Active clinical trials for "Acalculous Cholecystitis"

Acute cholecystitis is a common disease in the daily practice of general surgery. There are various methods in the treatment of this disease, such as early cholecystectomy, medical treatment, six weeks later cholecystectomy and cholecystostomy. However, it is not satisfied with objective criteria that these methods are selected according to which patient groups. With this observational-prospective study, the benefit of first visit scoring on 'which of the treatment options will be most suitable for the patient' will be investigated. Thus, rare but severe complications of cholecystectomy can be prevented.

The SPRIMACC study is a prospective multicenter observational study with the primary endpoint to prospectively validate the Chole-Risk score in predicting a complicated postoperative course (post-operative major complications (Clavien-Dindo>=3a), length of stay (LOS) > 10 days or need of readmission within 30 days from the discharge) in patients undergoing Early Cholecystectomy (EC) for Acute Calculous Cholecystitis (ACC). The secondary endpoints of the study are to prospectively validate and compare other wellknown risk prediction models (the POSSUM/P-POSSUM score, the Modified Frailty Index (mFI), the Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists (ASA) score and the APACHE II score) in predicting a complicated post-operative course in patients undergoing EC.

Percutaneous cholecystostomy (PC) is an increasingly performed procedure for acute cholecystitis (AC), safe and less invasive than laparoscopic cholecystectomy, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..) The investigators conduct a retrospective observational study. Period: 2016-2021. Inclusion criteria: Patients treated with PC for AC. Tokyo guidelines TG13/18 the investigators algorithm to treat AC. The characteristics of the sample undergoing Percutaneous Cholecystostomy, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic Acute Cholecystitis, elective vs emergency surgery or management with PC alone.

The smoke produced by the electric section of the tissues during laparoscopy alters the vision of the operative field and presents potential risks. A new medical device with CE marking (Ultravision ©) has been developed to limit electroprecipitation on the wall and tissues of the abdomen. The aim of the work is to evaluate the effectiveness of this medical device in laparoscopic cholecystectomy for cholecystitis. It is an intervention for a common pathology where smoke is particularly important due to the tissue inflammation and due to the extensive dissection necessary to perform the surgical procedure. A randomized double-blinded study will be conducted in two academic hospitals (Marseille North Hospital and Timone, APHM) evaluating the use of a smoke electroprecipitation device (Ultravision ©) during laparoscopic cholecystectomy for cholecystitis operated at the acute phase. A group of 30 patients using the device will be compared to a control group of 30 patients. The evaluation will last thirty days per patient and the duration of inclusion is 2 years. The main objective is to demonstrate a significant reduction in operating duration by using the device. The secondary objectives are to reduce the CO2 consumption, the surgical incidents and the discomfort of the surgeon related to the smoke.

Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in the small intestine. Ezetimibe has been approved for use in humans to lower serum cholesterol. The primary aim of this study is to determine if ezetimibe normalizes resting and residual volume in patients with chronic acalculous cholecystitis.

The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.

Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. The main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. The purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 8-20%, and the mortality rate is 0.5-6% in recent series. The Tokyo Guidelines (TG) advocate for different risk factors and initial treatments of ACC with no clear evidence that all patients will benefit from them. The objective of the study is to identify the risk factors for complications in ACC. It is a retrospective cohort study conducted from January 2011 to December 2016 in a single center with a dedicated surgical emergency unit in a Metropolitan University Hospital in Barcelona, Spain. The analysis of the data was finished in March 2020. The study candidates comprised 963 consecutive patients with a diagnosis of ACC according to the TG18 and/or received a diagnosis of ACC in the Pathology report in those that an emergent cholecystectomy was performed. The study case definition was a 'Pure Acute Cholecystitis' (pure ACC); therefore, patients with any other concomitant diagnosis potentially influencing outcome (Postoperative cholecystitis, Acute Cholangitis, Acute Pancreatitis, Incidental Cholecystectomy, Acalculous Cholecystitis, Chronic Cholecystitis/Persistent Colic, Post-endoscopic retrograde pancreato-cholangiography, or Neoplasia) were excluded from the final analysis. Variables: Primary data were available from a prospective database maintained in File Maker v.12 (Mountainview, CA, USA), which included basic demographic data, type of interventions, sex, days of admission, and complications. Every record was completed by browsing the electronic patient record, adding laboratory and microbiology data, as well as antibiotic therapy, duration of procedure, additional procedures, and grade of acute cholecystitis according to the TG18 diagnostic criteria. Preoperative comorbidities were assessed using the Charlson Comorbidity Index and surgical risk by ASA classification. The type of initial treatment was classified as Surgical Treatment (Cholecystectomy either by laparoscopy or laparotomy) or Non-Surgical Treatment, which was either percutaneous cholecystostomy or intravenous antibiotics alone. The main outcome measure was the mortality after the diagnostic of ACC. In the patients that were discharged, 30 days after the diagnosis, if the patients was not discharged in 30 days, at any time during the same admission. Interventions: All patients received intravenous antibiotic therapy from the moment the diagnosis was formulated, according to a fixed protocol. Ultrasound-guided cholecystostomy was performed percutaneously with an 8-Fr catheter (SKATER ™, Argon Medical Devices, Rochester, NY, USA) by either transhepatic or transperitoneal insertion, at the discretion of the radiologist. Laparoscopic Cholecystectomy was performed according to the French technique using 4 trochars. The content of the gallbladder was evacuated by Veress needle puncture when necessary. Statistical Analysis: The discrimination power of the model was assessed by receiver operating characteristic (ROC) curves and was compared with the DeLong method. Legal and Ethical considerations This study was approved by the clinical research ethical committee of the Hospital del Mar and was classified as a non-clinical trial.

Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice. Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.

Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port).