Single vs. double drain in modified radical mastectomy: A randomized controlled trial

Abstract

Objective: It was aimed to test the hypothesis that the use of a double drain results in less seroma formation, duration of the hospital stay, surgical site infection (SSI), postoperative pain, hematoma, flap necrosis compared to a single drain in patients undergoing modified radical mastectomy. Material and Methods: This parallel-group, single-institution randomized controlled trial was conducted at the department of surgery of our institute between April 2015 and July 2018. Women undergoing modified radical mastectomy were randomly allocated to either a single drain (n= 98) or double drain (n= 98). Results: Both groups were comparable for baseline variables such as age, co-morbidity, BMI, and tumor characteristics. The variables of single drain yielded no better outcomes compared to double drain with estimated blood loss (101.67 ± 25.14 vs.101.67 ± 24.40, p> 0.001), drain volume (898.81 ± 116.42 vs 803.97 ± 103.22 mL, p> 0.001), duration of surgery in minutes (103.19 ± 15.96, 103.19 ± 15.93) and seroma formation (13.4% vs 6.1%, p= 0.082). However, single drain yielded less postoperative pain (mean 2.5 ± 0.70 vs 5.22 ± 5.10, p< 0.000). On multivariable Cox regression analysis, single drain was associated with a lower risk of significant postoperative pain [adjusted relative risk 0.14 (95% confidence interval (CI) 0.070-0.25)] and overall complications [adjusted relative risk 0.47, (95% CI 0.26-0.86)]. On multiple linear regression, the duration of drains in the single drain group was 0.01 days less than double drain (r2= 0.00, b= 0.388, p> 0.001). Conclusion: The use of a single drain significantly reduces postoperative discomfort and pain while demonstrating similar morbidity to the patient with two drains. We thus recommend preferential use of a single drain in modified radical mastectomy (NCT02411617).