View clinical trials related to Anastomotic Leak.
Filter by:Anastomotic leakage is a severe complication that can arise following a colorectal resection. It impairs both the short- and long-term outcomes, and negatively influences cancer recurrence rates. Its detrimental effects resound in healthcare costs of a patient after anastomotic leakage, €71,978, versus patients with an uncomplicated course, €17,647. Despite multiple innovations within the field of colorectal surgery, the incidence of colorectal anastomotic leakage did not reduce in the past decade. Mitigation strategies such as prehabilitation, intraoperative optimization, selective bowel decontamination, and reconstruction techniques are promising but do not completely eliminate the risk of leakage. The only true prevention of colorectal anastomotic leakage is the omission of an anastomosis and implies an ostomy, which in itself has a negative impact on the quality of life. A stoma is associated with stoma-related morbidity and should, therefore, be avoided in patients who do not need it. Predicting anastomotic leakage intra-operatively, just before the construction of the anastomosis, may offer a solution. A stoma will then only be constructed in those at high risk of anastomotic leakage. Currently, there are prediction models for anastomotic leakage based on conventional multivariate logistic regression analysis, however, these are not useful for clinical practice due to suboptimal results. Machine learning algorithms, on the other hand, take well into account the multifactorial nature of complications and might thus be able to predict anastomotic leakage more accurately. The machine learning model we created proved to be well capable of making accurate predictions. This model was developed based on a database containing both pre- and intra-operative data from 2,483 patients. Before these models can be used in daily practice, external validation is essential. Our models should be tested on unseen data from patients treated in centers that were not previously involved in the database that was used to train the model in order to achieve high reproducibility. Our hypothesis is that with our model, we can accurately predict anastomotic leakage intra-operatively during colorectal surgery.
The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable. A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source. An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions. The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.
The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is: • If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity. Participants admitted for stoma reversal will be divided into two groups: 1. EE: Conventional Hand-sewn end-to-end anastomosis, and 2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups: 1. HSSA: Hand-sewn side-to-side anastomosis 2. SSSA: Stapled side-to-side anastomosis Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see: 1. Rates of major post-operative complications 2. Rates of short-term complications (within 30 days of surgery) 3. Rates of re-operation 4. Post-operative length of stay in the hospital
This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.
Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.
Anastomotic complications are serious complications after anus preserving surgery for rectal cancer,the instrument anastomosis technology are one of the factors that influence the occurrence of anastomotic complications after surgery,the laparoscopic linear cutting closure device used in robotic rectal cancer may increase the occurrence of anastomotic complications,but the robot linear cutting stapler (SureForm) may reduce the incidence of postoperative anastomotic complications due to the technical advantages,therefore,the aim of this study is to evaluate the impact of robotic linear cutting stapler SureForm and laparoscopic linear cutting stapler on the incidence of anastomotic complications after robotic rectal cancer anus preserving surgery.
This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.
Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment. In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study). The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study. As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date. The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence). Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.
A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis. The registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations. During surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery. Studies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience. Assessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined. Aim: Primary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage. Secondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.
Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.