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Showing 1-20 of 279 trials
NCT07583290
This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). Ulinastatin, a glycoprotein extracted from human urine, has shown potential benefits in reducing postoperative complications and inflammatory responses in cardiac surgery. However, evidence supporting its efficacy and optimal application in specific patient populations remains insufficient. This study will collect clinical data from approximately 4 tertiary cardiac centers in China, including patients who underwent cardiac surgery with CPB. Using machine learning algorithms (such as weighted K-modes clustering and XGBoost), the study aims to: (1) construct a multicenter real-world database for cardiac surgery; (2) identify clinical characteristics associated with ulinastatin treatment response; (3) develop and validate an AI-based risk stratification tool to assist clinical decision-making. This study may provide evidence-based guidance for personalized perioperative anti-inflammatory treatment in cardiac surgery.
NCT03974828
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.
NCT07573033
This randomized controlled trial evaluates the effectiveness of postoperative topical antibiotics compared with oral antibiotics in patients undergoing surgical extraction of impacted mandibular third molars. The study aims to compare postoperative outcomes including infection, dry socket, pain, swelling, recovery time, patient satisfaction, and adverse effects associated with antibiotic use. A total of 90 participants undergoing mandibular third molar surgery will be randomly assigned to receive either topical antibiotic application at the surgical site or a standard postoperative course of oral antibiotics. Participants will be followed for 14 days after surgery with clinical assessments conducted at scheduled follow-up visits. Detailed Description: Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications. This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment. A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol. All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes. The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy. Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.
NCT04663958
The term postoperative pulmonary complication is the development of any complications affecting the respiratory system after anesthetic and surgery procedures. The ARISCAT risk assessment score is a seven-variable regression model that divides patients into low, moderate, and high-risk groups. In this study, the investigators aimed to investigate the effectiveness of the ARISCAT risk scoring index in predicting postoperative pulmonary complication development in patients scheduled for major abdominal cancer surgery.
NCT07360691
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
NCT07537491
Perioperative complications following surgery for colorectal cancer (CRC) represent a major cause of postoperative morbidity and mortality. Existing risk stratification tools lack the precision to capture the complex biological and morphological factors that determine individual patient vulnerability. Artificial intelligence (AI)-based analysis of medical imaging data offers a promising approach to improve preoperative risk prediction. The KIA-Korekt study investigates whether perioperative complications in CRC patients can be predicted using multimodal AI-based image analysis. Three complementary imaging modalities are integrated: digital histopathology (haematoxylin-eosin whole-slide images, H\&E-WSIs), preoperative CT and MRI radiomics, and multiplex tissue imaging (mTI) including multiplex immunohistochemistry (mIHC) and imaging mass cytometry (IMC). The study includes a retrospective cohort of approximately 750 CRC patients treated between 2011 and 2021, and a prospective validation cohort of approximately 210 patients recruited from 2026 to 2028. Deep learning and radiomic feature extraction pipelines are applied to all modalities individually and in multimodal combination. Predicted outcomes include anastomotic leakage, wound infection, sepsis, ICU admission, and in-hospital mortality within 30 days of surgery. The study is conducted at the University Hospital Brandenburg, Brandenburg Medical School Theodor Fontane, in collaboration with the Department of Computational Pathology, TU Dresden.
NCT05788718
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: 1. Prescription pattern of sugammadex 2. 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.
NCT04879290
The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.
NCT05360069
With the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. Which stapler is more advantageous has not been determined. At present, the most commonly used is linear stapler or Circular stapler in esophagojejunostomy. However, there is still a lack of reliable evidence for the selection of the two staplers. The purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with gastric cancer who underwent total gastrectomy.
NCT06464978
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
NCT06430957
Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.
NCT03436238
The purpose of this multicentre, prospective, observational study is to identify robust biochemical markers that predict adverse cardiovascular outcomes and mortality in patients undergoing major abdominal surgery.
NCT05192837
Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption. Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups. Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.
NCT05703230
The current multicenter stepped wedge randomized cluster trial study aims to assess whether implementation of preoperative multidisciplinary team (MDT) discussions is (cost)effective for high risk noncardiac surgical patients. The main questions to answer are: * Primary question: Does implementation of preoperative multidisciplinary team discussions for high risk noncardiac surgical patients diminish serious adverse events as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment? * Secondary questions: Does implementation of preoperative multidisciplinary team discussion for high risk noncardiac surgical patients improve disability, survival, functional outcome, quality of life and cost-effectiveness as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment? Participants will be asked to answer questionnaires at baseline, 3, 6,9 and 12 months postoperatively or post MDT discussion. Patients for whom no structured preoperative multidisciplinary discussion is installed yet (care as usual) will be compared with patients for whom a structured preoperative multidisciplinary discussion is performed (intervention). The study will be performed in hospitals that have no established preoperative MDT meeting at the start of the study.
NCT04725916
This is a prospective randomized, controlled, unblinded, interventional feasibility study to evaluate if showering with post operative drains in place leads to an increase in complications. The patients included in the study will be those undergoing breast reductions and panniculectomies at Geisinger Medical Center. The patients will be randomized post operatively into one of two groups: 1) patients instructed to shower with drains in place, and 2) patients instructed not to shower while they have drains in place.
NCT07422441
People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.
NCT07411612
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days. In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.
NCT07409467
This prospective observational study aims to develop and evaluate predictive models for postoperative complications in patients aged 65 years or older scheduled for elective major surgery. The investigators will recruit 520 eligible patients visiting the preoperative assessment clinic. The study involves the prospective collection of comprehensive preoperative data using specific validated tools: * Physical Activity: Assessed using the Saltin-Grimby Physical Activity Scale (SGPAS) to categorize physical activity intensity. * Nutritional Risk: Screened using the Nutritional Risk Screening 2002 (NRS-2002) tool. * Psychological Status: Evaluated for anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). * Body Composition: Measured using a portable bioelectrical impedance analysis (BIA) device (BWA2.0S, InBody) to assess muscle mass, body fat/water, and phase angle. * Physical Function: Assessed via the short physical performance battery (SPPB) using electronic measurement devices (AndanteFit, DYPHI) to calculate frailty index and physical age. The primary endpoint is the occurrence and severity of postoperative complications within 30 days, evaluated using both the Clavien-Dindo Classification and the Comprehensive Complication Index (CCI). Using the collected dataset, the investigators will develop prediction models using both classical regression analysis and machine learning algorithms to compare their predictive performance.
NCT07408037
This study aims to evaluate the effect of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in children. The intervention includes games like ball blowing and bubble blowing. Anxiety is measured using the mYPAS-SF scale, and delirium is assessed with the PAED scale.
NCT07109505
Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.