METHODS: Patients undergoing elective midline laparotomy through standardized incisions in two tertiary hospitals from February 2017 to September 2018 were randomized to either LS or SS. The primary outcome was post-operative patient-controlled analgesia morphine usage at 24 h. Secondary outcomes were presence of surgical site infection and length of hospital stay (LOHS). Categorical variables were analysed using chi-squared analysis. Outcomes of study were tested for normal distribution. Skewed data were analysed using Mann-Whitney U-test.
RESULTS: Eighty-six patients were recruited (42 SS and 44 LS). The median age was 66 (interquartile range (IQR) 15). Majority were males (62.8%) and Chinese (50%). The median incision length was 17 cm in both groups. The median patient-controlled analgesia morphine usage 24 h post-operatively did not differ significantly (SS 21 mg, IQR 28.3; LS 18.5 mg, IQR 33.8, P = 0.829). The median pain score at rest (SS 1, IQR 1; LS 1, IQR 2, P = 0.426) and movement (SS 3, IQR 1; LS 3, IQR 2, P = 0.307) did not differ significantly. LOHS was shorter in the SS group (SS 6, IQR 4; LS 8, IQR 5, P = 0.034). The rate of surgical site infection trended lower in the SS group with no statistical difference.
CONCLUSION: There were no differences in post-operative pain between SS and LS but we found that there were shorter LOHS in SS arm as secondary outcome.
METHODS: This was a randomized, double-blind, controlled study of 66 eligible neonates with PICCs inserted for the administration of TPN. Infants were randomized to receive TPN containing either 1 IU ml(-1) of heparin (n = 35) or no heparin (n = 31).
RESULTS: There was no significant difference in the incidence of blocked catheters between the two groups of infants (heparin: 14.3%; no-heparin: 22.6%, p = 0.4). Although a higher percentage (62.9%) of infants in the heparin group received a complete course of TPN successfully via PICC than those in the no-heparin group (48.4%), the difference was not statistically significant (p = 0.3). There were no significant differences in the incidence of catheter-related sepsis, hypertriglyceridaemia, hyperbilirubinaemia, coagulopathy or intraventricular haemorrhage between the two groups.
CONCLUSION: Addition of heparin to TPN fluid was not associated with a significant reduction in the incidence of blocked PICCs. However, the sample size of this study was too small to exclude even rather marked differences between the groups.
AIM: To investigate the efficacy and tolerability of mixed soluble/insoluble fibre vs. psyllium in a randomized double-blind controlled trial.
METHODS: Constipated patients (Rome III) received mixed fibre or psyllium, 5 g b.d., for 4 weeks. Daily symptoms and stool habit were assessed using stool diary. Subjects with ≥1 complete spontaneous bowel movement/week above baseline for ≥2/4 weeks were considered responders. Secondary outcome measures included stool consistency, bowel satisfaction, straining, gas, bloating, taste, dissolvability and quality of life (QoL).
RESULTS: Seventy-two subjects (mixed fibre = 40; psyllium = 32) were enrolled and two from psyllium group withdrew. The mean complete spontaneous bowel movement/week increased with both mixed fibre (P < 0.0001) and psyllium (P = 0.0002) without group difference. There were 30 (75%) responders with mixed fibre and 24 (75%) with psyllium (P = 0.9). Stool consistency increased (P = 0.04), straining (P = 0.006) and bloating scores decreased (P = 0.02) without group differences. Significantly more patients reported improvement in flatulence (53% vs. 25%, P = 0.01) and felt that mixed fibre dissolved better (P = 0.02) compared to psyllium. QoL improved (P = 0.0125) with both treatments without group differences.
CONCLUSIONS: Mixed fibre and psyllium were equally efficacious in improving constipation and QoL. Mixed fibre was more effective in relieving flatulence, bloating and dissolved better. Mixed fibre is effective and well tolerated.
DESIGN: Double-blind, placebo-controlled, multicenter randomized trial.
SETTING: Tertiary care hospitals.
INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours.
MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.
CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.
METHODS: TIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events.
RESULTS: The study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk.
CONCLUSION: Results of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.
OBJECTIVE: To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.
METHODS: A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.
RESULTS: A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
STUDY LIMITATION: Skin hydration was not evaluated.
CONCLUSION: Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.