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Postoperative Complications clinical trials

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NCT ID: NCT05556174 Recruiting - Clinical trials for Postoperative Complications

Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

REMAIN-1
Start date: October 9, 2022
Phase: N/A
Study type: Interventional

Postoperative Pulmonary Complications (PPC) are common. It severely affects postoperative recovery, particularly in abdominal surgery. Several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. Other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. The purpose of this study was to compare the effects of the above two regimens on postoperative pulmonary complications.

NCT ID: NCT05496322 Recruiting - Clinical trials for Postoperative Complications

Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure

NiMon
Start date: January 26, 2023
Phase: N/A
Study type: Interventional

Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question

NCT ID: NCT05491434 Recruiting - Sarcopenia Clinical Trials

Sarcopenia in Colorectal Cancer Patients, Intervention Study

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases. The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.

NCT ID: NCT05489757 Recruiting - Clinical trials for Complication of Surgical Procedure

Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery

SPY Q-ICG PAS
Start date: February 16, 2022
Phase: N/A
Study type: Interventional

The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation between AL and shorter disease-free survival in colorectal surgery. Despite its multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally, perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis and bleeding from the resection lines. However, these clinical parameters are not able to reliably assess the real visceral perfusion and their evaluation is limited in minimally invasive surgery. Hence, the growing interest for innovative techniques able to properly assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine green (ICG) has become increasingly popular during the last decade, although its approval for biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent properties, it allows the real-time visualization of tissue vascularization. FA with ICG has shown promising results for the evaluation of perfusion in numerous surgical procedures, thus leading to modifications of the surgical strategy and consequently to a decrease in the rates of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of fluorescence performed by the operating surgeon. These results lack into a high inter-observer variability and affect the possibility to obtain objective, reproducible and reliable tissue perfusion assessments. Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and values can be extracted. Given the power of ICG in reflecting the perfusion of examined tissues, a new quantification algorithm has the potential to turn the subjective parameters derived from surgeon's perspective into objective numeric values. The primary aim of this study is to evaluate which Q-ICG values provided by a new quantification algorithm correspond to subjective perfusion parameters usually evaluated by the surgeon in patients undergoing left colon, rectal or esophagogastric resections. The secondary aim is to evaluate possible correlations between Q-ICG values provided by the quantification algorithm and perioperative outcomes.

NCT ID: NCT05479825 Recruiting - Clinical trials for Postoperative Complications

Tubeless Intersegmentectomy Plane Identification With Fluorography

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic). Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.

NCT ID: NCT05418881 Recruiting - Surgery Clinical Trials

Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)

MONITOR
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.

NCT ID: NCT05416411 Recruiting - Clinical trials for Postoperative Complications

Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery

RESMOB
Start date: July 20, 2022
Phase: N/A
Study type: Interventional

Postoperative pulmonary complications (PPCs) are the most frequent complications occurring in patients undergoing thoracic surgery and they are associated with prolonged hospital stay, decreased survival and expanding medical costs. Implementation of structured and supervised exercise programs including endurance training (ET), respiratory muscle training (RMT) or a combination of both, within the short waiting period before surgery, has been shown to enhance patients' physical fitness, to provide protective effects against PPCs and therefore to spare health care resources by shortening intensive care unit (ICU) and hospital lengths of stay. More recently, a simple intervention consisting in patient's instruction and education about modifiable risk factors, optimal breathing pattern and the impact of physical exercise has emerged as a simple alternative intervention prevent PPCs, although the evidence is inconclusive. Therefore, the investigators propose a multicentre randomized, open, blinded end point controlled trial testing the hypothesis that preoperative education and instruction focused on breathing exercise and endurance training reduce the occurrence of PPCs in patients undergoing thoracic or abdominal surgery. Patients with Intermediate-to-high risks factors for PPCs will be randomized on a 1:1 basis into an intervention arm and a usual care arm (Control group). In the Education group, patients will be asked to use a flow resistive device (One set of 30 repetitions, two times a day and to increase their daily physical activities (> 5'000 steps or equivalent) until surgery. Primary study endpoint will be the incidence of PPCs (e.g., atelectasis, pneumonia, respiratory failure) according to the European Perioperative Clinical Outcome definitions. Secondary outcomes will include non-respiratory complications, utilization of hospital resources (e.g., hospital length of stay, ICU admission),and preoperative changes in maximal inspiratory pressure [MIP]. Assuming a rate of 39% PPCs in the controls and a possible reduction to 26% in the intervention group, enrollment of 203 patients per group will provide 80% power with an alpha value of 0.05. Taking into account dropouts (5%) and in-hospital mortality rate (2%), a total of 436 surgical patients will be enrolled.

NCT ID: NCT05404503 Recruiting - Clinical trials for Incidence of Cholangiocarcinoma on Choledochal Cysts

Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center

QuiCo
Start date: October 2022
Phase:
Study type: Observational

Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Globally, they account for 1% of all biliary pathology benign, with a clearly higher incidence in Asian countries (1/5,000 in China, 1/1,000 in Japan, compared to 1/100,000-150,000 in Western countries). However, the number of adults diagnosed in recent years has increased by up to 70% due to improvements in imaging tests. Currently, the common bile duct malformation is considered a premalignant entity: although the data are not very precise, it is estimated that between 2.6% and 26% of patients diagnosed choledochal cyst, will develop cholangiocarcinoma. In this sense, we must bear in mind that most of the published literature is of Asian origin, where the rate of cholangiocarcinoma is 0.1-71/100,000 compared to 0.1-1.8/100,000 in Europe or 0.6-1/100,000 in the USA. The most used classification to differentiate the types of cysts is that of Todani. Following this classification, we would find a higher rate of malignancy on types I and IV. The recommendations found in the literature refer to the need for surgical intervention for choledochal cysts due to their high rate of malignancy. These recommendations are based on studies conducted in a symptomatic Asian population. We do not usually find in therapeutic algorithms the inclusion of various factors that could be involved in the development of malignancy such as episodes of cholangitis, presence of anomaly in the pancreatobiliary junction, presence of lithiasis in cystic dilatation, etc. Some surveys carried out among the scientific population reflect a lack of consensus on its management: in the same clinical situation, different surgery units specialized in hepatobiliary-pancreatic pathology would act in the opposite way (specifically surgical versus conservative treatment). Bile duct resection is not without complications, both short-term and long-term. Therefore, the patient's symptoms, age or comorbidities can play an important role in decision-making in the treatment of this pathology. This nationwide multicenter retrospective observational study aims to determine the clinical situation of this rare pathology in a Western environment. A retrospective analysis of patients diagnosed with choledochal cyst in the period between 2000 and 2020 is proposed. Demographic variables, risk factors for cholangiocarcinoma, symptoms associated with the cyst and its characteristics, diagnostic method, type of treatment, complications will be analyzed. Malignancy, time, and follow-up method will also be discussed. This study will attempt to answer questions about the incidence of choledochal cysts in our environment, their association with cholangiocarcinoma, the associated morbidity and mortality, as well as the therapeutic and follow-up attitudes adopted in the face of this rare pathology.

NCT ID: NCT05401877 Recruiting - Breast Cancer Clinical Trials

Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

Start date: May 1, 2021
Phase:
Study type: Observational

Breast cancer patients who had undergone surgery, chemotherapy and radiotherapy suffered from complications, including shoulder stiffness, lymphedema and scar contracture. These symptoms impaired one's ADL function. Rehabilitation may relieved symptoms. However, it is difficult to estimate how long one should receive rehabilitation. The study is trying to establish a machine-learning based model in order to predict the period of rehabilitation.

NCT ID: NCT05392426 Recruiting - Clinical trials for Postoperative Complications

Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury

Start date: May 30, 2022
Phase:
Study type: Observational

To use left ventricular global longitudinal strain as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. The study was designed according to a prospective follow-up cohort.