Active Drainage versus Passive Drainage after Modified Radical Mastectomy in Patients with Breast Carcinoma: A Randomised Controlled Trial

Abstract

Introduction: Postoperative seroma formation is a common complication following Modified Radical Mastectomy (MRM), with an incidence ranging from 15-60%. There is a hypothesis that the negative pressure created by the suction drain used in MRM opens the damaged capillaries, preventing them from spontaneously closing and thereby increasing postoperative secretions. Aim: To compare active suction drains with passive drains in MRM in terms of postoperative outcomes. Materials and Methods: A randomised controlled trial with two arms, consisting of 15 patients in each arm, was conducted from November 2018 to March 2020 at the Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital in New Delhi. Patients diagnosed with localised breast carcinoma and scheduled for MRM were invited to participate. Pregnant females, patients with metastatic disease, those lost to follow-up, recurrent breast cancer patients, and those taking anticoagulants and antiplatelet agents were excluded from the study. The outcomes measured were drain output and duration of hospital stay, and postoperative morbidity, including flap necrosis, surgical site infection, seroma, and volume of seroma aspiration. The data acquired was analysed using the Statistical Package for Social Sciences (SPSS) version 21.0. Quantitative variables were compared using the Independent t-test and Mann-Whitney test as appropriate. Nominal categorical data was compared using the Chi-square or Fisher’s-exact test as appropriate. Results: Drain output was higher in the active group than in the passive group, but there was no significant difference in the average daily drain output and the average total output (652 mL versus 540 mL), except for the first two postoperative days. There was no statistically significant difference between the two groups in terms of hospital stay (6.67 days and 6.27 days), duration of drains in situ (6.67 days and 6.27 days), flap necrosis (13.3% vs. 13.3%), seroma formation (26.67% vs. 20%), and surgical site infection (26.67% vs. 20%). Conclusion: The use of suction in drains during MRM surgery is not compulsory and can save costs in resourcepoor settings. However, larger sample size studies with multicentre participation should be undertaken before making any recommendations.