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72 active trials for Surgery- Complications

BiZact Tonsillectomy in the Pediatric Population

This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Start: June 2021

The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

Start: June 2021

Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction

Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction. However, most studies were conducted by single centers and had small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction using international multi-center data.

Start: May 2020

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Start: March 2020

The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

STUDY SUMMARY Incisional hernias, or swellings of the abdominal scar after surgery, remain problematic especially after transplant surgery. This is because they can cause complications, including trapping of bowel or the transplant. This can cause life threatening emergencies but is at the very least unsightly and uncomfortable for the patient. Transplant patients are especially likely to develop hernias because of the diseases causing the renal failure and the drugs that they take to dampen the immune system. There is evidence from other surgery that the stitching methods that are used to close the wounds might decrease the risk of surgical hernias. This is achieved by placing smaller and more numerous sutures (stitches) in the wound to increase the strength of the repair. However, this has never been tested formally in transplant where it may provide significant benefit. We intend to do some initial investigation of whether using the smaller stitches may provide benefit over more traditional methods that are currently being used. We will look at early complications after surgery but also the rate of hernia formation later. We hope to improve outcomes and reduce complications for our transplant patients by doing this. In addition we will collect blood and tissue samples from both live kidney donors and the recipients to microscopically analyse their collagen to identify potential factors which may indicate risk of hernia formation.

Start: March 2020

Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

Start: July 2021

Respiratory Strength Training in Cardiac Surgical Patients

Swallowing difficulty (dysphagia) is a common postoperative complication in patients who undergo cardiac surgical procedures. Postoperative dysphagia in cardiac surgical patients is associated with negative health-related outcomes including increased rates of pneumonia, reintubation, and death as well as increased length of hospital stay and costs of care. This study will examine the safety, feasibility, and impact of preoperative respiratory strength training (RST) on swallowing and associated health-related outcomes in cardiac surgical patients. We hypothesize that preoperative RST will be safe, well-tolerated, and lead to improved swallowing and health-related outcomes in cardiac surgical patients.

Start: June 2021

Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation

The overarching objective of the research program entitled ELIPTO (Enhancing Liver Insufficiency and Postoperative Transplantation Outcomes) (www.elipto.ca) is to improve the perioperative care of liver transplant recipients. One of this program's purposes is to better define the effects of intraoperative hemodynamic management on postoperative outcomes in adult liver transplant recipients. In this study, the incidence of postoperative complications within this population will be defined in Canada and the association between intraoperative hemodynamics and postoperative outcomes will be measured. Liver transplantation improves the survival of patients with end-stage liver disease (ESLD). It is the second most transplanted organ with a continuously increasing annual number of transplantations, an observation partly explained by an endemic ESLD etiology in the United States, the obesity-related non-alcoholic steatohepatitis (NASH) cirrhosis. In recent decades, although sicker patients are prioritized, survival has improved possibly through an overall improvement in the quality of care. However, postoperative complications have concomitantly increased. On average, liver transplant recipients suffer from more than three postoperative complications, mainly infectious, pulmonary, renal or graft-related, two thirds of them being severe. In a low-risk patients cohort, close to 60% of all patients suffered from at least one severe complication up to 6 months after surgery. Such complications increase mortality, readmissions and cost of care. Organs available for transplantation are a scarce resource; up to 10% of grafts are no longer functional after one year. Interventions that improve patients' postoperative and graft outcomes are needed and few perioperative ones are supported by high-quality evidence.

Start: June 2021

Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery

This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit (CVICU), and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.

Start: May 2021

Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery

Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning.

Start: January 2012

Pilot Study for Postoperative Machine Learning

The objectives of the study are to determine the interpretability, workflow role, and effect on communications of showing report cards containing Machine Learning (ML)-based risk profiles based on pre- and intra-operative data to postoperative providers.

Start: May 2021

Zinc Oxide Versus Petrolatum Following Skin Surgery

Patients undergoing routine surgery in the Department of Dermatology for any indication on non-scalp skin and closed in linear fashion with scar greater than or equal to 4.5cm in length will be invited to participate in this split scar, head to head study comparing zinc oxide and petrolatum. Patients will apply respective ointments to each half of scar daily for one month and maintain a log of these activities. They will be seen at 1 week, 4 weeks, 8 weeks, and 6 months post-operatively for photographic scar assessment and to complete the patient portion of the Patient and Observer Scar Assessment Scale (POSAS), a quantitative objective assessment of scar appearance. Trained observers (board-certified dermatologists) will score the observer portion of the scale. POSAS outcomes, post-operative infections, linear density of epidermal seal will be assessed at the 1 week, 4 weeks, 8 weeks, and 6 months post-operative periods and compared between the two groups. Participants will have parking validated for all visits and upon completion of all portions of the study will receive a standardized skin care gift bag containing samples for hypoallergenic skin care products (washes, moisturizers, etc.).

Start: June 2021

Wound And Symptom Tracking After Colorectal Surgery Using How2trak

The purpose of this study is to assess the feasibility of using a mobile application (app) called how2trak to improve people's experience, wound surveillance, and detection of surgical site infections (SSI) after colorectal surgery while reducing in-person interactions for patients during the COVID-19 pandemic. This will inform the implementation of a full-scale trial to establish if surveillance of someone's incision and symptoms using how2trak improves SSI detection and management compared to standard care (involving a single post-operative surgery clinic visit). The data collected will contribute to a broader dataset of people with SSI surveillance to be used in developing a clinical decision support system.

Start: May 2021

Ureteral Jets and Patient Positioning Study

The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.

Start: February 2021

Intraoperative Phlebotomies and Bleeding in Liver Transplantation

Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery. To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.

Start: March 2021

Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

Start: September 2021

Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety

Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.

Start: July 2019

Management of Antiplatelet Regimen During Surgical Procedures

There are key differences today in clinical practice regarding perioperative management of post-PCI patients on DAPT undergoing NCS. Moreover, there are significant differences between bridging agents, and improved safety of current-generation DES. Given the significant limitations of current studies a well-designed registry to study current U.S. practice patterns and the bleeding or ischemic risks associated with the various perioperative DAPT management strategies including bridging and no bridging will significantly add to the understanding of the current problem and associated risks of patients. These data could form the basis for conducting future randomized clinical trials (RCTs) in this area. NCS in post-PCI patients on chronic DAPT presents a complex interaction of both ischemic and bleeding risks. The MARS registry will study the area of perioperative antiplatelet therapy management through a multicenter observational national registry designed to collect pre-operative, intra-operative and post-operative clinical strategies, therapeutic interventions and outcomes data. This proposal outlines the role of a highly experienced clinical trial team to conduct a multicenter prospective registry. This question is highly relevant to a diverse group of medical providers and millions of patients in the US and around the world; this will be the first such U.S. registry to address this critically important public health issue. Study objectives: i. To collect data on contemporary clinical practice in the U.S. on managing post percutaneous coronary intervention (PCI) DAPT in patients scheduled to undergo NCS and CS. ii. To assess ischemic and bleeding endpoints in this group of patients during the study period. iii. To generate initial data to plan for future large-scale randomized clinical trials on perioperative management of DAPT.

Start: August 2019

Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)

There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery. The investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery. The investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay). The investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity. The investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study. Immediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery. If the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery. This might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)

Start: September 2022

Goal-directed Therapy in Neurosurgery.

The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.

Start: March 2021