View clinical trials related to Anastomotic Leak.
Filter by: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.
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.
The PROFUGO study (PRedictive Model for the early diagnosis of anastomotic leak after esophagectomy and gastrectomy) is proposed as a prospective and multicenter study at spanish national level that aims to develop, with the help of artificial intelligence methods, a tool and predictive model that allows identifying cases with a high risk of anastomotic leak (AF) and/or major complications through the analysis of different clinical and analytical variables collected during the perioperative period of patients undergoing esophagectomy or gastrectomy. 2.-HYPOTHESIS Early identification of patients at high risk of developing AF and/or major complications after esophagogastric surgery can be carried out through the perioperative study of objective clinical variables and analytical markers. 3.-OBJECTIVE The main objective of the study is to design a predictive model based on clinical and analytical variables that allow the identification of patients with a high risk of anastomotic leak (main variable) and/or major complication during the postoperative period of esophagogastric surgery. 4.-MATERIAL AND METHODS - DESIGN: Prospective and multicenter study of 1 year duration. - STUDY POPULATION: Patients diagnosed with neoplasia of the esophagus or stomach with an indication for oncological surgery with curative intent. - INCLUSION CRITERIA: patients with surgical indication and curative intention due to esophagogastric neoplasm who do not meet exclusion criteria and recruited by hospitals nationwide that decide to participate in the study. - EXCLUSION CRITERIA - Patients under 18 or over 85 years - Patients with chronic infections - Patients with synchronous tumors in other locations - Patients with autoimmune disease - Patients who die in the operating room - Patients who do not sign the informed consent to participate in the study - Patients in clinical stage IVB - Surgical resection R2 (there are macroscopic remains of the tumor in the surgical field after performing the resection of the surgical piece) - Combined intraoperative resection of other organs - Surgeries without anastomosis - MONITORING: The patient will be monitored during the first 90 postoperative days. 5.-DURATION OF THE STUDY The time for the inclusion of patients in the study will be 1 year in each center from the incorporation of the first of their patients.
Higher anastomotic leakage (AL) rate is reported after ileosigmoid (ISA) or ileorectal anastomosis (IRA) in total or subtotal colectomy (TSC) compared to colonic or colorectal anastomosis. An AL reduction in these cases may improve short and long terms outcomes significantly. Current evidence remains insufficient to assess AL risk after TSC, based on single-center studies or small cases series. The investigators aim to analyse and identify potential risk factors to AL following TSC and ISA or IRA, both preoperative and intraoperative in order to prevent surgical complications. The study is set up as a retrospective multicentre observational study. Inclusion criteria are patients (1) over 18 years old, (2) underwent restorative TSC with ISA or IRA anastomosis, (3) with/without loop ileostomy (4) between 2013-2019. Exclusion criteria are: (1) non-restorative TSC, (2) previous colorectal resection, (3) deferred anastomosis in trauma surgery and (4) other surgical resection in the same procedure. AL will be defined as a defect of the integrity of the intestinal wall at the anastomotic site leading to a communication of the intra and extraluminal or a pelvic abscess adjacent to the anastomosis according to the definition set by de International Study Group of Rectal Cancer. AL requiring no active therapeutic intervention will be classified as Grade A. AL requiring active therapeutic intervention (antibiotics and percutaneous drainage) but manageable without relaparotomy will be classified as Grade B and AL requiring re-intervention were classified as Grade C. Multivariable logistic regression model will be used in order to assess potential AL risk factors. p value <0,05 will be consider to indicate statistical significance. Primary outcome is to assess potential risk factors to AL after restorative (ISA or IRA) TSC. Secondary outcomes are to identify risk factors to associated postoperative morbidity, mortality and re-admissions. Data will be collected in each participating center enrolled in the study by the assigned principal investigator, confidentially and codified. Data will be sent to the study principal investigator. Database, patients code and email address will be provided at the study inclusion.
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures. The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood. The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures. After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture. This is prospective study. Anticipated cohort of 50 patients