Single vs. double drain in modified radical mastectomy: A randomized controlled trial
1Department of Surgery, Rehman Medical Institute, Peshawar, Pakistan
2Clinic of Surgery, BronxCare Hospital, New York, USA
3Department of Gynaecology, Bilawal Medical College, Jamshoro, Pakistan
4Department of Research, Colorado Technical University, Texas, USA
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).
Keywords: Modified radical mastectomy, seroma, postoperative pain, single drain
Cite this article as: Khan S, Khan M, Wasim A. Single vs. double drain in modified radical mastectomy: A randomized controlled trial. Turk J Surg 2023; 39 (2): 145- 152.
This study was approved by Memon Medical Institute Hospital Ethics Committee (Decision no: ERC-07-2013 MMIH, Date: 17.05.2014).
Concept - SK, MK; Design - SK; Supervision - SK; Data Collection and/or Processing - SK, MK; Analysis and/or Interpretation - SK, AW; Literature Review - MK, AW; Writer- SK, MK, AW; Critical Review - SK, MK
The authors have no conflicts of interest to declare.
The authors declared that this study has received no financial support.
The author would like to acknowledge the work of Dr. Sadia Rafique, who helped in data collection.