View clinical trials related to Anastomotic Leak.
Filter by:A randomised feasibility study into the use of endoscopic visualisation of rectal anastomosis vs. current practice and the effect on anastomotic leak rates in patients undergoing rectal surgery for bowel cancer in a tertiary referral centre
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process, participant experience and study management.
Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost. The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.
Introduction: Colorectal surgery (CRS) is associated with high morbidity rates, being anastomotic leakage (AL) one of the most serious complications with an incidence as high as 15%, accounting for up to a third of mortality in these procedures. The identification of pre-clinical markers may allow an early diagnosis and a timely intervention. Objective: To compare the performance of neutrophil-to-lymphocyte ratio (NLR) vs C-reactive protein (CRP) as early predictors of AL in CRS. Methodology: A retrospectively analyzed consecutive patients who underwent a colorectal surgery with anastomosis from June 2015 to April 2019. Receiver-operating characteristic (ROC) curves were used to find the cutoff points with the best diagnostic performance of AL.
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.
To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.
Cytoreductive surgery is currently the main treatment for advanced epithelial ovarian cancer (AEOC), and the complete disease removal (RT=0) or the achievement of an optimal residual disease (RT < 1 cm) remain the factors with the greatest prognostic impact, both in primary debulking surgery (PDS) and interval debulking surgery (IDS). To achieve the no residual disease (RT=0), several surgical manoeuvres are often needed both at the upper and lower abdomen, including intestinal resections. Recto-sigmoid resection is certainly the most frequent of intestinal resections, and it is also the one with the highest risk of complication. Albeit rare, anastomosis leakage (AL) is a life-threating condition and therefore it is the most feared of intestinal complications. The aim of this large single-center retrospective study was to assess the AL rate in patients subjected to colorectal resection and anastomosis during primary surgery (PDS or IDS) for advanced ovarian cancer, in a third referral centre for gynecologic oncology with ESGO certification. In addition, we evaluated several possible pre/intra and post-operative risk factors for AL in order to identify, at an early stage, the population at greatest risk, and attempt to reduce the morbidity and mortality of this severe post-operative complication
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication. The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.
Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses [1-4]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence [5, 6]. There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity [9]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication [7]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence [8-11]. With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green [12, 13] or the application of anastomotic sealants [14], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" [15-17]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails [15-17]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.
The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.