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Surgery clinical trials

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NCT ID: NCT05851534 Not yet recruiting - Surgery Clinical Trials

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

PROMISE-P
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The goal of this stepped-wedge randomized controlled trial is to investigate whether implementation of a best practice program for preoperative optimisation (prehabilitation program) with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors in patients with (suspected) pancreatic cancer will improve outcome. The main questions it will aim to answer are: 1. Does a prehabilitation program improve the time to functional recovery after pancreatic surgery? 2. Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?

NCT ID: NCT05834049 Not yet recruiting - Anxiety Clinical Trials

Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Start date: July 1, 2025
Phase: N/A
Study type: Interventional

This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.

NCT ID: NCT05819801 Not yet recruiting - Surgery Clinical Trials

Effect of Fasting on Patient Outcomes After Wide-Awake, Local Anesthesia-only, No Tourniquet (WALANT) Procedures

Start date: February 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether eating solid food prior to undergoing a wide awake local-only no tourniquet (WALANT) procedure reduces anxiety in patients or has any effect on outcomes. Patients will be split randomly into two groups and told whether to eat or fast before their procedure. We will then compare levels of anxiety and nausea on the day of the procedure as well as satisfaction with the procedure and other outcome measures at follow-up visits. Our hypothesis is that patients who are instructed to eat before their WALANT procedure will have less anxiety, nausea, and overall higher satisfaction compared to those who are instructed to fast prior to their procedure.

NCT ID: NCT05810792 Not yet recruiting - Pancreatic Cancer Clinical Trials

Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer

PANCEP-1
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

A key aspect of the trial is that functions of anti-neoplastic T cells and natural killer (NK) cells, may be inhibited by immunosuppressive signals from myeloid cells, in particular reactive oxygen species (ROS) produced by several subsets of myeloid cells. In cancer, such immunosuppressive cells are commonly denoted myeloid-derived suppressor cells (MDSCs), which are immature monocytes and granulocytes that impede immune-mediated clearance of malignant cells by multiple mechanisms, including the formation of immunosuppressive ROS via myeloid cell NADPH oxidase (NOX2). The presence of MDSCs within or adjacent to tumor tissue is assumed to facilitate the growth and spread of tumors and may also dampen the efficacy of cancer immunotherapies. The underlying hypothesis for this clinical trial is the administration of HDC/IL-2 will reduce surgery-induced inflammation and reduce metastasis. A phase I/II open label, single-center study of the safety, tolerability, and efficacy of peri- and postoperative therapy with histamine dihydrochloride and low-dose interleukin-2 treatment in subjects with primary pancreatic cancer.To assess the frequency and extent of adverse events associated with low dose interleukin-2 and histamine dihydrochloride when used as perioperative therapy.To determine progression free survival and overall survival following surgery, and compare with matched historical controls from the Swedish Cancer Registry.

NCT ID: NCT05797064 Not yet recruiting - Surgery Clinical Trials

Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning

Start date: June 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.

NCT ID: NCT05796830 Not yet recruiting - Quality of Life Clinical Trials

Determination of the Effect of Puzzle Use in Elderly Patients

Start date: March 28, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effects of the use of a simple, reliable and cost-effective puzzle on post-operative cognitive function changes, postoperative recovery, and quality of life using questionnaires and face-to-face interview techniques.

NCT ID: NCT05772819 Not yet recruiting - Surgery Clinical Trials

'Cardiac and Intramuscular Adaptations Following Short-term Exercise Prehabilitation in Unfit Patients Scheduled to Undergo Hepatic- or Pancreatic Surgery'

CIRCULATE
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Surgery remains an important treatment modality in the treatment of hepatopancreatobiliary (HPB) malignancies, but the physiological stress caused by surgery is at the same time a challenge for the homeostasis of patients. A patient's preoperative aerobic capacity has been found to have a consistent relation with postoperative outcomes in major abdominal surgery, with low aerobic capacity being associated with a higher risk of postoperative morbidity and mortality. Preoperative exercise prehabilitation programs can effectively increase the ability of patients to cope with surgical-induced allostatic load, by improving aerobic capacity, and functioning of the respiratory, cardiovascular, and/or musculoskeletal systems. However, besides the effect of exercise prehabilitation on physical fitness in terms of improvement of aerobic capacity as measured by the cardiopulmonary exercise test (CPET), the exact role of adaptations in cardiac and/or skeletal muscle function contributing to the improvement in aerobic capacity is still unknown. Insight in the physiological adaptations that lead to improvement in aerobic capacity after prehabilitation in patients with low aerobic capacity will enable caregivers to individually optimize the exercise program (e.g. by changing exercise frequency, intensity, duration and type) and better explain the rationale and effectiveness behind the short-term physical exercise training program to patients. Therefore, the main objective of this study is to assess the central (cardiac function) and peripheral (skeletal muscle function) physiological adaptations in response to short-term exercise prehabilitation. Secondary objective is to assess the relationship between immune function and exercise. In this study, unfit patients are asked to undergo additional in-magnet exercise testing to investigate the central and peripheral physiological adaptations in response to exercise prehabilitation.

NCT ID: NCT05748964 Not yet recruiting - Surgery Clinical Trials

Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

NCT ID: NCT05744219 Not yet recruiting - Surgery Clinical Trials

Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

IRIS
Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion. Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study. By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo. The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb <80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio. The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (<400 ml), high (400-4000 ml) and very high (>4000 ml) per-operative blood loss. Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.

NCT ID: NCT05709041 Not yet recruiting - Obesity Clinical Trials

Effect of Transpulmonary Pressure Guided Ventilation on Intraoperative Right Heart Function

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings. Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs. For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded. For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery. A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed. Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.