INTRODUCTION
Breast reduction is a common procedure performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia. Common problems encountered by patients with macromastia include neck and shoulder strain with grooving from bra straps, headaches, back pain, persistent rashes in the intertrigous areas and heavy anterior chest (1). Breast reduction procedures lead to improvement or elimination of these symptoms. The psychological wellbeing of patients who undergo breast reduction is also positive (2).
The success of a breast reduction operation can to a large extent be judged by the survival of the landmark nipple-areola complex (NAC) of the breast. This depends on a good neurovascular supply to the breast (3,4). Pedicle design in breast reduction surgery follows the neurovascular supply, aiming to ensure at least one reliable source of blood flow to the tissue that is selected for the pedicle (5).
Once the pedicle of choice that is believed would offer the best results for a patient has been chosen, most often the superomedial in our practice, which is also reported to maintain good innervation and sensation (6), it is important that subsequent procedures will ensure preservation of nipple viability and sensation. The first step is the de-epithelialization of the pedicle. Traditionally pedicle de-epithelialization is carried out using a scalpel. This method of de-epithelialization is reliable. However, it is time-consuming and results in bleeding (7). It is for these reasons that some authors have attempted different ways of de-epithelialization with the hope of decreasing operative time and blood loss while maintaining reliability, a good blood supply and preservation of nipple sensation (7).
Various attempts have been made over the years to improve on the time taken to perform pedicle de-epithelialization. Juma et al (1995) used an electric dermatome for pedicle de-epithelialization and showed a reduction of the total operative time by up to 40 minutes (8). Although the method looks appealing and may be faster, it has not gained any popularity in the plastic surgical field. This may be due to the added cost that comes with consumables used with the dermatome machine. In another report Bellioni et al (2006) reported a reduction in operative time by using the brace technique (9). This technique entails constricting the base of the breast using a tourniquet made of an 8 ½ sterile glove then secured with Kocher forceps. One of the basic principles of plastic surgery is to handle tissue in a non-traumatic way and therefore this method goes against that principle. In addition, constricting the base of the breast will constrict the blood supply to the breast, which is not ideal. In 2005, Khan and colleagues advocated for the use of curved scissors for de-epithelialization and reported that this method was rapid (10). Although the method was quicker when compared to previous techniques, it has limitations in that finding the right plane for de-epithelialization can prove challenging. Furthermore, Khan et al. suggested that the use of diathermy has a potential disadvantage of delayed wound healing, seroma formation and that the smoke produced may be a hazard and a nuisance to the surgeon. A similar conclusion was drawn from an earlier study conducted by Demirtas et al (2003) (11). Barr et al (2003) however, showed that the diathermy technique was safe to use and safely decreases blood loss, decreases operative time and was easier than de-epithelialization with a scalpel or scissors (7).
Other authors in case studies have reported the use of the Versajet for de-epithelialization and have noted a decrease in operative time (12). However, similar to the dermatome, the use of the Versajet machine can be costly as the consumables required are very expensive. The ideal pedicle de-epithelialization technique must be safe and rapid with minimal or no complications. A comparison of the two methods is important since both the diathermy technique and the surgical blade method are reported to be safe (7). The conflicting findings of the efficacy of diathermy for pedicle de-epithelialization in breast reduction surgery and the need to improve on the surgical blade technique led to this study.
This study aimed to determine the safety of using diathermy for pedicle de-epithelialization during breast reduction compared to the commonly used surgical blade method at our local institutions. Notably, surgeons in our units tend to avoid diathermy for fear that it will lead to necrosis. By using a within-patient controlled study design, factors that could affect nipple viability and sensation such as the effect of smoking, are mitigated. A novel addition was the fact that this study has also never been conducted on medial pedicle breast reductions.
METHODS
Ethics approval for the study was granted by the University of the Witwatersrand's Human Research Ethics Committee. This study was a prospective randomized, within-patient controlled study of patients who were undergoing breast reduction procedures at the Chris Hani Baragwanath Academic Hospital (CHBAH) and Helen Joseph Hospital (HJH) in the Department of Plastic Surgery Breast Units. A standard and newly introduced procedures should ideally maintain or minimize costs to the patient or health facility. Since diathermy is routinely used during breast reduction procedures, no extra cost was incurred. A power calculation (0.80 power, 0.05 alpha) suggested that a sample size of 13 per group was sufficient, hence, the sample size of 15 patients totaling 30 breasts (15 per group), made a reasonable number to enable statistically significant conclusions. All patients, 18 years and above undergoing bilateral breast reduction, as well as those undergoing breast-conserving therapy for breast cancer (except those with central tumours) were included in the study. Patients undergoing secondary or repeat breast reduction procedures were excluded from the study.
To prevent bias during the study, the six surgeons involved with this study were randomly allocated the method to use for pedicle de-epithelialization. Furthermore, both procedures were performed simultaneously on the same patient and not on different patients to mitigate variations such as increased blood loss from individuals with underlying conditions. A standard monopolar diathermy with a blade electrode tip was used for the diathermy group. The diathermy mode chosen was cutting with the energy level set between 30 and 40 watts. For the surgical blade group, a size 15 blade was used for all cases. The control of the device in each case was at the discretion of the surgeon with the aim of replicating their natural way of using the device under normal conditions.
Duration of Procedure: The timing of the procedures for each breast was determined with the help of the anaesthetist who set different timers for each procedure or breast to minimize errors.
Blood loss. Blood loss was assessed by weighing the swabs that were used during the pedicle de-epithelialization process. Swabs were weighed before and after use (at the end of the procedure since safety was priority) with a standard scientific scale to accurately determine the amount of blood loss. The weight of the swabs was recorded in grams and then converted to milliliters (1 gram = 1 milliliters). A subtraction calculation of the weight before and after procedure equates to the volume of blood loss. The average rate of blood loss was estimated (2.56 mL/minute for the surgical blade and 1.06 mL/minute for diathermy) and a correction factor included in the calculation of blood loss at the same time for both procedures to avoid bias since blood loss was only determined at the end of the procedure. The correction factor was only applied to the surgical blade component while keeping the diathermy values constant. Although the most common method of quantifying blood loss during surgical procedures is by visual inspection of swabs post-use, weighing should provide a more accurate assessment. Anaesthetists within the center also prefer visual assessment. In this study, both methods were used in the analysis for comparison and to improve accuracy.
Nipple viability and sensation: Nipple viability and sensation were assessed and reported as per patients’ response. This was done pre-operatively and one day post the procedure, at one week and one month follow up. Further evaluation of sensation in patients who maintained pre-operative sensation after the procedure was not continued. For the patients who did not have sensation, further evaluation was also carried out at three and six months. Patients were blinded as to which method had been used for either of the breasts. An observation of both nipples and associated bleeding after a needle prick was indicative of viability. The Semmes-Weinstein Monofilament test was used for evaluation of nipple sensation. This is a clinical test that measures response to a touching sensation of the monofilaments using a numerical quantity (13).
Statistical analysis: Data was captured in Microsoft Excel 2016 and imported into STATA Version 16.0 suite of analytics software for statistical analysis. The normality of the data distribution was determined using the Shapiro-Wilk test for continuous variables. Descriptive statistics were performed for all participants and reported as mean ± standard deviation. Median values with interquartile ranges (IQRs) were reported for continuous variables, and frequencies and percentages for categorical variables as appropriate. The Wilcoxon signed-rank test was used as a nonparametric test to determine associations between the groups and a pairwise correlation test was used to determine correlation. A p-value of <0.05 was considered statistically significant.
RESULTS
A total of 15 patients were included in this study totaling 30 breasts (Table 1). Twelve patients had bilateral breast reduction for macromastia, one patient had bilateral breast reduction pattern for excision of breast cancer, and another had a bilateral breast reduction pattern for gynecomastia correction. The last patient had mastopexy for breast ptosis correction. The mean age (±SD) of the patients was 34.0 (±12.8) years (range: 18.0 – 59.0 years). The median (IQR) nipple to notch distance on the diathermy operated breast was 32.5 (29.0-34.0) cm and 32.0 (29.0-34.5) cm on the surgical blade operated breasts (p = 0.08). The median (IQR) weight of tissue resected was 750.0 (465.0-1130.0) g with the surgical blade and 750.0 (469.0-1100.0) g with diathermy (p = 0.55).
Demographic of participants
| Parameter | Patients (n = 15) |
|---|---|
| Age, (years) | |
| Range | 18.0 – 59.0 |
| mean | 34.0 (±12.8) |
| Gender, n (%) | |
| Female | 14 (93.3%) |
| Male | 1 (6.7%) |
| Procedures performed, n (%) | |
| Cosmetic Breast Reduction | 12 (80.0%) |
| Oncoplastic Breast Reduction | 1 (6.7%) |
| Gynecomastia Correction | 1 (6.7%) |
| Mastopexy | 1 (6.7%) |
Blood loss: Using the Wilcoxon signed-rank test to compare the two paired groups for significant differences, it was found that the median (IQR) blood loss from weighing (Fig 1A) was statistically different (p=0.0031) when the surgical blade method was compared to the diathermy method (25.4, 11.4-49.4 versus 10.0, 4.0-20.0) mL respectively. Similarly, a statistically significant difference (p=0.002) was reported when an analysis of blood loss from the anaesthetists’ estimates was performed from the two methods (Fig 1B). The median blood loss as estimated by the anaesthetist was 50 (25-80) mL when the surgical blade was used and 20.0 (10.0-40.0) mL with diathermy use respectively (p=0.002). The anaesthetist estimates were always higher than the scientifically measured values. The total blood loss from the surgical blade arm was always more than double that of the diathermy group irrespective of measurement method.
Box and whisker plots showing the median and interquartile ranges of the amount of blood loss recorded from using the surgical blade and the diathermy in milliliters as determined by a scientific scale (A) or the anaesthetist's estimates (B).
A pairwise correlation was used to determine linearity in the reporting of blood loss by the anaesthetists’ visual estimation method compared to the scientific method of measuring blood loss by weighing with the time correction factor considered. Importantly, there was a positive correlation (r=0.6312, p<0.0001) between the anaesthetists’ estimate of blood loss and the actual blood loss measured using the scientific scale (Fig 2.). This finding suggests that the anaesthetist's estimates correlated as high or low between the techniques when measured using the scale.
A scatter diagram showing the correlation between actual measured blood loss and the anaesthetist estimated blood loss.
Time to de-epithelialize: The median (IQR) time taken to de-epethilialize with the two methods, was 13 (11-21) minutes using the surgical blade and 13 (12-46) minutes with diathermy use. Although the IQR for the diathermy method was wider compared to when the surgical blade was used, the findings were not significant when the Wilcoxon signed-rank test was used (p = 0.27).
Nipple viability: Examination of the breasts to determining viability upon pinprick with a needle resulted in a viability frequency of 100% between the two methods suggesting no differences between the two methods (data not shown). Furthermore, during the follow period, no differences in peri-areolar scaring was observed.
Nipple sensation: Nipple sensation measured using the Semmes-Weinstein Monofilament test resulted in the same outcome between the groups. Given that most of the patients experienced similar sensations pre and postoperatively, the values for this test were not captured. Instead, intact or absence of sensation was noted as the results. There was 93.3% (n=14/15, p >0.99) sensation reported for both groups.
The complication rate in the surgical blade group was 6.7% (n=1) while no complication was reported in the diathermy group. There was no statistical significance probably due to small numbers. The complication encountered was a hematoma, which was successfully evacuated.
DISCUSSION
To our knowledge, this study was the first of its kind comparing the two techniques on the breasts of the same patient operated on simultaneously. This study demonstrated that using diathermy can be beneficial when performing pedicle de-epithelialization during breast reduction procedures. The amount of blood loss was significantly reduced during the procedure when diathermy was used. On average, the overall rate of blood loss from the surgical blade group was more than double that from diathermy method (2.56 mL/minute versus 1.09 mL/minute, respectively). Minimizing blood loss is the desire of any surgeon as it ensures a good outcome for patients since bleeding can interfere with the precision of the procedure by obscuring the operative field (14). Generally, the higher the blood loss, the greater the trauma experienced and hence the increased risk of hematoma formation (15). This is likely to be the reason why one patient from the surgical blade group developed a hematoma. This suggests that this method is beneficial not only to the surgeon but most importantly, the patient's overall outcome. We recognize that the variation introduced by the number of surgeons could influence these results as ideally, only one surgeon should be performing the procedures. In a future study with larger numbers, the surgeon's experience level should also be considered. Furthermore, while the procedure was not bloodless as reported in a similar study by Barr's group, we found that there were no significant differences in operative time when we compared our findings to those of Barr and colleagues (7). However, unlike Barr and colleagues, our within-patient controlled study design for the different procedures, reduces bias that could arise from performing these procedures on breasts from different patients.
An additional finding in this study was the difference between the actual measured blood loss and the estimated blood loss provided by the anaesthetist. Many units across South Africa depend on the anaesthetist to estimate the amount of blood loss. However, this method is not accurate when compared to weighing with a scientific scale and can be influenced by several factors such as the experience level of the anaesthetist. The more accurate scientific method that was employed was to weigh swabs before and after use and subtract the difference. This study confirmed that the anaesthetists’ method of estimating blood loss by visual assessment was not accurate as compared to weighing of the swabs after use, although there was a positive correlation between the two methods. The recommendation from this study is that anaesthetists should not only estimate, but also always measure the blood loss using a scale, especially in procedures where accurate measurements can inform patient management.
There was no significant difference in the time taken to de-epithelialize using the two methods. During follow-up examinations, patients did not show any cyst formation suggesting that the visual examination was sufficient. However, future studies should include a histological component.
The safety of the procedure to ensure viability of the nipple is an important consideration during de-epithelialization. Both methods used for de-epithelialization resulted in viable nipples in all patients. This was an important finding especially for the diathermy group as it suggests that there are comparable safety levels to that of the surgical blade.
Although nipple sensation is important, the nerve responsible for nipple sensation comes from deep within the breast parenchyma. This means that theoretically, the method used for pedicle de-epithelialization should not affect the nipple sensation. Furthermore, patients have variability in outcomes of nipple sensation following breast reduction procedures. Outcomes can range from having no sensation to hypersensitivity. Even with these considerations in mind, it is important to make sure that if diathermy use is considered, it should be comparable with the standard of care in all parameters measured during a breast reduction procedure. In this study, the procedures proved to be comparable except for one patient from each group that reportedly lost sensation in a breast during post-operative examination.
Only one breast had a hematoma collection in the surgical blade group (p>0.05). Hematoma formation during breast operations usually comes from bleeding from blood vessels within the breast tissue itself. Bleeding from the pedicle is usually dermal and thus it is not enough to cause a hematoma formation. One can thus infer that the hematoma formation encountered in the surgical group was not associated with the de-epithelialization method. A separate observation, which was not part of the study, was reports by some of the surgeons that using diathermy was associated with the emission of smoke, which can be troublesome. This finding is in agreement with reports by Khan and colleagues in 2005, who reported that the smoke was a nuisance (7). However, none of the surgeons in this study felt that the smoke was troublesome enough to abort the procedure. Furthermore, there are ways of mitigating this by using a diathermy with suction tips or in our case using a separate suction which is always available in the operation field.
There were no significant differences in parameters such as time, nipple sensation and viability. It is important to note that these are important findings of this study. When advocating use of an alternative method from the standard of care, that alternative method has to be safe, with no additional adverse effects and has to be associated with added advantages e.g. maintained nipple sensation and reduction of blood loss. This study opens possibilities of research in the use of electrocautery devices in the field of breast surgery and other procedures where there is flap involvement.
A limitation of this study could be that the surgeons involved were informed upfront that the procedure will be timed. This could have made them focus on the task at hand to eliminate any delays, hence influencing their performance and time to complete the task. In addition, given that diathermy produces a surface that could be difficult to assess with the eye as opposed the surface operated with the blade, a histological examination of the de-epithelialized surface to determine the completeness of epidermal ablation could be considered in future studies.
CONCLUSION
This study has shown that for breast reduction surgery the diathermy procedure is as safe as the surgical blade during pedicle de-epithelialization. All nipples sensation survived with the use of diathermy and loss of sensation was comparable between the two methods. The main advantage of using diathermy was a significant decrease in blood loss as compared to the use of the surgical blade. This study should encourage surgeons to incorporate the diathermy method in their practice for breast reduction since a reduction in blood loss in any surgical procedure is a significant advantage.
DECLARATIONS
Authorship
TN and EN contributed to the conception of the study, TN, EN and PF to the design, TN and PF contributed to the analysis and data interpretation. TN was involved in the drafting of the original manuscript while PF revised the entire document for important intellectual content. All authors approved of the version being published.