Meta-analysis on the rate of pharyngocutaneous fistula in early oral feeding in laryngectomy patients.

BACKGROUND: Laryngectomy remains a common operation in head and neck units. The operation holds significant risk of post-operative morbidity including swallowing dysfunction. The most significant post-operative concern is the formation of a pharyngocutaneous fistula [PCF], the reported incidence of which is between 3% and 65%. The purpose of this systematic review and meta-analysis was to assess the safety of initiating early oral feeding following laryngectomy and the risk of PCF formation. METHODS: A literature search was conducted through online databases: MEDLINE, EMBASE and PubMed. Eligible studies were included which contained cohorts of patients who had undergone laryngectomy, with early oral feeding commencing within seven days compared to late oral feeding. The primary outcome assessed was the incidence of PCF. Studies were excluded if cohorts had not included laryngectomy or if no comment was made on PCF formation. Meta-analysis was used to examine associations between oral feeding and PCF formation using Fixed Effect models. RESULTS: Twelve studies and 1883 patients were included after systematic review. Six studies were non-interventional whereas the remaining were randomized clinical trials. Exposure included those with early oral feeding (before seven days) or late feeding oral feeding (after seven days) and the outcome assessed was the risk of PCF formation. Results from observational studies showed a higher risk of PCF formation for early feeders compared to late feeders [RR = 1.56, 95% CI: 1.15, 2.11]. Higher risk was also observed for RCT but was not significant [RR = 1.40, 95% CI: 0.85, 2.30]. Overall, there was a 50% greater risk of PCF formation for early oral feeding compared to late oral feeding [RR = 1.51, 95% CI: 1.17, 1.96]. CONCLUSION: While early oral feeding can reduce post-laryngectomy patients' hospital stay and improve psychological wellbeing, there is a significant relative risk of PCF development within this group. However, this must be taken in context of the significant heterogeneity that exists within the literature.

A Non-inferiority Trial: Safety and Efficacy of Topical 1:1000 versus 1:10 000 Epinephrine in Sino-nasal Surgeries.

OBJECTIVE: This study aimed to test the non-inferiority of topical 1:1000 epinephrine compared to topical 1:10 000 with regard to intraoperative hemodynamic stability, and to determine whether it produced superior visibility conditions. METHODS: A single-blinded, prospective, cross-over non-inferiority trial was performed. Topical 1:1000 or topical 1:10 000 was placed in 1 nasal passage. Hemodynamic parameters (heart rate, systolic and diastolic blood pressures, and mean arterial pressure) were measured prior to insertion then every minute for 10 minutes. This was repeated in the contralateral nasal passage of the same patient with the alternate concentration. The surgeon graded the visualization of each passage using the Boezaart Scale. The medians of the greatest absolute change in parameters were compared using a Wilcoxon Rank-Signed test and confidence intervals were calculated using a Hodges-Lehman test. The non-inferiority margin was pre-determined at 10 bpm for heart rate and 10 mmHg for blood pressures. A Wilcoxon Rank-Signed test was used to assess superiority in visualization. RESULTS: Thirty-two patients were enrolled and after exclusions, nineteen were assessed (mean age = 35.63 ± 12.49). Differences in means of greatest absolute change between the 2 concentrations were calculated (heart rate = 2.49 ± 1.20; systolic = -1.51 ± 2.16; diastolic = 2.47 ± 1.47; mean arterial pressure = 0.07 ± 1.83). In analyses of medians, 1:1000 was non-inferior to the 1:10 000. There was a significant difference (-0.58 ± 0.84; P = .012) in visualization in favor of topical 1:1000. CONCLUSION: Topical 1:1000 epinephrine provides no worse intraoperative hemodynamic stability compared to topical 1:10 000 but affords superior visualization and should be used to optimize surgical conditions.