Effect of Octreotide on Lymphorrhea in Patients After Modified Radical Mastectomy for Carcinoma Breast: A Randomized Controlled Trial.

Abstract

IntroductionLymphorrhea or seroma formation after modified radical mastectomy (MRM) is a serious and disabling complication of axillary lymphadenectomy. Octreotide is a hormone with general anti-secretory effects. The potential role of octreotide in the treatment of lymphorrhea after axillary lymph node dissection in patients undergoing MRM is being investigated in this study. The purpose of this research is to study the effect of octreotide on the magnitude and duration of lymphorrhea in patients after MRM for carcinoma breast.MethodsThis clinical trial was registered in the Clinical Trials Registry India (CTRI/2017/11/010653). It was conducted in the Department of General Surgery, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi from September 2015 to March 2017. This study is a parallel randomized controlled trial with a 1:1 allocation ratio. Thirty patients were enrolled and allocated equally into two groups. The intervention group received standard medical care plus injection octreotide 100 micrograms eight hourly intravenously post-operatively for five days and the control group received only standard medical care. The primary outcomes were lymphorrhea volume from 24 hours post-surgery till five days post-operatively and the number of days till the suction drain was removed. Secondary outcomes were surgical site infection, the incidence of seroma formation, complications of octreotide, duration of hospital stay, and the number of lymph nodes isolated. All the patients were followed up twice a week for the first six weeks after discharge followed by three monthly visits.ResultsA total of 30 patients were included in the study. The mean age was 46.2 years. The mean operative time in the control group was 137.87 ± 23.28 minutes and in the octreotide group was 128.13 ± 12.29 (p = 0.163). The volume of lymphorrhea in the control group was 354.67 ± 346.28 ml and in the octreotide group was 194.00 ± 240.62 ml (p = 0.081). Seroma occurred in 9% of patients in the control group and 2 % of patients in the octreotide group (p = 0.010). The duration of lymphorrhea was 4.93 ± 2.49 days in the control group and 3.13 ± 1.36 days in the octreotide group (p = 0.029). The duration of stay was 7.07 ± 2.40 days in the control group and 5.13 ± 1.06 days in the octreotide and was found to be statistically significant (p = 0.010). No obvious adverse reactions related to injection octreotide, namely, nausea, vomiting, abdominal discomfort, hypotension, bradycardia, and dysglycemia, were seen in any of our patients.ConclusionThe duration of lymphorrhea, incidence of seroma formation, and duration of hospital stay were lesser in the octreotide group, and the difference was statistically significant. The wound infection rates were similar in both groups. Thus injection octreotide can be used safely and effectively.