Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations - protocol for a systematic review and case-control analysis.

Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior 'IDEAL 2b-like' cohort studies and the quality and impact of surgical RCTs. We propose a systematic review using two parallel case-control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or <5) and (2) study quality (PEDro score ≥or < 7). The case/control OR of exposure to a prior '2b like' study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis. This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.

Aortic and splanchnic artery aneurysms: Unusual causes of biliary obstruction - A retrospective cohort from literature.

Mechanical obstruction of the biliary tree and resultant stasis are the cornerstone of a spectrum of diseases ranging from biliary colic to fulminant cholangitis. Infrequently acquired abnormalities of the abdominal vasculature can lead to biliary obstruction. In 2010, we reported a case of acute cholangitis resulting from compression of extra hepatic bile duct by an abdominal aortic aneurysm (AAA). We subsequently conducted a follow up scoping review of literature to identify other cases of acquired abdominal arterial abnormalities resulting in biliary obstruction looking at their management and outcomes. The articles were independently reviewed by two of the authors and pertinent data was extracted. The data was divided on an anatomic basis into two groups: one with primary aortic pathology and one with splanchnic vessel pathology. We identified 39 cases of biliary obstruction secondary to acquired aortic or splanchnic vessel abnormalities; 16 were caused by AAAs and 23 by splanchnic vessels. The cases were managed via conservative, endoscopic, endovascular or open surgical options based on the available technology and expertise. Although uncommon, recognition of aortic and splanchnic arterial abnormalities as a potential cause of biliary obstruction is important as management entails not only cautious decompression of the biliary tree but also addressing the underlying vascular pathology. We recommend that extrinsic biliary compression by an aneurysm or pseudoaneurysm be considered among the differential diagnosis in patients presenting with biliary obstruction and a known lesion of the abdominal vasculature.

The Complex Surgical Abdomen: What the Nonsurgeon Intensivist Needs to Know.

Intensivists are often called upon to help care for patients who develop severe sepsis syndrome and septic shock where the primary source is an enterocutaneous fistula (ECF). The purpose of this article is to describe to the nonsurgeon intensivist how these complex surgical situations arise in the first place and provide the reader with a detailed understanding of the potentially devastating complications of ECF. In addition, we will describe a structured algorithm regarding the management of this often highly challenging surgical situation.

Demonstration of a perihepatic abscess communicating with a fistula from the small bowel on hepatobiliary imaging.

Abscess formation after abdominal surgery is not an uncommon complication. It is much less common for a collection to be the result of a fistulous tract from the bowel. We describe a patient who underwent a Tc-99m hepatobiliary (Choletec) scan for the workup of a perihepatic abscess, which confirmed the presence of a fistulous tract from the small bowel to a perihepatic collection.

Cystic teratoma of the pancreas: presentation, evaluation and management.

CONTEXT: Congenital cystic lesions of the pancreas are rare findings. Furthermore, a dermoid cyst of the pancreas is exceptionally uncommon. A review of the world literature shows 18 documented cases. The pre-operative evaluation of this lesion is rather questionable, with definitive diagnosis taking place intra-operatively. CASE REPORT: A 52-year-old male with a symptomatic, 3-cm cystic-type mass in the pancreas. CONCLUSIONS: From our case presentation and review of the world literature, we hope to establish an increased awareness in the diagnostic evaluation of these patients.

Association of super-super-obesity and male gender with elevated mortality in patients undergoing the duodenal switch procedure.

BACKGROUND: Previous studies have reported that risk factors for elevated mortality after Roux-en-Y gastric bypass include male gender, as well as a very elevated BMI. The present study was aimed at determining whether these same risk factors applied to patients undergoing the duodenal switch (DS) operation. MATERIALS AND METHODS: A retrospective chart review was performed of a cohort of 385 patients who underwent DS. The 30-day mortality of super-superobese (SSO) patients [BMI > or =60 kg/m2 (n=102)] was compared with the mortality of the super- and morbidly obese (SMO) patients [35 or =60 kg/m2.

Urinary trypsinogen activation peptide is more accurate than hematocrit in determining severity in patients with acute pancreatitis: a prospective study.

OBJECTIVE: The management of patients with acute pancreatitis is complicated by the inability to distinguish mild from severe disease during the early stages. It has been previously shown that urinary trypsinogen activation peptide (TAP) and hematocrit (Hct) may serve as early predictors of severity in patients with acute pancreatitis. To establish which marker is more accurate in the determination of severity in patients with acute pancreatitis, a prospective study was performed. METHODS: A consecutive series of patients admitted with pain consistent with acute pancreatitis and an amylase of three times the upper limit of normal were included. The admission and 24-h Hct was obtained. A urine sample was obtained within 12 h of admission. Urinary TAP was determined using a modified solid phase ELISA. Severity was defined by the Atlanta Symposium, as the presence of organ failure and/or pancreatic necrosis. RESULTS: Fifty-eight consecutive patients with acute pancreatitis participated. There were 33 men and 25 women with a mean age of 60 +/- 19. Thirty-nine patients had mild disease; 19 had severe disease. Urinary TAP was elevated in 26 patients. All patients with severe pancreatitis were correctly identified as having severe disease by an elevated urinary TAP (sensitivity 100%, specificity 77%). The admission Hct was higher than 47 in only three patients, all with mild disease. Of the patients with a rise in Hct, eight had mild disease, and only one had severe disease. Using a Hct of 44 as a cutoff did not affect the accuracy. There was no association between a rise in Hct and failure of Hct to decrease in the determination of severity. CONCLUSIONS: In comparison to admission Hct, urinary TAP was more accurate in determining severity in patients with acute pancreatitis by Atlanta, APACHE II, and Ranson criteria. We conclude that urinary TAP is a more accurate predictor of severity in patients with acute pancreatitis compared with Hct. Urinary TAP should be used to determine severity in patients early in the course of acute pancreatitis.