Active clinical trials for "Postoperative Complications"

Surgical removal of impacted mandibular wisdom teeth is a frequent intervention, usually accompanied by unpleasant sequelae (pain, swelling and trismus) in the postoperative period, sometimes even with possibly serious complications (dry socket/alveolar osteitis and postoperative infection at the surgical site - SSI). It is therefore advisable to use various medications and procedures to prevent or alleviate the occurrence of these sequelae and complications. Accordingly, there is a debate in the literature on the expedience of perioperative (prophylactic) use of antibiotics. It is interesting that numerous articles recommending perioperative (prophylactic) antibiotic use to patients undergoing the impacted mandibular third molar surgery may be found, as well as those providing arguments for the disagreement with such an approach, considering that its benefits do not outweigh the risks of adverse side effects, especially due to growing resistance of microorganisms towards antibiotics, which is a possible serious threat to global health. Concerning the perioperative (prophylactic) use of antibiotics for this indication, consensus has not yet been reached, and neither of the views has been verified by convincing scientific evidence. Having the aforementioned dilemma in mind, the main endpoint of the study was to determine the validity of perioperative (prophylactic) use of antibiotics as to alleviate customary sequelae and possible complications after surgical removal of impacted mandibular third molars and, at the same time, the effectiveness of newer antibiotics (moxifloxacin and cefixime) when used for this purpose. Moreover, microbiological investigations of susceptibility of the isolated microorganisms to antibiotics used in this research were performed, which could verify the clinically obtained results. With this in mind, two major contributions, based on scientifically verified results, could be expected from the research: (1) confirmation or refuting the validity of perioperative (prophylactic) antibiotic use to control sequelae or complications that could follow the impacted mandibular third molar surgery; and (2) confirmation of the efficacy of fluoroquinolones (moxifloxacin) and cephalosporins (cefixime) in controlling odontogenic infections.

The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.

Background: Revisional bariatric surgery (RBS) represents a further solution for patients who experience an inadequate response following initial bariatric surgery or significant weight regain following an initial satisfactory response. Studies including the follow-up of patients with complications after RBS are still lacking. Aim: to analyze the trend, mortality, and complications at 30 days after RBS in Italy. Secondary aim: 30-day readmission rate, reoperations for any reason related to bariatric surgery. Design: longitudinal, prospective, multicenter study. Time interval: 10 months October 2021 - July 2022). Setting: 11 high-volume bariatric centers of the Italian National Health Service (SSN), university hospitals, hospitals, accredited private centers. Methods: All patients undergoing RBS from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering indications, technique, mortality, intraoperative and perioperative complications, readmission for any reason. All participating centers follow the same preoperative work-up protocol, indications, informed consent, and postoperative follow-up, including scheduled telephone and outpatient visits after 7, 15 and 30 postoperative days. Inclusion criteria: revisional procedures; no concomitant procedure, but hiatal hernia repair; age >18<60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Patients undergone RBS during 2016-2020 will be considered a control group. The study will not involve any modification of the usual protocols. Statistical analyze: to make qualitative quantitative comparison regarding clinical and anthropometric factors between the two study groups (2021-22; 2016-20), the z-test for two proportions and t-test (two-tailed) will be used, respectively. The significance is fixed at 0.05 and all analyzes will be performed with the SPSS v.27 software. Expected results: enroll about 500 patients to obtain information on the safety of RBS and the current trends in Italy.

Background: Literature often shows limited and discordant data regarding the prognostic value of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be worse in the elderly when compared with younger patients, and therefore gastrectomy with extended lymphadenectomy for non-early tumors is considered the "standard" surgical therapy for all of operable patients, despite any age- or comorbidity-related limitations. Recent trials reported a survival benefit for extended nodal dissection compared with the more limited method, but some Authors found age (and comorbidities) to be a relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself. Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All patients >75 years and with Charlson Comorbidity Score >5 with resectable M0 gastric cancer are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232 patients per group are necessary to achieve an 80% power to detect a 13% survival difference (from 56% to 69%) between groups. Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric cancer patients.

MAIN AIM OF THE STUDY To establish whether hemodynamic management guided by the hypotension prediction index (HPI) guided by the administration of intravenous fluids and vasoactive drugs in patients undergoing elective major abdominal surgery reduces the incidence of postoperative moderate-severe acute kidney injury (AKI) in the 30 days after surgery. STUDY DESIGN A low intervention level clinical, blinded, controlled, randomized, multicenter, with daily follow-up of patients until hospital discharge and of postoperative complications and mortality 30 days after surgery will be performed. This is a low-intervention clinical trial comparing standard treatments: The drugs used in the investigation are licensed. The drugs are used according to the indications contemplated in the technical data sheet and there are published scientific data on their efficacy and safety. The complementary diagnostic or follow-up procedures entail a very limited additional risk or burden to the safety of the subjects, which is minimal compared to that of standard clinical practice. STUDY DISEASE Intraoperative hemodynamic monitoring and management in surgical patients undergoing major abdominal surgery. STUDY POPULATION AND TOTAL NUMBER OF PATIENTS The sample of this study consists of patients of both genders, aged over 65 years and/or physical status ASA III or IV, undergoing elective major abdominal surgery (abdominal, urological, gynecological) under general/combined anesthesia (using laparoscopic or open approaches. To detect a 5% absolute reduction (from 10% to 5%) in the primary outcome variable (postoperative AKI up to 30 days) with a sample size ratio of 1%, and an overall type I error rate of 5%, we need 870 patients (435 per arm). Assuming a 10% loss rate, the total amounts to 958 patients, 479 for each group. DURATION OF THE STUDY The total planned duration of the overall study, which includes authorization, recruitment of subjects, and follow-up of subjects until completion of the analysis of the results obtained, is 19 months.

Postoperative adverse events may be associated with substantial morbidity and mortality. However, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. In 2004, the Clavien-Dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations. Despite the appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. In a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by Dindo et al. Especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Patients have to face with perioperative sleep disorders, and this situation can continue for a long time after surgery. Anesthetic agents may cause sleep disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency and poor sleep quality. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high. The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.

The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

The purpose of this observational study is to evaluate patients who are planning to administer sugammadex after rocuronium or vecuronium is used. The main questions it aims to answer are: Prescription pattern of sugammadex Effectiveness and safety of sugammadex Since this study is observational, only data generated under daily treatment are to be collected, and no additional tests or drug administration is conducted for the study. The patients are observed from baseline to 24 hours after the initial administration of sugammadex.