|Year : 2022 | Volume
| Issue : 1 | Page : 11-16
Clinical outcomes after modified radical mastectomy in a tertiary care hospital: An observational study
Akshita Bhandari1, Pankaj P Rao1, Arvind Tyagi2, Dronacharya Routh1, Simarjit S Rehsi1
1 Department of Surgery, Armed Forces Medical College, Pune, Maharashtra, India
2 Department of Oncosurgery, Yashoda Super Specialty Hospital, Ghaziabad, Uttar Pradesh, India
|Date of Submission||21-Apr-2021|
|Date of Acceptance||30-Apr-2021|
|Date of Web Publication||23-May-2022|
Dr. Simarjit S Rehsi
Department of Surgery, Armed Forces Medical College, Pune - 411 040, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Despite advances in medical sciences, modified radical mastectomy (MRM) remains the mainstay of treatment in breast cancer management in India. However, a wide range (0.8%–26%) of postoperative complications occur following MRM. Lacunae exist in the existing extensive medical literature regarding any correlation between preoperative staging and demographic profile of such patients with the incidence of these complications, which might aid in adapting a preventive approach accordingly.
Aim: The aim of this work was to study the association of preoperative tumor size, nodal status, and clinical profile (age, diabetes mellitus, hypertension) of breast cancer patients with the postoperative complications (seroma formation, surgical site infection, wound dehiscence, flap necrosis, paresthesia, and lymphedema).
Methods: All patients diagnosed with carcinoma breast and undergoing MRM.
a. Settings and Design: This was a prospective observational study at a tertiary care hospital.
b. Duration: Two years.
c. Statistical Analysis Used: Data were recorded in an Excel datasheet and statistically analyzed by using the SPSS version 22.0.
Results: A significant positive association was established between seroma formation, wound dehiscence with increasing age (P = 0.006), tumor staging (P = 0.003), and nodal staging (P = 0.022). However, no significant correlation could be established between the other parameters that were studied.
Conclusion: Meticulous surgical techniques and postoperative care should be used to reduce Seroma formation and wound dehiscence in patients with advanced age, higher tumor, and nodal staging.
Keywords: Clinical profile, modified radical mastectomy, post-operative complications, tumor staging
|How to cite this article:|
Bhandari A, Rao PP, Tyagi A, Routh D, Rehsi SS. Clinical outcomes after modified radical mastectomy in a tertiary care hospital: An observational study. J NTR Univ Health Sci 2022;11:11-6
|How to cite this URL:|
Bhandari A, Rao PP, Tyagi A, Routh D, Rehsi SS. Clinical outcomes after modified radical mastectomy in a tertiary care hospital: An observational study. J NTR Univ Health Sci [serial online] 2022 [cited 2022 Aug 8];11:11-6. Available from: https://www.jdrntruhs.org/text.asp?2022/11/1/11/345803
| Introduction|| |
Incidence of breast cancer has been rising steadily and since 2012, breast cancer is the most common female cancer worldwide. In 2012, 144,937 Indian women were newly detected with breast cancer and 70,218 women died of breast cancer.
The modern approach to breast cancer management is multidisciplinary which includes surgery, radiotherapy, hormonal therapy, and chemotherapy. However, surgical management remains the hallmark of treatment. Among the surgical procedures, modified radical mastectomy (MRM) has become the mainstay of treatment, especially in India.
Complications of MRM include seroma formation, surgical site infection (SSI), wound dehiscence, skin flap necrosis, lymphedema, hemorrhage, hematoma formation, paresthesia, and muscle paralysis. These complications can be minimized with careful patient selection and standardized surgical care.
Complications after MRM can be minimized with thorough preoperative evaluation, meticulous technique, hemostasis, and wound closure. Early identification of complications by stratification of risk factors can help in reducing the associated morbidity and mortality.
The aim of this study was to see the correlation of preoperative tumor size, nodal status, and clinical profile of patients, with incidence of these complications and thus helping in predicting the prognosis of such patients with complications, even preoperatively, which would further help in adapting a preventive approach.
This information would help formulate better selection procedures as well as interventional measures thereby reducing the morbidity and mortality associated with surgery for carcinoma of breast.
| Methods|| |
This was a prospective observational study from a tertiary care teaching hospital in Western Maharashtra for 2 years. All female patients who came to the hospital and underwent MRM were included in the study.
A sample size of 120 such patients was taken, observing the trend of previous 3 years cases (65–70 per year). The exclusion criteria of the study were patients who had been operated 2 years prior to the initiation of the study, patients on follow-up, patients with metastatic disease, and those who received upfront neo-adjuvant chemotherapy.
The study was commenced after obtaining mandatory clearance from the institutional ethics committee. Date of Approval: 16 March 2017. All patients diagnosed with carcinoma breast, satisfying the inclusion criteria and exclusion criteria, planned for MRM within the defined timeframe were enrolled in the study, after obtaining written informed consent.
The preliminary data were obtained from patient's hospital documents, personal interview/questionnaire, clinical examination with special emphasis on age, body mass index (BMI), comorbidities (diabetes mellitus, hypertension), and clinical presentation (size of tumor at presentation and nodal positivity). Diagnosis of carcinoma breast was established based on triple assessment. The incidence of complications was noted for the cohort and matched against the risk factors.
The data were tabulated in Microsoft Excel Worksheet for comparison and analysis. The data on categorical variables are shown as n (% of cases). The data on continuous variables are presented as mean and standard deviation (SD). Inter-group statistical comparison of distribution of categorical variables is tested using Chi-square test or Fisher's exact probability test if more than 20% cells have expected frequency less than five. All results are shown in tabular format to visualize the statistically significant difference more clearly. In the entire study, P < 0.05 were considered to be statistically significant. All the hypotheses were formulated using two-tailed alternatives against each null hypothesis (hypothesis of no difference). The entire data are statistically analyzed using the Statistical Package for Social Sciences (SPSS) software program, version 22.0 for MS Windows (IBM, USA).
| Results|| |
A total of 120 patients were included in the study. As shown in [Table 1], the mean ± standard deviation (SD) of age was 51.3 ± 9.7 years with a minimum age of 35 years and maximum age of 70 years. Majority of patients (55.8%) were older than 50 years. Approximately 35 (29.2%) patients had comorbidities with hypertension being the commonest (25%). Only 12 (10%) patients had diabetes either alone or in addition to hypertension.
As shown in [Table 2], the distribution of complications such as seroma [Figure 1], SSI, necrosis [Figure 2] and [Figure 3], and paresthesia differed significantly across various age groups of cases studied (P < 0.05 for all).
|Figure 1: Drains in situ for seroma formation (following left MRM) in one of the patients|
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|Table 2: Comparison of Complications With Risk Factors (* Significant P)|
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Wound dehiscence [Figure 4] even though not being affected by age of the patients, however, was significantly higher for patients with diabetes (P = 0.002).
|Figure 4: Wound dehiscence with SSI (Following Left MRM) in one of the patients|
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There was no significant association with hypertension either alone or in combination with diabetes. In addition, distribution of lymphedema was neither affected by patient's age nor any other co-morbidity.
Tumor and nodal stages of the patient cohort were also compared against the distribution of these complications. Of all the complications studied, only seroma was found to differ significantly between group of cases studied with Tumor staging T2 and T3 and Nodal staging N0 and N1 with a P of 0.003 and 0.022, respectively [Table 2].
Necrosis and dehiscence of flaps, paresthesia, SSI, and lymphedema did not show any variation contrary to the expectation. This was attributed to the better surgical skill set with intensive care and monitoring in the post-operative period by dedicated nursing team.
| Discussion|| |
Breast cancer is one of the most frequent noncutaneous cancer among women. Surgery plays a significant role in management of this carcinoma. MRM and quadrantectomy with lymph node dissection are the methods of choice in most of the cases. The surgical resection of axillary region leads to multiple complications, the most common being seroma formation.,,
Seroma formation further predisposes to SSI, wound dehiscence, flap necrosis, and even sepsis. Appearance of these complications requires repeated visits to the surgeon and necessitate possibly reoperations. It prolongs the period of recovery, creates psychological stress for patients and care givers and eventually increases the economic burden for the patient. The most important therapeutic cost is delay in starting adjuvant therapy leading to potentially further adverse outcome. Hence, it becomes pertinent to study the factors associated with increased risk of complications.
The average age of patients in this index study was 51.3 ± 9.7 years with peak age group being 50–59 years (32.5%) followed by 40–49 years (25.8%). Chandrakar et al. also found maximum number of cases in-between the age group of 40–60 years at 58.53% and the mean age of cases reported by them was 50.90 years with a standard deviation of 11.61 years. Similarly, Dahri et al. in his study of 150 patients observed an average age of 52 years and maximum prevalence of breast cancer in the age group of 40–60 years.
However, in contrast to this study, in the Southeast Asian region of Thailand, Wongbuddha et al. reported maximum prevalence of women presenting with breast cancer in the age group of 40–50 years. The average age was 51.1 years. In contrast, Shaikh FB et al. found a younger average age of presentation at 44.21 years ± 13.43 with peak age group in age range of 41–50 years (37.17%). Kumia et al. in Indonesia, also reported a lower median age at 48.5 ± 8.5 years.
In this study, 32 patients (26.7%) were found to have seroma post MRM. There have been many previous studies that have shown the similar prevalence in patient with MRM. Akinci et al. and Wedgwood et al. showed that seroma formation occurs in 27.5% and 25% of cases, respectively. Chandrakar et al. reported the incidence at 22.96%. However, study by Dahri et al. viewed higher prevalence as 33.3%.
In this study, seroma formation was observed to be significantly associated with increasing age with majority of the cases being more than 50 years in age (75.7%) (P = 0.006). Similarly, the risk also increased with increasing tumor grades.
In this study seroma formation was seen more in patients with higher nodal stages. On evaluating risk with diabetes and hypertension, no association was observed in this cohort. Hypertension was reported as risk factor by Akinci et al. and Kabbash et al.; however, none of the studies list diabetes as a confounding factor.
SSI and paresthesia were noted in 16 cases (13.3%), six cases (5.0%) had wound dehiscence and flap necrosis each, and four patients (3.3%) had lymphedema. In the study by Chandrakar et al., who performed MRM in 41 breast cancer patients; ecchymosis of the flap was seen in 19.51%, 24.39% had SSI, 7.32% had pain at the surgical site and tissue necrosis was observed in 17.07% patients.
In another study by Shaikh et al., the authors evaluated 78 patients undergoing MRM. The main complications observed were seroma formation in 34.6% patients, wound infection in 12.8% patients, skin flap necrosis, paresthesia, and hematoma in 5.1% cases each, wound dehiscence, edema, and muscular paralysis were seen in 3.8%, 2.5%, and 1.2% study population, respectively.
SSI, paresthesia, and tissue necrosis were positively correlated with age. Increase in age led to increased incidence of these complications. Diabetes as has been observed earlier, resulted in increased wound dehiscence.
Thus, in this study advancing age of patients has come out as a significant factor in association with increased risk of complications.
| Conclusion|| |
A significant positive association was established between Seroma formation, Wound dehiscence with increasing age (P = 0.006), tumor staging (P = 0.003), and nodal staging (P = 0.022). However, no significant correlation could be established between the other parameters that were studied.
Meticulous surgical techniques and post-operative care should be employed to reduce Seroma formation and wound dehiscence in patients with advanced age, higher tumor, and nodal staging.
Written Informed consent was obtained from all patients prior to performing the procedure, including permission for publication of all photographs and images included herein.
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]
[Table 1], [Table 2]