What Is the Optimal Strategy for Drain Removal After Mastectomy and Axillary Surgery in Breast Cancer Patients? A Multicenter, Three-Arm Randomized Clinical Trial

Abstract

Introduction: The best strategy for drain removal after mastectomy and axillary surgery in breast cancer patients has remained controversial. We conducted a multicenter, three-arm randomized clinical trial to determine the optimal strategy.

Methods: A total of 187 eligible breast cancer patients who underwent mastectomy and axillary surgery were randomized into 10 mL (n = 62), 20 mL (n = 63), and 30 mL (n = 63) groups for drain removal on the first day when the output decreased to a corresponding volume in 24 h. The drain duration, total drain duration, incidence of seroma, quality of life, outpatient visit times, healthcare costs, and postoperative complications were evaluated.

Results: The median axillary drain durations and total drain durations were all significantly different between three groups (both P < 0.001). The incidences of seroma were 31.1%, 38.3%, and 52.1%, and the difference between the 30 mL and 10 mL groups was significant (RR = 2.41). The 20 mL group reported significantly better quality of life (QoL) in terms of physical functioning (PF) at the 2-week (30 mL versus 20 mL, HR:-14.18) and 3-week (20 mL versus 10 mL, HR: 11.65) follow-up and role functioning (RF) at the 2-week follow-up (20 mL versus 10 mL, HR: 18.15). No between-group differences were found in G-QoL, outpatient visits, costs, or complications.

Conclusions: The 20 mL group had a moderate drain duration, total drain duration, and incidence of seroma but a significant advantage over the other two groups in terms of PF and RF, with relatively low outpatient costs and comparable postoperative complication rates. These findings could aid in clinical decision-making regarding drain removal timing (http://www.chictr.org.cn/: ChiCTR2000028729).

Keywords: Breast cancer; Drain removal; Drainage tube; Seroma.