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Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

ABSTRACT: INTRODUCTION:Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy is performed. METHODS AND ANALYSIS:A single-centre, double-blind, randomised trial. After screening for eligibility and informed consent, 300 patients admitted for acute calculus cholecystitis will be randomised into two groups of treatment, either receiving amoxicillin/clavulanic acid or placebo for 5 consecutive days. Postoperative evaluation will take place during the first 30?days. Postoperative infectious complications are the primary end point. Secondary end points are length of hospital stay, readmissions, need of reintervention (percutaneous or surgical reinterventions) and overall mortality. The results of this trial will provide strong evidence to either support or abandon the use of antibiotics after surgery, impacting directly in the incidence of adverse events associated with the use of antibiotics, the emergence of bacterial resistance and treatment costs. ETHICS AND DISSEMINATION:This study and informed consent sheets have been approved by the Research Projects Evaluating Committee (CEPI) of Hospital Italiano de Buenos Aires (protocol N° 2111). RESULTS:The results of the trial will be reported in a peer-reviewed publication. TRIAL REGISTRATION NUMBER:NCT02057679.

SUBMITTER: Pellegrini P

PROVIDER: S-EPMC4654351 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

Pellegrini Pablo P Campana Juan Pablo JP Dietrich Agustín A Goransky Jeremías J Glinka Juan J Giunta Diego D Barcan Laura L Alvarez Fernando F Mazza Oscar O Sánchez Claria Rodrigo R Palavecino Martin M Arbues Guillermo G Ardiles Victoria V de Santibañes Eduardo E Pekolj Juan J de Santibañes Martin M

BMJ open 20151118 11

<h4>Introduction</h4>Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis ...[more]

PMID: 26582405

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Project description:BackgroundSevere adhesions and fibrosis between the posterior wall of the gallbladder and liver bed often render total cholecystectomy after percutaneous transhepatic gallbladder drainage (PTGBD) difficult, leading to high open conversion rates. Since the publication of Tokyo Guidelines 2018 (TG18), our policy has shifted from open conversion to subtotal cholecystectomy (SC) when total laparoscopic cholecystectomy for difficult cases of cholecystitis is not feasible. Recently, SC has been frequently applied as bailout surgery for complicated cholecystitis. Nonetheless, the efficacy and validity of laparoscopic SC after PTGBD remain unclear. This study aimed to evaluate the safety and feasibility of laparoscopic SC after PTGBD for grade II or III acute cholecystitis (AC) by comparing two periods of altered surgical strategies.MethodsThis retrospective cohort study was conducted between January 2013 and December 2020. A total of 44 eligible patients with grade II or III AC were divided according to the time of cholecystitis onset into the pre-TG18 group (2013-2017, n = 17) and post-TG18 group (2018-2020, n = 27). Patients' background demographics, surgical method, surgical results, and postoperative complications were compared.ResultsThe interval between PTGBD and surgery was significantly longer in the post-TG18 group than in the pre-TG18 group (15 [interquartile range: 9-42] days vs. 8 [4-11] days; P = 0.010). The frequency of laparoscopic cholecystectomy significantly increased from 52.9% in the pre-TG18 group to 88.9% in the post-TG18 group (P = 0.007), whereas the frequency of SC was 23.5% and 40.7%, respectively, which showed no statistically significant difference (P = 0.241). However, the rate of laparoscopic SC significantly increased from 0 to 90.9% among 15 SC cases, whereas the rate of open SC significantly plummeted from 100 to 9.1% (P = 0.001). Significant differences in the operative time, amount of intraoperative bleeding, and incidence of postoperative complications (wound infection and subhepatic abscess) were not observed. Mortality, bile leakage, and bile duct injury did not occur in either group.ConclusionsFor grade II or III AC after PTGBD, aggressive adoption of SC increased the completion rate of laparoscopic surgery. Laparoscopic SC is a safe and feasible treatment option.

Project description:BackgroundAcute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is the early laparoscopic cholecystectomy; however, the Tokyo Guidelines (TG) advocate for different initial treatments in some subgroups of patients without a strong evidence that all patients will benefit from them. There is no clear consensus in the literature about who is the unfit patient for surgical treatment. The primary aim of the study is to identify the risk factors for mortality in ACC and compare them with Tokyo Guidelines (TG) classification.MethodsRetrospective unicentric cohort study of patients emergently admitted with and ACC during 1 January 2011 to 31 December 2016. The study comprised 963 patients. Primary outcome was the mortality after the diagnosis. A propensity score method was used to avoid confounding factors comparing surgical treatment and non-surgical treatment.ResultsThe overall mortality was 3.6%. Mortality was associated with older age (68 + IQR 27 vs. 83 + IQR 5.5; P = 0.001) and higher Charlson Comorbidity Index (3.5 + 5.3 vs. 0+2; P = 0.001). A logistic regression model isolated four mortality risk factors (ACME): chronic obstructive pulmonary disease (OR 4.66 95% CI 1.7-12.8 P = 0.001), dementia (OR 4.12; 95% CI 1.34-12.7, P = 0.001), age > 80 years (OR 1.12: 95% CI 1.02-1.21, P = 0.001) and the need of preoperative vasoactive amines (OR 9.9: 95% CI 3.5-28.3, P = 0.001) which predicted the mortality in a 92% of the patients. The receiver operating characteristic curve yielded an area of 88% significantly higher that 68% (P = 0.003) from the TG classification. When comparing subgroups selected using propensity score matching with the same morbidity and severity of ACC, mortality was higher in the non-surgical treatment group. (26.2% vs. 10.5%).ConclusionsMortality was higher in ACC patients treated with non-surgical treatment. ACME identifies high-risk patients. The validation to ACME with a prospective multicenter study population could allow us to create a new alternative guideline to TG for treating ACC.Trial registrationRetrospectively registered and recorded in Clinical Trials. NCT04744441.

Project description:The laparoscopic cholecystectomy (LC) is an important approach of treating acute cholecystitis and the timing of performing this given treatment is associated with clinical outcomes. Although several meta-analyses have been done to investigate the optimal timing of implementing this treatment, the conflicting findings from these meta-analyses still confuse decision-making. And thus, we performed this systematic review to assess discordant meta-analyses and generate conclusive findings to facilitate informed decision-making in clinical context eventually. We electronically searched the PubMed, Cochrane Library, and EMBASE to include meta-analysis comparing early (within 7 days of the onset of symptoms) with delayed LC (at least 1 week after initial conservative treatment) for acute cholecystitis through August 2015. Two independent investigators completed all tasks including scanning and appraising eligibility, abstracting essential information using prespecified extraction form, assessing methodological quality using Oxford Levels of Evidence and Assessment of Multiple Systematic Reviews (AMSTAR) tool, and assessing the reporting quality using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), as well as implementing Jadad algorithm in each step for the whole process. A heterogeneity degree of ≤50% is accepted. Seven eligible meta-analyses were included eventually. Only one was Level I of evidence and remaining studies were Level II of evidence. The AMSTAR scores varied from 8 to 11 with a median of 9. The PRISMA scores varied from 19 to 26. The most heterogeneity level fell into the desired criteria. After implementing Jadad algorithm, 2 meta-analyses with more eligible RCTs were selected based on search strategies and implication of selection. The best available evidence indicated a nonsignificant difference in mortality, bile duct injury, bile leakage, overall complications, and conversion to open surgery, but a significant reduction in wound infection, hospitalization, and operation duration and improvement of the quality of life when compared early LC with delayed LC. However, number of work days lost, hospital costs, and patient satisfaction are warranted to be assessed further. With the best available evidence, we recommend early LC to be as the standard treatment option in treating acute cholecystitis.

Dataset Information

Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

Publications

Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

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