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Surgery clinical trials

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NCT ID: NCT03926715 Recruiting - Cancer Clinical Trials

Prevalence of Malnutrition in Surgery

PROMIS
Start date: January 6, 2017
Phase:
Study type: Observational

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

NCT ID: NCT03919370 Recruiting - Surgery Clinical Trials

Detection of Cerebral Ischemia With Artificial Intelligence.

CIDAI-BAS
Start date: October 1, 2020
Phase:
Study type: Observational

In patients undergoing planned surgery for carotid tromendarterendectomy, a non-invasive device that registers heart rate variability is attached. Furthermore a non-invasive device that monitors cerebral oxygenation- near infrared spectroscopy as well as electroencephalography is also attached. At times when surgeons clamps the carotid artery, there will be a moment with controlled cerebral ischemia. This will be registered by the devices. The information obtained will be used to teach artificial intelligence what patterns are related to cerebral ischemia. The same procedure will be performed in patients undergoing ocklusive cerebral trombectomy, so the artificial intelligence will learn to recognize cerebral reperfusion.Blood samples will be drawn before and after cerebral ischemia may occur and will be analyzed for neurobiomarkers and cardiac biomarkers. To teach the algorithm patterns from anaesthesia and surgery in patients without pre existing neuronal injury, the same method will be applied to patients undergoing mixed abdominal surgery. This group will provide a better knowledge of neuro biomarker patterns during anesthesia and surgery.

NCT ID: NCT03913299 Recruiting - Surgery Clinical Trials

Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery

FRAIL-HEART
Start date: April 23, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

NCT ID: NCT03905005 Recruiting - Surgery Clinical Trials

Jaw Reconstruction With Printed Titanium and Free Tissue Transfer

JaW PrinT
Start date: March 12, 2018
Phase:
Study type: Observational

JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.

NCT ID: NCT03861026 Recruiting - Surgery Clinical Trials

Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery

Start date: October 5, 2018
Phase: N/A
Study type: Interventional

Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery. The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients. The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM). A secondary aim is to determine a cost-effectiveness of this monitoring modality.

NCT ID: NCT03844347 Recruiting - Surgery Clinical Trials

Well-being and Stress Control After Colorectal Surgery

C-Bien
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

The criteria usually considered to evaluate the quality of life are the presence or absence of a stomy, alteration of the transit or the sexual dysfunctions. Quality of life has been improved by introducing an Enhanced Postoperative Rehabilitation Program After Surgery (ERAS). It is a multidisciplinary medical and paramedical care aimed at minimizing the sources of stress allowing a significant reduction in postoperative complications and length of stay. However, the emotional feelings of patients, their fatigue, the quality of their relationships with others and their experience of the disease are not usually considered. Nevertheless, these criteria influence the quality of life and constitute the fundamental bases of the psychological well-being, essential in the recovery processes. We propose to enrich the ERAS program by introducing an individualized support of well-being and stress management aimed at increasing the quality of life of patients. The purpose is to make the patient more autonomous by allowing him/her, to implement stress management exercises. The main goal of the project is to improve the psychological well-being of patients operated on for colorectal cancer by offering stress management sessions in order to promote postoperative rehabilitation. The secondary objectives are to demonstrate the impact of stress management sessions on the length of stay and to study the link between the efficiency of these sessions and the quality of life of patients before the surgery.

NCT ID: NCT03843645 Recruiting - Surgery Clinical Trials

General Versus Regional Anesthesia and Postoperative Sleep Quality

AnesthSleep
Start date: February 10, 2019
Phase: N/A
Study type: Interventional

Major surgery can lead to postoperative disturbances in sleep patterns with subjective deterioration of sleep quality according to patients' reports as well as objective alterations of sleep architecture, as recorded by polysomnography Factors implicated in postoperative sleep disturbances include but are not limited to the severity of the surgical procedure, the neuroendocrine response to surgery, inadequate treatment of postoperative pain and external factors interfering with sleep, such as light, noise and therapeutic procedures There are no adequate data from current literature as to whether regional anesthesia is superior to general anesthesia regarding postoperative sleep quality in patients subjected to either mode of anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques (general versus regional) in patients subjected to similar operations Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI), regarding preoperative and long term postoperative sleep quality and sleep diaries regarding early postoperative sleep quality

NCT ID: NCT03838575 Recruiting - Surgery Clinical Trials

ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

ROSSINI 2
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

ROSSINI 2 is a phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.

NCT ID: NCT03828318 Recruiting - Surgery Clinical Trials

Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed. The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer. This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.

NCT ID: NCT03825198 Recruiting - Surgery Clinical Trials

Lumbar Erector Spinae Plane Block for Back Surgery

LUMBES
Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

Title: A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion surgery. Objectives: The primary objective is to study the influence of a bilateral erector spinae block on 24h morphine consumption. Endpoint: The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are intraoperative sufentanil requirement, total morphine during first 72 postoperative hours, NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively Population: Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3 Number of sites Enrolling participants: University Hospital Antwerp &AZ KLINA Brasschaat Description of study agent: Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml epinephrine Study duration Until the required study population is met Participant duration 72 hours