A Randomised Double-Blind Multicentre Placebo-Controlled Study to Investigate the Effect of Ranitidine on the Post-Operative Infection Rate and Survival Rate of Patients Undergoing Surgery for Colorectal Cancer
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ABSTRACT:
DISEASE(S): Rectum,Colon
PROVIDER: 2410830 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:BackgroundNon-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population.Methods and findingsA total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events.ConclusionsPerioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient's decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption.Trial registrationEU Clinical Trials Register 2011-005007-33.
| S-EPMC4859493 | biostudies-literature
Project description:Propolis is a potent anti-microbial and natural anti-inflammatory by-product obtained from the beehive. Studies have demonstrated the superior biocompatibility and anti-microbial properties of propolis as compared to calcium hydroxide. However, its effect on postoperative endodontic pain is unknown. Therefore, this study aimed to investigate the impact of Chinese propolis paste as an intracanal medicament on postoperative endodontic pain intensities compared with calcium hydroxide (control) at different time intervals in necrotic teeth with periapical radiolucency. Eighty patients with single-rooted necrotic teeth with visible periapical radiolucency were recruited and randomly allocated to either the calcium hydroxide or propolis groups. After chemo-mechanical preparation and intracanal medicament insertion, patients were given the VAS (visual analogue scale) to record pain scores. Inter-group data were compared and analyzed using two-way repeated measure ANOVA (Bonferroni test). A p-value of < 0.025 was considered significant. In total, >78% of the patients experienced no or only mild post-operative pain in both the groups at all time intervals, without any significant difference in pain scores between the two groups (p > 0.025). An overall flare-up rate of 14.8% was found. The results suggest that either of these medicaments can be used as an inter-appointment medication for the prevention of postoperative pain in necrotic cases.
| S-EPMC7014406 | biostudies-literature
Project description:IntroductionDual antiplatelet therapy (DAPT), referred to as the combination of aspirin and P2Y12 receptor antagonist (clopidogrel or ticagrelor), potentially improves patency of saphenous vein grafts (SVG) after coronary artery bypass grafting (CABG), while it is further proposed that DAPT potentially increases bleeding risk. Compared with DAPT, de-escalated DAPT (De-DAPT) is an effective antiplatelet strategy for acute coronary syndrome treatment, which significantly reduces the risk of bleeding without increasing the incidence of major adverse cardiovascular events. However, insufficient evidence is available to determine the timing of DAPT after CABG.Methods and analysisETHICS AND DISSEMINATION: The Ethics Committee in Fuwai hospital approved this study (2022-1774). Fifteen centres agreed to participate the TOP-CABG trial, and the study has been approved in these 15 centres by whose ethics committee. The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT05380063.
| S-EPMC10314523 | biostudies-literature
Project description:Systemic lidocaine can provide satisfactory post-operative analgesia in adults. In this study, we assessed whether intravenous lidocaine is effective for post-operative analgesia and recovery in children undergoing laparoscopic inguinal hernia repair. A total of 66 children aged from six months to less than six years were classified in either the lidocaine (L) or control (C) groups. Children in Group L received a lidocaine infusion (a bolus dose of 1 mL kg-1, followed by a 1.5 mg kg-1 h-1 infusion), whereas Group C received the same volume of 0.9% saline. The primary outcome was the number of patients who presented face, legs, activity, crying and consolability (FLACC) scores of four or more, and therefore received rescue analgesia in the post-anesthesia recovery care unit (PACU). Secondary outcomes included the highest FLACC score in the PACU, FLACC, and the parents' postoperative pain measure (PPPM) score at 48 h post-operation, as well as side effects. The number of children who received rescue analgesia in the PACU was 15 (50%) in Group L and 22 (73%) in Group C (p = 0.063). However, the highest FLACC score in PACU was lower in Group L (3.8 ± 2.4) than in Group C (5.3 ± 2.7) (p = 0.029). In conclusion, systemic lidocaine did not reduce the number of children who received rescue analgesia in PACU.
| S-EPMC6912688 | biostudies-literature
Project description:The management of end stage heart failure has changed dramatically in recent years with the advent of mechanical circulatory support devices as well as rapid improvement and increased availability of these devices. With the improvements in survival and quality of life in these patients, post-operative infections become a significant contribution to morbidity and mortality. Post-operative infections need to be adequately addressed in a timely fashion by early diagnosis and appropriate treatment. Recognizing risk factors for infection and instituting good infection control measures is also key in caring for these patients. Multiple patient and device factors have been shown to be correlated with increased post-operative infections, and cellular immunity is also impaired in patients on ventricular assist devices (VAD). Cultures should be taken prior to starting antimicrobial treatment. Empirical treatment needs to account for common pathogens, local microbial resistance and subsequently be culture guided once results are available. Patients on extracorporeal membrane oxygenation present a unique challenge with drug dosing due to altered pharmacokinetics. VAD related and VAD specific infections require appropriate wound care and possible surgical intervention. This narrative review summarizes the literature available for the management and prevention of post-operative infections in patients with mechanical circulatory devices. Vigilance in identifying risk factors, prompt treatment and active prevention is crucial to the management.
| S-EPMC7396248 | biostudies-literature
Project description:INTRODUCTION:Psoriasis vulgaris is a common skin disease that is characterised by persistent localised erythematous scaly plaques. Yinxieling is a Chinese herbal formula for psoriasis that has been used for more than 20 years in China. To facilitate application, PSORI-CM01 was developed based on the optimisation and simplification of Yinxieling tablets performed in a previous study and in clinical practice. However, the scientific evidence regarding whether PSORI-CM01 is more effective for psoriasis than the original Yinxieling remains insufficient. Therefore, we designed a randomised clinical trial to investigate the effect, safety and cost-effectiveness of PSORI-CM01 granules compared with those of Yinxieling tablets for the treatment of patients with psoriasis. METHODS AND ANALYSIS:This ongoing study is a two-arm parallel, randomised, double-blind, double-dummy clinical trial. Five hundred and fifty-six participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Participants in PSORI-CM01 group will receive a 5.5?g granule of PSORI-CM01 two times daily and five placebo tablets three times daily for 12 weeks. The participants in the Yinxieling group will receive five Yinxieling tablets three times daily and a placebo granule two times daily for 12 weeks. The primary outcome is the reduction of the Psoriasis Area and Severity Index. The secondary outcomes include relapse rate, Visual Analogue Scale scores, body surface area and the Dermatology Life Quality Index. Cost-effectiveness analysis will be performed from a health and community care provider perspective. ETHICS AND DISSEMINATION:This research protocol had been reviewed and approved by the institutional review boards of three trial centres (Guangdong Provincial Hospital of Chinese Medicine (B2014-026-01), Affiliated Hospital of Tianjin Chinese Medicine Academy (2014-KY-001) and Third Hospital of Hangzhou (B2014-026-01)). The findings will be disseminated to the public through conference presentations and open-access journals. TRIAL REGISTRATION NUMBER:Chinese Clinical Trial Registry (ChiCTR-TRC-14005185); Pre-results.
| S-EPMC5695474 | biostudies-other
Project description:One hundred patients undergoing abdominal surgery were included in this prospective study. The role of local application of Betadine, use of synthetic sutures, and use of low pressure subcutaneous suction drainage were evaluated in preventing post-operative wound infection. The infection rate was 15 per cent with Betadine, 15.4 per cent with prolene, 20 per cent with subcutaneous suction drainage and 30.8 per cent in the control group.
| S-EPMC5530275 | biostudies-other
Project description:No description or hypothesis / outcomes information provided at time of study registration
| 2425922 | ecrin-mdr-crc
Project description:ObjectivesThis study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.DesignFIDELITY post hoc analysis; median follow-up of 3 years.SettingFIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.ParticipantsAdults with type 2 diabetes and chronic kidney disease receiving optimised renin-angiotensin system inhibitors (N=13 026).InterventionsRandomised 1:1; finerenone or placebo.Primary and secondary outcome measuresCardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.ResultsMean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged <65, 65-74 and ≥75 years, respectively; 69.8% were male. Cardiovascular benefits of finerenone versus placebo were consistent across age (HR 0.94 (95% CI 0.81 to 1.10) (<65 years), HR 0.84 (95% CI 0.73 to 0.98) (65-74 years), HR 0.80 (95% CI 0.65 to 0.99) (≥75 years); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65-74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.ConclusionsFinerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.Trial registration numbersNCT02540993, NCT02545049.
| S-EPMC10952937 | biostudies-literature
Project description:The aim of this retrospective study was to identify the significant risk factors that contribute towards postoperative infection in patients recovering from orthognathic surgery.Retrospective records of 522 patients who underwent orthognathic surgery over 9 year period were evaluated for postoperative infection within 3 months of surgery and after 3 months of surgery. The variables of interest included age, gender, habits like smoking and alcohol consumption and incidence of postoperative infection.The overall infection rate was 4.60%. Patients who underwent bilateral sagittal split osteotomy to advance the mandible had an infection rate of 10.4%. Statistically significant predictor variables (P < 0.05) included patients who had the smoking habit, and those that received bone grafts in both the time periods.In conclusion, the occurrence of infection after orthognathic surgery is influenced by multiple factors, among which are the type of osteotomy, smoking habit and bone grafting procedures.
| S-EPMC5493556 | biostudies-literature