Abstract TITLE: Effect of intra-operative and post-operative topical tranexamic acid on early post-operative complications in patients undergoing axillary lymph node dissection for breast cancer. Authors: PACHIMATLA AKHIL GOUD1, ISHITHA LARAOIYA2, SIDDHANT KHARE3, R N NAGA SANTHOSH IRRINKI2, GURPREET SINGH4. Affiliation: 1. Junior Resident, Department of General Surgery, Post Graduate Institute of Medical Education & Research (P.G.I.M.E.R.), Chandigarh. 2. Assistant professor, Department of General Surgery, Post Graduate Institute of Medical Education & Research (P.G.I.M.E.R.), Chandigarh. 3. Associate professor, Department of General Surgery, Post Graduate Institute of Medical Education & Research (P.G.I.M.E.R.), Chandigarh. 4. Professor and Head (retired), Department of General Surgery, Post Graduate Institute of Medical Education & Research (P.G.I.M.E.R.), Chandigarh. BACKGROUND: Seroma formation after breast surgery has been a consistent problem with no established causes or risk factors. The role of topical tranexamic acid in reducing the incidence of seroma after axillary clearance in breast cancer is controversial. AIMS & OBJECTIVES: To study the effect of intra-operative and post-operative topical Tranexamic acid on the duration of drain and volume of seroma in patients undergoing axillary lymph node dissection (ALND) for breast cancer. MATERIALS AND METHODS: In this prospective, non-blinded, triple-arm randomized controlled trial conducted at the Department of General Surgery, PGIMER, 154 breast cancer patients were enrolled and studied from July 2020-July 2021. They were randomized into three groups. Group A (n=51) received a single dose of diluted topical tranexamic acid intra-operatively, Group B (n=52) received intra-operative dose and daily post-operative doses till day-5 through the suction drain placed intra-operatively, and Group C(n=51) did not receive any topical tranexamic acid. The study groups were primarily compared for the total drain duration and total drainage volume. Daily drain volume for the first five days, complications like seroma, wound infection and severity of surgical site infections using Southampton score, and adverse reactions of the drug were compared. RESULTS Out of the 154 patients, four have failed to maintain appropriate records and analysis was done with 150 patients. The mean age of the study population was 52.17±8.69 yrs, with a mean BMI of 26.20±4.14. The final analysis showed no significant difference in total drain volume across the three groups, but patients receiving multiple doses of topical tranexamic acid had the lowest total volume drained compared to patients receiving a single dose or no dose (1763ml Vs 1597 Vs 1773ml: p=0.269. There was no significant change in the duration of the post-operative drain (21.6 Vs 19.2 Vs 19.55 days: p=0.54). There was no statistically significant difference in complications between the groups. Seroma was seen in 6 vs 7 vs 4%(p=0.629) patients in groups A, B and C respectively. Wound site infection was noted in 11 vs 13 vs 10% of patients (p= 0.766). None of the patient characteristics like age, BMI, co-morbidities, previous lumpectomy, menopause, and length of history significantly correlated with seroma formation in the study population. CONCLUSION There was no significant reduction in drain volume or duration with either single or multiple doses of topical tranexamic acid after the axillary clearance for breast cancer. Even though not significant, an increasing trend in wound site infections was noted among the patients who received multiple doses of tranexamic acid was noted. Citation Format: AKHIL GOUD PACHIMATLA, R N NAGA SANTOSH IRRINKI, ISHITA LAROIYA, SIDDHANT KHARE. Effect Of Intra-operative And Post-operative Topical Tranexamic Acid On early post-operative complications In Patients Undergoing Axillary Lymph Node Dissection For Breast Cancer- A randomized controlled study. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-14.
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