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Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital.

ABSTRACT: Background:There is evidence-based consensus for laparoscopic cholecystectomy during index admission for predicted mild gallstone pancreatitis, defined by the absence of organ failure and of local or systemic complications. However, the optimal timing for surgery within that admission is controversial. Early cholecystectomy may shorten hospital length of stay (LOS) and increase patient satisfaction. Alternatively, it may increase operative difficulty and complications resulting in readmissions. Methods:This trial is a single-center randomized trial of patients with predicted mild gallstone pancreatitis comparing laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) at index admission within 24?hours of presentation versus after clinical resolution on clinical and patient-reported outcomes (PROs). The primary endpoint is 30-day LOS (hours) after initial presentation, which includes the index admission and readmissions. Secondary outcomes are conversion to open, complications, time from admission to cholecystectomy, initial hospital LOS, number of procedures within 30 days, 30-day readmissions, and PROs (change in Gastrointestinal Quality-of-Life Index). Discussion:The primary goal of this research is to obtain the least biased estimate of effect of timing of cholecystectomy for mild gallstone pancreatitis on clinical and PROs; the results of this trial will be used to inform patient care locally as well as to design future multicenter effectiveness and implementation trials. This trial will provide data regarding PROs including health-related quality of life that can be used in cost-utility and cost-effectiveness analyses. Trial registration number:NCT02806297, ClinicalTrials.gov.

SUBMITTER: Mueck KM

PROVIDER: S-EPMC5887782 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital.

Mueck Krislynn M KM Wei Shuyan S Liang Mike K MK Ko Tien C TC Tyson Jon E JE Kao Lillian S LS

Trauma surgery & acute care open 20180120 1

<h4>Background</h4>There is evidence-based consensus for laparoscopic cholecystectomy during index admission for predicted mild gallstone pancreatitis, defined by the absence of organ failure and of local or systemic complications. However, the optimal timing for surgery within that admission is controversial. Early cholecystectomy may shorten hospital length of stay (LOS) and increase patient satisfaction. Alternatively, it may increase operative difficulty and complications resulting in readmi ...[more]

PMID: 29766134

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Project description:ImportanceConsidering the lack of equipoise regarding the timing of cholecystectomy in patients with moderately severe and severe acute biliary pancreatitis (ABP), it is critical to assess this issue.ObjectiveTo assess the outcomes of early cholecystectomy (EC) in patients with moderately severe and severe ABP.Design, settings, and participantsThis cohort study retrospectively analyzed real-life data from the MANCTRA-1 (Compliance With Evidence-Based Clinical Guidelines in the Management of Acute Biliary Pancreatitis) data set, assessing 5304 consecutive patients hospitalized between January 1, 2019, and December 31, 2020, for ABP from 42 countries. A total of 3696 patients who were hospitalized for ABP and underwent cholecystectomy were included in the analysis; of these, 1202 underwent EC, defined as a cholecystectomy performed within 14 days of admission. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality and morbidity. Data analysis was performed from January to February 2023.Main outcomesMortality and morbidity after EC.ResultsOf the 3696 patients (mean [SD] age, 58.5 [17.8] years; 1907 [51.5%] female) included in the analysis, 1202 (32.5%) underwent EC and 2494 (67.5%) underwent delayed cholecystectomy (DC). Overall, EC presented an increased risk of postoperative mortality (1.4% vs 0.1%, P < .001) and morbidity (7.7% vs 3.7%, P < .001) compared with DC. On the multivariable analysis, moderately severe and severe ABP were associated with increased mortality (odds ratio [OR], 361.46; 95% CI, 2.28-57 212.31; P = .02) and morbidity (OR, 2.64; 95% CI, 1.35-5.19; P = .005). In patients with moderately severe and severe ABP (n = 108), EC was associated with an increased risk of mortality (16 [15.6%] vs 0 [0%], P < .001), morbidity (30 [30.3%] vs 57 [5.5%], P < .001), bile leakage (2 [2.4%] vs 4 [0.4%], P = .02), and infections (12 [14.6%] vs 4 [0.4%], P < .001) compared with patients with mild ABP who underwent EC. In patients with moderately severe and severe ABP (n = 108), EC was associated with higher mortality (16 [15.6%] vs 2 [1.2%], P < .001), morbidity (30 [30.3%] vs 17 [10.3%], P < .001), and infections (12 [14.6%] vs 2 [1.3%], P < .001) compared with patients with moderately severe and severe ABP who underwent DC. On the multivariable analysis, the patient's age (OR, 1.12; 95% CI, 1.02-1.36; P = .03) and American Society of Anesthesiologists score (OR, 5.91; 95% CI, 1.06-32.78; P = .04) were associated with mortality; severe complications of ABP were associated with increased mortality (OR, 50.04; 95% CI, 2.37-1058.01; P = .01) and morbidity (OR, 33.64; 95% CI, 3.19-354.73; P = .003).Conclusions and relevanceThis cohort study's findings suggest that EC should be considered carefully in patients with moderately severe and severe ABP, as it was associated with increased postoperative mortality and morbidity. However, older and more fragile patients manifesting severe complications related to ABP should most likely not be considered for EC.

Project description:Background and aimsIt is difficult for women in labor to determine when best to present for hospital admission, particularly at first childbirth. While it is often recommended that women labor at home until their contractions have become regular and ≤ 5-minutes apart, little research has investigated the utility of this recommendation. This study investigated the relationship between timing of hospital admission, in terms of whether women's labor contractions had become regular and ≤ 5-minutes apart before admission, and labor progress.MethodsThis was a cohort study of 1,656 primiparous women aged 18-35 years with singleton pregnancies who began labor spontaneously at home and delivered at 52 hospitals in Pennsylvania, USA. Women who were admitted before their contractions had become regular and ≤ 5-minutes apart (early admits) were compared to those who were admitted after (later admits). Multivariable logistic regression models were used to assess associations between timing of hospital admission and active labor status on admission (cervical dilation 6-10 cm), oxytocin augmentation, epidural analgesia and cesarean birth.ResultsNearly two-thirds of the participants (65.3%) were later admits. These women had labored for a longer time period before admission (median, interquartile range [IQR] 5 hours (3-12 hours)) than the early admits (median, (IQR) 2 hours (1-8 hours), p < 0.001); were more likely to be in active labor on admission (adjusted OR [aOR] 3.78, 95% CI 2.47-5.81); and were less likely to experience labor augmentation with oxytocin (aOR 0.44, 95% CI 0.35-0.55); epidural analgesia (aOR 0.52, 95% CI 0.38-0.72); and cesarean birth (aOR 0.66, 95% CI 0.50-0.88).ConclusionsAmong primiparous women, those who labor at home until their contractions have become regular and ≤ 5-minutes apart are more likely to be in active labor on hospital admission and less likely to experience oxytocin augmentation, epidural analgesia and cesarean birth.

Dataset Information

Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital.

Publications

Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital.

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