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Abdominal Injuries clinical trials

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NCT ID: NCT03920163 Recruiting - Clinical trials for Penetrating Abdominal Trauma

Enhanced Recovery After Trauma Surgery

Start date: March 29, 2019
Phase: N/A
Study type: Interventional

ERAS IN TRAUMA Enhanced recovery after surgery (ERAS) or enhanced recovery protocols (ERP) is a concept first described by Kehlet in the early 1990s .Since its introduction, ERAS protocols have been successfully used in elective gastrointestinal surgery (colorectal, hepatobiliary and gastric), and there has been widespread acceptance and implementation in other surgical disciplines including urology, vascular , thoracic surgery and orthopaedics. The approach employs a multimodal perioperative care pathway designed to attenuate the surgical stress response and accelerate postoperative recovery . These benefits should be easily transferrable to the trauma patient population, if not greater, since trauma patients are generally younger, fitter and metabolically stable. Trauma centres in developing countries constantly battle with reduced bed availability and restricted health care budgets. Optimization of health care practice is therefore urgent, particularly in trauma surgery. Penetrating abdominal trauma is a major cause of morbidity and mortality in large urban trauma centres. It accounts for a significant number of hospital admissions and consumes a large portion of the health care budget. In the trauma patient, the aim is to maintain the 'pre- injury' physiological status. Improving patient outcomes with reduced morbidity and early hospital discharge reduces the cost of treating these patients . The small pilot study by Moydien et al., showed that ERPS can be successfully implemented with significant shorter hospital stays without any increase in postoperative complications in a select group of trauma patients undergoing emergency laparotomy for isolated penetrating abdominal trauma. Furthermore, the study showed that ERPS can also be applied to patients undergoing emergency surgery. Given the fact that penetrating abdominal trauma remains a substantial burden of disease, especially in developing countries such as South Africa, this proven approach to patient care in elective surgery can now be safely employed in the trauma and emergency setting. Penetrating abdominal trauma remains a substantial burden of disease, especially in developing countries such as South Africa, and especially the Western Cape, where we have seen an increase in the number of trauma patients being treated for penetrating injuries at our level 1 centre. This has in turn led to severe constraints on the available resources, with the trauma ward often at maximum capacity with delayed discharges due to poor ambulation, post operative complications, and delay in return to enteral feeding. Currently there is no randomized controlled study in the trauma literature, evaluating enhanced recovery after trauma procedures .It is our hypothesis to that implementing an "ERATS" protocol , will lead to a reduction in morbidity, reduction in hospital stay , with a subsequent decrease in costs. This will allow us to implement this as a new standard protocol , and thus change the current practice in stable penetrating trauma patients undergoing explorative laparotomy in our unit, nationally and worldwide.

NCT ID: NCT03515811 Recruiting - Thoracic Diseases Clinical Trials

A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

Start date: January 22, 2019
Study type: Observational

The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.

NCT ID: NCT03490929 Recruiting - Trauma Abdomen Clinical Trials

CEUS for Blunt Abdominal Trauma in Children

Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

NCT ID: NCT03473249 Recruiting - Accidental Fall Clinical Trials

Effectiveness of Contrast-Enhanced Ultrasound

Start date: May 9, 2018
Phase: Phase 4
Study type: Interventional

The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.

NCT ID: NCT03147690 Recruiting - Abdominal Injury Clinical Trials

Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children

Start date: November 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.

NCT ID: NCT03109483 Recruiting - Stroke Clinical Trials

Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL). Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation; strength, balance, speed, functional training and one day is for testing or group therapy. Participants will be followed for four weeks, with testing on day one, after two weeks and at the last day of the four-week program.

NCT ID: NCT02831556 Recruiting - Pregnancy Clinical Trials

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Start date: July 2016
Study type: Observational

Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

NCT ID: NCT02829125 Recruiting - Abdominal Injuries Clinical Trials

Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery

Start date: January 1, 2015
Phase: N/A
Study type: Observational

The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs. Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.

NCT ID: NCT02542241 Recruiting - Abdominal Injuries Clinical Trials

Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Start date: December 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether hypertonic saline solution is effective in the resuscitation of traumatized patients undergone abdominal damage control surgery regarding early closure of the abdominal wall.

NCT ID: NCT01853735 Recruiting - Clinical trials for Trauma to the Abdomen

Enteral Feeding in the Post-Injury Open Abdomen

Start date: January 2013
Study type: Observational

The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury. Specific aims: Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO. Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO. Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.