Pharyngocutaneous Fistula Following Primary Total Laryngectomy: a Meta-analysis

Pharyngocutaneous fistula (PCF) is the most common complication which significantly increases morbidity. High-level evidence is lacking that determines the PCF rates in the primary laryngectomy. The main objective of this study was to systematically identify the factors leading to the PCF formation in primary laryngectomy. Human studies reporting at least one risk factor for developing PCF in patients undergoing primary total laryngectomy for laryngeal cancer were included. PubMed, EMBASE, and Cochrane databases were searched for the data extraction. Risk of bias assessment tool for non-randomized trial tool was used. Cochrane's Q test and Higgin's I-2-heterogeneity was applied. The Mantel-Haenszel and DerSimonian Laird method was employed. Odds ratio was calculated for each risk factor, a P-value < 0.05 was considered as statistically significant. PROSPERO registration CRD42021248382. The meta-analysis comprised a total of 2446 patients in 14 included non-randomized studies. The among the analyzed risk factors-comorbidities (OR 2.781, R: 1.892-4.088, P < 0.001), site of tumor (OR 4.485, R: 3.003-6.699, P < 0.001), low pre-operative hemoglobin (OR 3.590, R: 2.130-6.050, P < 0.001), low pre-operative albumin (OR 2.833, R: 1.596-5.031, P < 0.001), utilization of surgical staplers (OR 0.172, R: 0.064-0.460, P < 0.001) (protective effect), positive mucosal margin (OR 4.92 R: 1.90-12.75, P = 0.001). The risk factors for PCF in patients undergoing primary TL included comorbidities, hypopharyngeal involvement, pre-operative hemoglobin and albumin, stapler usage, and positive mucosal margin. Level of Evidence - III