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Surgery clinical trials

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NCT ID: NCT06189131 Recruiting - Surgery Clinical Trials

The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting

LESS
Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.

NCT ID: NCT06188039 Recruiting - Surgery Clinical Trials

Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery

PRESCIENCE
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective study is to validate the superior vena cava collapsibility index (SVC-CI) as a predictor of fluid responsiveness during laparotomy and open aortic surgery. The SVC-CI and patients' response to fluid will be assessed based on transesophageal echocardiography. The study has three arms, in order to validate SVC-CI under the conditions of laparotomy, aortic cross clamping and high PEEP levels. One of the study arms will be an active comparator arm. The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner, in order to decrease perioperative mortality.

NCT ID: NCT06182254 Recruiting - Surgery Clinical Trials

Personalized Perioperative Care Based on Patient Reported Outcomes Measures

SUPPORT
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians. Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway. However data about the efficacy of PROMs-based perioperative clinical follow up are lacking. The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.

NCT ID: NCT06174324 Recruiting - Surgery Clinical Trials

Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

Start date: October 12, 2021
Phase:
Study type: Observational

The trabeculectomy is the gold standard in glaucoma surgery, nevertheless often postoperative interventions have to be done. (1),(2) The PreserFlo MicroShunt (Santen, Osaka, Japan) implantation occurs without critical steps of trabeculectomy. (3) According to a study a 20% eye pressure reduction was achieved in 53.9% of patients one year after PreserFlo MicroShunt implantation and the risk of postoperative hypotony was clearly minimized. (4) It has been shown that after trabeculectomy there is a stable development of visual fields in the first 3 months after surgery and then, despite adequate intraocular pressure reduction, visual fields deteriorate. (5) At the Klinikum Klagenfurt structural and functional changes after PreserFlo MicroShunt Implantation shall be evaluated.

NCT ID: NCT06166537 Recruiting - Surgery Clinical Trials

GRACE: Evaluating Compression Stockings in Patients That Require Extended Duration Pharmacological Thromboprophylaxis

GRACE
Start date: April 27, 2024
Phase: N/A
Study type: Interventional

Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs' ability to move oxygen from the air into the blood and may be life-threatening. This is known as pulmonary embolism (PE). DVT and PE are known collectively as venous thromboembolism or VTE. The importance of preventing VTE in surgical patients is widely recognised, with two main strategies used: thinning the blood with regular injections and/or tablets and wearing elastic stockings to help stop blood from sitting in the leg veins where it can clot. Evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of stockings over and above that of blood thinning medications. If stockings were to reduce VTE over and above blood thinning medication, these benefits need to be weighed against the risks and disadvantages of stockings, including discomfort, restricting blood flow to the leg causing blisters and wounds in addition to the cost. If stockings were found not to reduce the risk of clots, they would no longer need to be used in these patients, thus reducing the disadvantages of stockings, and saving the NHS millions of pounds per year. Certain types of operations (300,000 per year in the UK) are linked with a particularly high risk of VTE, including cancer surgery, surgery in the abdomen and pelvis, and bone (orthopaedic) surgery. In these cases, patients are offered blood thinning medications both during their hospital stay and for a period after they have left the hospital. Furthermore, these patients are offered stockings to wear while in the hospital. It is not known if, in patients who receive blood thinning medications both in hospital and after discharge, the addition of wearing stockings whilst in hospital reduces their risk of VTE any further. The purpose of this study is to investigate if it is worthwhile using stockings, in addition to blood thinning medication, to reduce blood clots after surgery. People enrolled in the study will be those at the highest risk of VTE and require an extended period of medication to reduce the risk of a blood clot. A computer will randomly choose one of the below treatments by chance to make the trial fair: A) Extended duration clot-reducing medicine in addition to stockings B) Extended duration clot-reducing medicine alone The surgery and all the other medical care will continue as normal. Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.

NCT ID: NCT06145074 Recruiting - Pancreatic Cancer Clinical Trials

Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.

IMPULS
Start date: March 20, 2024
Phase: Phase 2
Study type: Interventional

The IMPULS trial is a randomized, triple-blinded, placebo controlled, single center, pilot trial examining the efficacy and safety of preoperative propranolol in patients scheduled for pancreatic cancer surgery. The study is conducted as a type 1 hybrid efficacy-implementation trial of 30 patients. This study is designed to provide pilot data for a future larger perioperative study of propranolol with the aim of improving outcomes for pancreatic cancer surgery. In total, 30 participants will be allocated in a 1:1 ratio with 15 participants enrolled in each trial arm (propranolol vs. placebo). Participants will be allocated to either 40 mg propranolol twice daily or placebo twice daily in 10 days prior to planned surgery. Primary outcomes: Evaluating the efficacy of preoperative propranolol on anxiety and in pro-tumorigenic changes (e.g., in the tumor tissue and in blood samples) in patients undergoing surgery for pancreatic cancer. Furthermore, to obtain follow up data (e.g., 90-day mortality, postoperative complications etc. on the patients receiving propranolol versus placebo). Heart rate variability among the participants will also be examined. Secondary: Examining the safety and tolerability of 40 mg preoperative propranolol twice daily in patients undergoing surgery for pancreatic cancer. Tertiary: Evaluating the feasibility and implementation of the trial (using the APEASE framework). This will help identify barriers and enablers to a future larger study. Short-time propranolol treatment is considered safe with a mild and manageable safety-profile. Risk-management, mitigations and guidelines to ensure patient safety is included in the protocol. Since this clinical trial is exploratory in nature, no sample-size calculation is performed.

NCT ID: NCT06137781 Recruiting - Surgery Clinical Trials

Digital Prehabilitation for Patients Undergoing Major Elective Surgery

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Prehabilitation describes the process of improving someone's functional capacity before major surgery. Prehabilitation commonly focuses on exercise training, as fitness level is a predictor of surgical outcomes - the fitter you are before surgery, the lower the risk of complications after surgery. Typically, exercise training is done at the hospital, but research shows that patients would prefer to do prehabilitation exercises in their home. The goal of this study is to test the feasibility of an online prehabilitation programme made by PreActiv, which can be accessed at home via a website by patients who are awaiting major surgery. PreActiv's prehabilitation programme is six weeks long, and involves three 35-minute exercise sessions per week, with each session including a warm-up, cardio exercises, muscle strengthening exercises, and breathing exercises. Information from this pilot study on the number of exercise sessions attended (adherence) and the number of patients who complete the study (retention) will be used to decide whether we should progress to a larger study that assesses the effectiveness of PreActiv's prehabilitation.

NCT ID: NCT06120426 Recruiting - Surgery Clinical Trials

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

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

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

NCT ID: NCT06103136 Recruiting - Surgery Clinical Trials

Maestro 1.0 Post-Market Registry

Start date: September 29, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

NCT ID: NCT06101511 Recruiting - Surgery Clinical Trials

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

GENERATOR
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.