ABSTRACT
BACKGROUND: Dry mouth is a common perioperative patient complaint. There are a number of treatments used for dry mouth in other settings which are effective. None have been tested previously in the perioperative setting. Interventions to Manage Dry mouth (IM DRY) compared the effect of water and a saliva substitute on mouth dryness. The primary objective was to demonstrate the feasibility of conducting a large randomised controlled trial and secondary scientific aims were to assess treatment potential efficacy. METHODS: Single blind, pilot randomised controlled trial (RCT) of 101 pre-operative elective surgical patients who were randomised to water or saliva substitute (Biotene oral rinse, GlaxoSmithKline, Australia) at a tertiary, university hospital. Dry mouth was assessed by 100 mm visual analogue scale (VAS) and 5-point Likert score. RESULTS: One hundred participants completed follow-up and comprised the analysis dataset. All feasibility outcomes were achieved (recruitment rate > 5 participants a week, >95% completeness of the dataset, study protocol acceptability to staff, acceptability to participants > 66% and adherence to time limits within the protocol). Mean recruitment rate was 6 participants per week. These data were 99% complete. There were no adverse side effects or complications noted. There were no concerns raised by staff regarding acceptability. Overall, there was a mean of 30 min (± SD 5 min) between delivery of the intervention and the assessment, 30 min being the target time. The difference in VAS post intervention was - 11.2 mm (95% CI - 17.3 to - 5.1 mm) for water and - 12.7 mm (95% CI - 18.7 to - 6.7 mm) for saliva substitute. The proportion of patients who had improved dry mouth increased from 52% for water to 62% for saliva substitute. CONCLUSIONS: IM DRY successfully achieved its primary feasibility aims: recruitment rate, completeness of these, acceptability and protocol adherence. Saliva substitutes, used in the perioperative management of dry mouth, may be a simple, inexpensive, and low risk solution to help alleviate this common complaint. A large randomised controlled trial is feasible and is currently recruiting (ANZCTR 12619000132145). ETHICS AND TRIAL REGISTRATION: Northern A New Zealand Health and Disability Ethics Committee (reference 17/NTA/152). Australian New Zealand Clinical Trials Registry (Number: 12618001270202). Registered retrospectively 18 October 2018.
ABSTRACT
AIM: To assess the incidence of pre-operative anaemia in patients presenting for general surgery and determine the relationship between pre-operative anaemia, transfusion and post-operative metrics including length of stay (LOS) and infectious complications. METHOD: A retrospective cohort of 1,186 patients. Stratification into two groups with and without pre-operative anaemia through propensity score matching. Logistic regression was used to determine the relationship between pre-operative anaemia, blood transfusion and infectious complications. RESULTS: The incidence of pre-operative anaemia was 17.4%. Red blood cell (RBC) transfusion was greater in those with PA than those without, 13.1% versus 0.7% (OR 21.7 (2.9-166.7, p<0.001)). In the propensity matched cohort, pre-operative anaemia was associated with an increase in LOS from 2.1 to 3.0 days (p=0.006) and increased infectious complications from 6.4% to 18.4%, (OR 3.3 (1.4-7.7), p=0.004). The risk of infectious complications was amplified in the patients receiving RBC transfusion. After adjustment for transfusion, in patients with pre-operative anaemia the OR for infectious complications became 2.3 (0.95-5.7, p=0.06) for those not transfused and 5.5 (2.0-15.3, p=0.001) for those transfused. CONCLUSION: Pre-operative anaemia is associated with an increase in hospital LOS and infectious complications. When adjusted for transfusion the effect of pre-operative anaemia alone on hospital LOS and infectious complications is not statistically significant. Expeditious investigation and treatment of PA could reduce complications and save resources.