|Year : 2018 | Volume
| Issue : 4 | Page : 348-358
Comparison of harmonic scalpel and conventional technique in the surgery for breast cancer: A systematic review and meta-analysis
Zili Zhang, Lin Li, Yi Pang, Qi Li, Chunli Guo, Yongchao Wang, Chengpei Zhu, Xiangchao Meng
Department of General Surgery, Third Central Hospital of Tianjin, The Third Central Clinical College of Tianjin Medical University, Artificial Cell Engineering Technology Research Center of Public Health Ministry, Tianjin Key Laboratory of Artificial Cell, Tianjin Institute of Hepatobiliary Disease, Tianjin, China
|Date of Web Publication||28-Feb-2019|
Department of General Surgery, Third Central Hospital of Tianjin, The Third Central Clinical College of Tianjin Medical University, Artificial Cell Engineering Technology Research Center of Public Health Ministry, Tianjin Key Laboratory of Artificial Cell, Tianjin Institute of Hepatobiliary Disease, Tianjin
Source of Support: None, Conflict of Interest: None
BACKGROUND: Harmonic scalpel is considered as a promising surgical tool for breast cancer, while its advantage over conventional approach is still controversial. Therefore, we performed this meta-analysis to compare the outcomes of harmonic scalpel and conventional tools in the surgery for breast cancer. MATERIALS AND METHODS: Studies reporting the outcomes of harmonic scalpel and conventional technologies were systematically searched from online databases, PubMed and EMBASE up to April 30, 2018. Data were presented as odds ratio, risk ratio (RR), and mean difference (MD) with 95% confidence interval (CI). RESULTS: Intraoperative blood loss (I2 = 96%, P < 0.05, MD = −68.78, 95% CI −93.31 to −44.24), seroma (I2 = 3%, P = 0.41, RR = 0.63, 95% CI 0.46–0.86) and hematoma formation (I2 = 0%, P = 0.64, RR = 0.41, 95% CI 0.23–0.73), drainage volume (I2 = 89%, P < 0.05, MD = −105.33, 95% CI −161.33 to −49.33) and time (I2 = 93%, P < 0.05, MD = −2.18, 95% CI −3.75 to −0.61), necrosis (I2 = 35%, P = 0.20, RR = 0.37, 95% CI 0.16–0.86), surgical duration (I2 = 79%, P < 0.05, MD = −8.49, 95% CI −16.56 to −0.43), and hospital stay (I2 = 97%, P < 0.05, MD = −0.94, 95% CI −1.74 to −0.14) are significantly different between the two groups. CONCLUSIONS: Harmonic scalpel is superior to conventional tools in terms of decreasing intraoperative blood loss, seroma and hematoma formation, drainage volume and time, necrosis prevalence, surgical duration, and hospital stay, which should be strongly recommended in the surgery for breast cancer.
Keywords: Breast cancer, electrocautery, harmonic scalpel, hemostasis, mastectomy
|How to cite this article:|
Zhang Z, Li L, Pang Y, Li Q, Guo C, Wang Y, Zhu C, Meng X. Comparison of harmonic scalpel and conventional technique in the surgery for breast cancer: A systematic review and meta-analysis. Indian J Cancer 2018;55:348-58
|How to cite this URL:|
Zhang Z, Li L, Pang Y, Li Q, Guo C, Wang Y, Zhu C, Meng X. Comparison of harmonic scalpel and conventional technique in the surgery for breast cancer: A systematic review and meta-analysis. Indian J Cancer [serial online] 2018 [cited 2019 May 21];55:348-58. Available from: http://www.indianjcancer.com/text.asp?2018/55/4/348/253289
| » Introduction|| |
Breast cancer is one of the most prevalent cancers worldwide, which has become a leading cause for tumor mortality in women. A report on breast cancer among women carried out by the American Cancer Society revealed that 1 in 8 (about 12%) women in the United States will be diagnosed with breast cancer in their life span. In European Union, it is predicted that there will be approximately 394,000 new cases of breast cancer each year and 100,000 deaths. In China, the incidence of breast cancer has risen to 12.2% with 9.6% mortality.
Surgery is one of the best ways for breast cancer treatment, in which three major approaches are generally used: total mastectomy, modified radical mastectomy (MRM), and breast-conserving surgery (BCS). Although several clinical trials ,,,, demonstrated equivalent survival between BCS and mastectomy in patients with early-stage breast cancer, the former is still seldom used in younger women., Since the first adoption in 1970s, electrocautery has become a popular surgical tool for breast dissection, which can stop blood loss by sealing vessels. However, it also leads to higher risk of postoperative seroma formation and thermal injury, which may stimulate wound infection, skin necrosis, and so on. Harmonic scalpel (HS) is a safe and effective alternative for surgical dissection and hemostasis used in laparoscopic surgery at the beginning, which may contribute to less blood loss, drainage, and seroma.,
However, there is still a debate on the advantage of HS compared with conventional approaches. Therefore, the aim of this meta-analysis was to compare the outcomes of HS and conventional methods including scissor and electrocautery in the treatment of breast cancer.
| » Materials and Methods|| |
This article follows the PRISMA and the Cochrane Collaboration guidelines for reporting meta-analysis.
Studies published in English up to April 30, 2018 were retrieved from online databases, PubMed and EMBASE. Abstracts containing the outcomes of HS and conventional surgical approaches such as scissor and electrocautery in the treatment of breast cancer were chosen, with the following search terms: “harmonic scalpel” OR “ultrasonic scissor” OR “electrocautery” OR “cautery” AND “breast cancer” OR “mastectomy” OR “modified radical mastectomy” OR “breast-conserving surgery.” Citation lists of relevant articles and reviews were additionally scanned to identify further studies of interest.
Studies published in English meeting the following selection criteria were enrolled in the meta-analysis : patients diagnosed with early breast cancer without any preoperative treatment ; the study must compare the outcomes of HS and conventional surgical methods ; and research outcomes containing at least one available data of interest as follows: intraoperative blood loss, volume and time for drainage, postoperative complications, flap necrosis, wound infection, operating time, and hospital stay. Studies without assessable data for statistical analysis or non-original studies such as review, letter, and comment were excluded. Discrepancies were resolved by referring the original articles or group discussion of all the authors.
All retrieved records from individual studies were screened and extracted using standardized forms. Following details were extracted from each study: first author, year of publication, baseline characteristic of participants, surgical tools, surgical type, and research type.
Quality assessment and risk of bias
According to the Cochrane Handbook of Systematic Review of Interventions, randomized controlled trials (RCTs) were assessed using Review Manager 5.3 based on seven perspectives (random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and others) and scored as unclear, low, or high risk of bias. Controlled clinical trials were assessed using The Newcastle-Ottawa Scale based on three perspectives (selection, comparability, and outcome of cohort). Details are presented in [Figure 1] and [Table 1], respectively.
|Figure 1: Risk of bias of included randomized controlled trials (a) risk of bias summary; (b) risk of bias graph|
Click here to view
All statistical analyses were performed by Review Manager 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark, 2014). Dichotomous data were analyzed using risk ratio (RR) for RCTs and odds ratio (OR) for non-RCTs, and continuous data were analyzed using mean difference (MD) with 95% confidence intervals (95% CIs).
I2 (inconsistency index) and Q statistic were performed to assess heterogeneity. I2 describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance). The Q statistic indicates whether the individual effects are farther away from the common effect, beyond what is expected by chance. An I2 value >50% or P- value <0.05 may be considered substantial heterogeneity, and random effects model would be selected; otherwise, fixed effects model would be employed. Sensitivity analysis was performed to confirm the robustness of the results by omitting one study at a time.
| » Results|| |
The detailed manuscript screening processes were presented in [Figure 2]. According to the search criteria, 964 articles were originally retrieved from the databases and 31 from manual search of citation list. A total of 792 studies remained after duplicates were removed, among which 565 studies were excluded by reviewing the title and abstract according to the selection criteria. Of these researches, 102 did not report relative outcomes of interest, 295 were case reports, 147 were editorial letters or comments, and 21 were reviews. After full assessment of 49 articles, 27 were removed for not reporting detailed way of diagnosis and surgery. In the end, 2 were excluded for lack of original data and 20 studies were enrolled for this meta-analysis.
Characteristics of included studies
In the 20 enrolled articles ,,,,,,,,,,,,,,,,,,, published from 2002 to 2016, 10 are RCTs and 10 are non-RCTs; traditional scissor or both scissor and electrocautery compromised the control group in 4 studies, mastectomy or MRM are reported in 10 studies, 5 studies only performed axillary dissection (AD), and breast reconstruction surgery was employed in 3 articles. Details are presented in [Table 1].
In the analysis, intraoperative blood loss, seroma, hematoma, volume, and time of postoperative drainage would be served as the main endpoints; besides, overall complications, infection, necrosis, surgical time, and hospital stay represent secondary endpoints.
Intraoperative blood loss
Nine studies ,,,,,,,, with a total of 785 participants included the data of blood loss during surgery. Notable heterogeneity was detected (I2 = 96%, P < 0.05), random effects model was applied. As shown in [Figure 3], significant difference can be observed between the HS and the non-HS group (MD −68.78, 95% CI −93.31 to −44.24). Results are consistent in both RCT and non-RCT subgroups (MD = −33.62, 95% CI −53.17 to −14.06; MD = −161.95, 95% CI −300.60 to −23.30).
Seroma and hematoma formation
Eleven researches ,,,,,,,,,, with a total of 927 participants reported seroma. Less heterogeneity was found (I2 = 3%, P = 0.41) and fixed effects model was employed. As shown in the forest plot, HS is significantly effective in controlling seroma formation (RR = 0.63, 95% CI 0.46–0.86). Results are consistent in the RCT subgroup (RR = 0.49, 95% CI 0.31–0.77), while statistics did not reach significant difference in the non-RCT subgroup (OR = 0.76, 95% CI 0.46–1.26).
Five articles ,,,, with a total of 549 patients reported hematoma development. No heterogeneity was observed (I2 = 0%, P = 0.64) and fixed effects model was used. HS can significantly reduce the prevalence of hematoma compared with non-HS methods (RR = 0.41, 95% CI 0.23–0.73). Results are consistent with overall outcome in the RCT subgroup (RR = 0.39, 95% CI 0.21–0.74), but there is no significant difference in the non-RCT subgroup (OR = 0.52, 95% CI 0.11–2.47). Details are presented in [Figure 4].
Fourteen studies ,,,,,,,,,,,, with a total of 1012 patients analyzed postoperative drainage volume. Obvious heterogeneity can be observed (I2 = 89%, P < 0.05) and random effects model was adopted. Drainage volume was significantly different between the HS and the non-HS group (MD = −105.33, 95% CI −161.33 to −49.33). However, there is no significant difference in the non-RCT subgroup (MD = −105.33, 95% CI −161.33 to −49.33).
In terms of drainage time, eight studies ,,,,,,, with a total of 682 patients were enrolled. Heterogeneity was notably high (I2 = 93%, P < 0.05) and significant difference was detected between the HS and the non-HS group (MD = −2.18, 95% CI −3.75 to −0.61). Besides, there is no statistical difference in the non-RCT subgroup (MD = −2.18, 95% CI −3.75 to −0.61). Detailed are presented in [Figure 5].
Six manuscripts ,,,,, with a total of 528 patients reported overall complications. Large heterogeneity (I2 = 74%, P < 0.05) was observed and random effects model was used. As presented in [Figure 6], there is no significant difference between the HS and the non-HS group (RR = 0.76, 95% CI 0.40–1.42). The pooled diamond still favor the HS group in the RCT subgroup (RR = 0.54, 95% CI 0.28–1.03), while there is no significant difference in the non-RCT subgroup (OR = 1.81, 95% CI 0.21–15.70). Details are presented in [Figure 6](1).
Six articles ,,,,, with a total of 439 patients reported wound infection after surgery. Less heterogeneity was detected (I2 = 16%, P = 0.31) and fixed effects model was employed. The result shows that there is no significant difference between the two groups with regard to infection (RR = 1.06, 95% CI 0.49–2.32). Outcomes from the subgroup analysis were consistent with the overall results. Details are presented in [Figure 6](2).
Four studies ,,, with a total of 346 patients referred flap necrosis after the operation. Less heterogeneity (I2 = 39%, P < 0.18) was observed and fixed effects model was employed. There is no significant difference between two groups (RR = 0.45, 95% CI 0.13–1.56). The results of necrosis in the RCT subgroup were consistent with overall outcomes (RR = 0.23, 95% CI 0.08–0.65), but there is no significant difference between the two groups in the non-RCT subgroup (OR = 2.34, 95% CI 0.31–17.37). Details are presented in [Figure 6](3).
Thirteen articles ,,,,,,,,,,,, with a total of 1074 participants were enrolled for the comparison on surgical time. Large heterogeneity was observed (I2 = 79%, P < 0.05), therefore random effects model was employed. As shown in [Figure 7](1), there is a significant difference between the HS and the non-HS group (MD = −8.49, 95% CI −16.56 to −0.43). In the subgroup analysis, results in the RCT subgroup are consistent with overall outcomes (MD = −9.23, 95% CI −19.43 to 0.98), while there is no significant difference in the non-RCT subgroup (MD = −8.05, 95% CI −16.56 to −0.43).
Seven researches ,,,,,, with a total of 551 participants reported hospital stay after surgery. Notably large heterogeneity (I2 = 97%, P < 0.05) was detected and random effects model was used. As presented in [Figure 7](2), there is a significant difference between the two groups (MD = −0.94, 95% CI −1.74 to −0.14). Results are consistent in the RCT subgroup (MD = −1.35, 95% CI −2.37 to −0.34), while no significant difference was observed in the non-RCT subgroup (MD = −0.19, 95% CI −0.97 to 0.59).
In order to deliver a more accurate result, we performed subgroup analysis on drainage volume, seroma, hematoma, overall complications, infection, and necrosis from three perspectives: surgical tool (HS versus scissor or electrocautery and scissor), surgical method (MRM versus non-MRM), and age (≤55 versus >55). In terms of drainage volume, the non-HS group had larger drainage volume in the HS versus electrocautery (MD = −147.45, 95% CI −223.47 to −71.43) subgroup and non-MRM subgroup (MD = −75.06, 95% CI −140.73 to −9.39). Non-HS patients had more seroma in the non-MRM subgroup (RR = 0.49, 95% CI 0.28–0.84) and age >55 subgroup (RR = 0.49, 95% CI 0.31–0.77). More hematoma can be observed on patients who underwent electrocautery in the HS versus electrocautery subgroup (RR = 0.24, 95% CI 0.08–0.76) and on non-HS patients in the non-MRM subgroup (RR = 0.42, 95% CI 0.22–0.81) and age >55 subgroup (RR = 0.49, 95% CI 0.31–0.77). Necrosis was frequent on electrocautery patients in the HS versus electrocautery subgroup (RR = 0.34, 95% CI 0.14–0.82) and on non-HS patients in the MRM subgroup (RR = 0.27, 95% CI 0.10–0.70). There is no significant difference regarding overall complications and infection. Details are presented in [Table 2].
| » Discussion|| |
In this meta-analysis, we compared the outcomes between HS and conventional tools in breast cancer surgery, and demonstrated that HS can significantly reduce the prevalence of intraoperative blood loss, drainage volume and time, seroma and hematoma development, necrosis, surgical duration, and hospital stay.
Electrocautery has been reported to be correlated with morbidity in breast cancer patients after MRM, featured with blood loss, prolonged axillary drainage, seroma and hematoma formation, and flap necrosis. Besides, electrocautery is also associated with thermal tissue injury which may lead to the lesion in subdermal vascular plexus and incomplete occlusion of vascular and lymphatic channels., HS is a safe and effective surgical technology for dissection and hemostasis, which uses ultrasonic energy to seal off the vessels and lymphatics by disintegrating hydrogen bonds and forming denatured protein coagulum, thus resulting in less intraoperative blood loss and postoperative drainage volume, which are consistent with our findings. In the subgroup analysis of drainage volume, we also found that HS led to less drainage compared with electrocautery. Besides, it is interesting that the control group combined with scissor and electrocautery resulted in less drainage than the harmonica group in 3 studies. After reviewing these articles, we found that one article was a non-randomized study whose control group has two times patients than the harmonica group; another two articles did not exclusively use HS in the AD surgery.
Seroma is the most prevalent postoperative complication after AD, although its mechanism is still unclear. It is generally believed that seroma generates from the inflammatory exudate of wound surface and the leakage of lymphatic fluid. In this meta-analysis, the results show that HS lead to less seroma formation, which are consistent with previous literatures. A few studies also revealed the effectiveness of fibrin sealant on controlling seroma formation by sealing blood and lymph vessels., Some researchers found that breast conservation, neoadjuvant chemotherapy, surgeon technique, cold scalpel, young age, non-smoker, and healthy body mass index  may contribute to decreased seroma. In the subgroup analysis of seroma, the HS group delivered better results in the patients who underwent non-MRM surgery which includes breast conservation surgery. Besides, Galatius et al. and Iovino et al. conceded that employing HS for both breast surgery and AD may cause less inflammatory reaction and further reduce seroma,, and the whole surgery in most included studies of this analysis was exclusively conducted by HS in the HS group. In addition, postoperative bleeding and seroma formation have become the primary reasons for extensive hospital stay after breast surgery, which is consistent with our results.
In terms of flap necrosis, our results show that the HS group has less prevalence than conventional methods. Some studies concede that it may account for different temperatures in the two groups: HS was performed at 80°C and electrocautery up to 400°C, and lower temperature may deliver a more precise dissection with less severe thermal lesions.
In the subgroup analysis regarding drainage volume, seroma, hematoma, and necrosis, significant difference can be observed in the subgroup of surgical methods and patient age, which may imply that non-HS may deliver worse outcome for patients above 55 years who undergo non-MRM surgery. After further comparison of data in different subgroups, we found that both the HS and the non-HS groups had decreased seroma in the non-MRM subgroup which is composed of breast conservation surgery and exclusively AD surgery, but the non-HS group presented much more seroma prevalence in the non-MRM subgroup. Gonzalez et al. had demonstrated that patients who received breast conservation surgery had less seroma formation than those with MRM. In terms of surgical age, we observed that seroma prevalence in the HS group reduced in the age >55 subgroup, but the prevalence raised in the non-HS group, indicating the association between age and breast surgery outcome which has been detected in few studies.,, On the other side, there are certain inestimable studies regarding hematoma and necrosis which may lead to bias, therefore we decided to ignore the subgroup analysis of these two factors. Besides, further studies are needed to verify the above findings.
Two previous meta-analyses reveal that there is no significant difference in surgical duration between harmonica scalpel and conventional methods in mastectomy for breast cancer. In this study, however, we found that HS can significantly decreased operative time in overall analysis and RCT subgroup, which may result from the proficiency of using HS. In its first employment for mastectomy, HS took longer time to complete the surgery, while the surgical time decreased with experience and the mean surgical time was comparable with electrocautery. After verifying these two articles, we also found that the published year of their included studies are older than ours, which may influence the final results.
On the other side, we detected that HS may lead to shorter hospital stay after surgery. Although the cost of HS is higher than electrocautery, which is about €510 and €110 per patient respectively in Italy, less postoperative complications and hospital stay may justify the additional cost.
| » Conclusions|| |
We compared the outcomes between HS and traditional tools for breast cancer surgery including mastectomy, BCS, and AD, and found that HS is a safe and effective surgical tool in terms of decreasing intraoperative blood loss, seroma and hematoma formation, drainage volume and time, flap necrosis, surgical duration, and hospital stay, which deserve more application in the surgery for breast cancer.
However, there are some limitations within this study. First, we combined RCT and non-RCT in the meta-analysis, leading to significant heterogeneity in several items which cannot be addressed in the subgroup analysis and sensitivity analysis. Second, even though tumor status, axillary management, body mass index, and so on are comparable in most studies, the surgery method is varied in different studies, which may influence the final results. Therefore, further study is still needed to verify our findings.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
[Table 1], [Table 2]