To Assess the Role of Biomarkers in Evaluation of Anastomotic Leak Following Planned Colorectal Surgeries To Facilitate Early Removal Of Drain (Controlled Clinical Trial)

PURPOSE There is a need of parameters to predict Anatomotic leak (AL), allay apprehension for early drain removal and facilitate ERAS in patients with colorectal anastomosis. The purpose of this study was to assess the efficacy of biomarkers in the evaluation of anastomotic leak after colorectal surgery, and facilitate early removal of abdominal drain. METHODS It was a Randomised Case Control study with duration of 2 years (April 2021 to March 2023). Patients were followed up for 30 days post-surgery which was conducted in a Tertiary care cancer centre in India. It included a total of 90 patients with biopsy proven Colorectal Carcinoma undergoing elective surgery. They were subjected to 1:1 randomization to case and control group with each arm having 45 patients. Assessment of serum C-Reactive protein, serum Procalcitonin and drain fluid Carcinoembryonic antigen (CEA) level done on postoperative day (POD) 3 and POD 5. USG Whole abdomen screening was done on POD 3 and 5 if all were normal. Drain removed early if all parameters were normal in Cases and as per institutional protocol in controls. RESULTS Mean age of patients was 54.1 years. Two groups were similar with respect to histologic subtypes, rate of lymphovascular/ perineural invasion, rates of lymph-node involvement, tumor grade. Most common pT staging was noted to be pT3 and pN staging was pN0. Both POD 3 and 5 measurements of CEA, POD 5 measurements of CRP and PCT were found to be significantly elevated in patients who manifested an AL. CONCLUSIONS AND RELEVANCE The primary outcome was the ability of the said biomarkers in early prediction of leak leading to early drain removal in patients with a lower chance of AL. Drain tube CEA measurements on POD 3 and 5 were noted to be most accurate in prediction of early anastomotic leak as compared to Serum CRP and PCT and led to earlier drain removal in those patients in whom anastomotic leak had been ruled out.