohm et al. (2011) found a multivariable independent influence in axillary seroma formation and volume of breast drainage with Harmonic Scalpel. Evident difference in the volume and duration of axillary and breast drainage, subjective and objective postoperative pain, reduction in serum hemoglobin, size and weight of resected breast tissue, and length of hospital stay in favor of the Harmonic instrument was also reported.
Currie et al. included six trials in a meta-analysis of 287 mastectomies. There was no effect in the total postoperative drainage or seroma development. Intraoperative blood was slightly less for ultrasonic dissection compared to standard EC. Ultrasonic dissection and standard EC had similar outcomes with regard to operative time and wound complications.
In our series, the distribution of patient population between the two groups was comparable with respect to BMI, age, and breast volume. The study has proven the noninferiority of UD over EC with respect to technical feasibility, nodal harvest, and functional outcomes.
The time taken for surgery was significantly higher for UD group. There was a trend toward lesser intraoperative blood in the UD arm, but was not statistically significant (189.6 ml vs. 211.4 ml; P = 0.061).
The study further established the relation of increased age, BMI, and breast volume as independent factors affecting the axillary drainage and hence the time to drain removal.
Better lymphatic sealing leads to a lower volume of axillary drainage. In this regard in patients undergoing upfront surgery, the volume of axillary drainage shows a trend toward significance with results in favor of the UD group (972 ml vs. 1134 ml; P = 0.07). At the same time, inability of ultrasonic device in lymphatic sealing among patients undergoing axillary dissection in postchemotherapy context has been clearly demonstrated.
| » Conclusions|| |
The innate characteristics of the lymphatics drainage of the breast need to be better addressed. There are significant differences among patients, depending on their morphological features. The major determinants of axillary drainage and seroma formation after surgery include the body fat distribution, the age of the patient, prior exposure to chemotherapy, and the breast volume. Better matching of these variables is needed for a good comparison. The ability of the energy sources to seal the lymphatic channels is a special area that has not been addressed.
In conclusion, the use of the ultrasonic device is safe in axillary dissection. However, its role in reducing axillary drainage and early drain removal is not superior to EC. However, it may be of use in selected situations, including patients with younger age, lower breast volume, and lower BMI. At the same time, its higher cost should be taken into consideration.
Further research is needed in the mechanism of lymphatic sealing, the effect of the independent variables, namely, age, BMI, and the effect of chemotherapy on axillary drainage.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]