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Background: The IPAA has been successful in restoring intestinal continuity and preserving continence in the majority of patients requiring a proctocolectomy. However, a subset of individuals experience significant complications that might result in pouch failure. The conversion of the J-pouch to a continent ileostomy pouch represents a significant surgical procedure. In this article, we discuss the indications and contraindications, present the technical principles applied for the conversion, and describe the outcomes of such conversion in the literature., Objective: The main objective during the conversion of the J-pouch to a continent ileostomy is the creation of a sufficiently sized reservoir with a high-quality valve mechanism while preserving as much small bowel as possible., Conclusions: The conversion of the J-pouch to a continent ileostomy represents a significant surgical procedure. When performed in centers of expertise, it can be a good option for patients who otherwise will require an end ileostomy. Indications for conversion include most cases of J-pouch failure, with a few important exceptions. See video from symposium ., (Copyright © The ASCRS 2024.)

Background: RCTs are essential in guiding clinical decision-making but are difficult to perform, especially in surgery. This review assessed the trend in volume and methodological quality of published surgical RCTs over two decades., Methods: PubMed was searched systematically for surgical RCTs published in 1999, 2009, and 2019. The primary outcomes were volume of trials and RCTs with a low risk of bias. Secondary outcomes were clinical, geographical, and funding characteristics., Results: Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The most common subspecialty in 2019 was gastrointestinal surgery (50.7 per cent). The volume of surgical RCTs increased mostly in Asia (61, 159, and 199 trials), especially in China (7, 40, and 81). In 2019, countries with the highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect., Conclusion: The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Crohn's disease (CD) can involve the entire gastrointestinal tract from the mouth to the anus and can lead to a constellation of symptoms. With the advancement of effective medical treatments for CD, a tendency has emerged to consider surgical treatment as a last resort. This potentially has the disadvantage of delaying surgery and if it fails might leave patients sicker, less well nourished, and with more severe complications. As with most non-malignant diseases, the choice of surgery vs medical treatment is a patient's personal preference under the guidance of the treating physician, except in extreme situations where surgery might be the only option. In this article, we will discuss the available evidence regarding the optimal timing of surgery in CD, focusing on whether early surgery can bring benefits in terms of disease control, symptom relief, and quality of life., (© The Author(s) 2022. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University.)

Objectives: We developed an epidemiological algorithm to classify types of diabetes mellitus (DM) in chronic pancreatitis (CP), and applied it to a nationwide prospective longitudinal cohort of CP patients., Methods: Patients with definite CP (M-ANNHEIM criteria) were classified as having DM types 1, 2, or 3c, or no DM using an algorithm based on epidemiological characteristics: DM onset in relation to age, CP onset, exocrine insufficiency. Variables associated with development of DM were identified., Results: Of 1130 included patients with CP between 2011 and 2018, 368 patients (33%) had DM at inclusion. Among patients with DM, 11 were classified as having type 1 (3%), 159 as type 2 (43%), and 191 as type 3c (52%). Patients with DM type 3c had longer duration of CP, more severe pain and lower physical quality of life. During longitudinal follow-up of median 47 months, 120 (20%) patients developed DM, of which 99 patients were classified as type 3c. This was independently associated with pancreatic endoscopy and surgery., Conclusions: The described algorithm based on epidemiological characteristics can help to classify types of DM in patients with CP. Diabetes mellitus type 3c is associated with longer duration of CP and more severe CP sequelae., Competing Interests: M.A.B. reports receipt of institutional grants from Acelity, Johnson & Johnson, New Compliance, Bard, Gore, and Smith & Nephew outside the submitted work. M.J.B. reports receipt of grants from Boston Scientific, Cook Medical, Pentax Medical, 3M and Mylan outside the submitted work. The other authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Pain in chronic pancreatitis is subdivided in a continuous or intermittent pattern, each thought to represent a different entity, requiring specific treatment. Because evidence is missing, we studied pain patterns in a prospective longitudinal nationwide study., Design: 1131 patients with chronic pancreatitis (fulfilling M-ANNHEIM criteria) were included between 2011 and 2018 in 30 Dutch hospitals. Patients with continuous or intermittent pain were compared for demographics, pain characteristics, quality of life (Short-Form 36), imaging findings, disease duration and treatment. Alternation of pain pattern and associated variables were longitudinally assessed using a multivariable multinomial logistic regression model., Results: At inclusion, 589 patients (52%) had continuous pain, 231 patients (20%) had intermittent pain and 311 patients (28%) had no pain. Patients with continuous pain had more severe pain, used more opioids and neuropathic pain medication, and had a lower quality of life. There were no differences between pain patterns for morphological findings on imaging, disease duration and treatment. During a median follow-up of 47 months, 552 of 905 patients (61%) alternated at least once between pain patterns. All alternations were associated with the Visual Analogue Scale pain intensity score and surgery was only associated with the change from pain to no pain., Conclusion: Continuous and intermittent pain patterns in chronic pancreatitis do not seem to be the result of distinctly different pathophysiological entities. The subjectively reported character of pain is not related to imaging findings or disease duration. Pain patterns often change over time and are merely a feature of how severity of pain is experienced., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Pancreatic exocrine insufficiency (PEI) is a common complication of chronic pancreatitis. However, little is known about the natural course of PEI and the effect of pancreatic enzyme replacement therapy on symptoms. The aim of this study was to evaluate the natural course and treatment of PEI in a nationwide cohort of patients with chronic pancreatitis., Methods: Patients with chronic pancreatitis were selected from the multicenter Dutch Chronic Pancreatitis Registry. Patients were classified in 3 groups: definite PEI, potential PEI, and no PEI. Definite PEI and no PEI were compared regarding the course of disease, symptoms, treatment, and quality of life., Results: Nine hundred eighty-seven patients were included from 29 centers, of which 304 patients (31%) had definite PEI; 451 (46%), potentially PEI; and 232 (24%), no PEI. Patients with definite PEI had significantly more malabsorption symptoms, a lower body mass index, and aberrant defecation. Lowered quality of life was not independently associated with PEI. Of the PEI patients using pancreatic enzyme replacement therapy, 47% still reported steatorrhea., Conclusions: Pancreatic exocrine insufficiency is associated with malabsorption symptoms and a lower body mass index. Some form of pancreatic enzyme replacement therapy is reasonably effective in alleviating malabsorption symptoms, but improvement of treatment is needed.

Importance: For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function., Objective: To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes., Design, Setting, and Participants: The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018., Interventions: There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed., Main Outcomes and Measures: The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality., Results: Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach., Conclusions and Relevance: Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings., Trial Registration: ISRCTN Identifier: ISRCTN45877994.

Objective: In patients with pancreatitis, early persisting organ failure is believed to be the most important cause of mortality. This study investigates the relation between the timing (onset and duration) of organ failure and mortality and its association with infected pancreatic necrosis in patients with necrotising pancreatitis., Design: We performed a post hoc analysis of a prospective database of 639 patients with necrotising pancreatitis from 21 hospitals. We evaluated the onset, duration and type of organ failure (ie, respiratory, cardiovascular and renal failure) and its association with mortality and infected pancreatic necrosis., Results: In total, 240 of 639 (38%) patients with necrotising pancreatitis developed organ failure. Persistent organ failure (ie, any type or combination) started in the first week in 51% of patients with 42% mortality, in 13% during the second week with 46% mortality and in 36% after the second week with 29% mortality. Mortality in patients with persistent multiple organ failure lasting <1 week, 1-2 weeks, 2-3 weeks or longer than 3 weeks was 43%, 38%, 46% and 52%, respectively (p=0.68). Mortality was higher in patients with organ failure alone than in patients with organ failure and infected pancreatic necrosis (44% vs 29%, p=0.04). However, when excluding patients with very early mortality (within 10 days of admission), patients with organ failure with or without infected pancreatic necrosis had similar mortality rates (28% vs 34%, p=0.33)., Conclusion: In patients with necrotising pancreatitis, early persistent organ failure is not associated with increased mortality when compared with persistent organ failure which develops further on during the disease course. Furthermore, no association was found between the duration of organ failure and mortality., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Interpretation of randomized controlled trials (RCTs) without a significant difference regarding the primary outcome (negative RCTs) is frequently challenging, due to concerns about sample size and thus sufficient statistical power. We aimed to assess the adequacy of sample size and corresponding power of surgical RCTs., Methods: We previously identified all surgical RCTs available in PubMed in two distinct years a decade apart (1999 and 2009). For all "negative" trials, we estimated whether the sample size of the trial was appropriate to detect a difference in the primary outcome measure. The main outcome measure was a sufficient sample size to detect large, medium, and small treatment effects. We also performed a post hoc power analysis based on the actual observed effect difference., Results: A total of 228 negative RCTs (74 in 1999 and 121 in 2009) were included. The median sample size was 76 (± 222) and 80 (± 163) in 1999 and 2009, respectively. Sample size calculation was increasingly reported from 40% in 1999 to 54% in 2009 (P = 0.02). The proportion of studies adequately powered to detect large (57% versus 68%), medium (26% versus 25%), or small (8% versus 7%) differences did not differ significantly between 1999 and 2009, respectively. To reach sufficient power, the required increases in sample size were 130%, 240%, and 1032% for large, medium, and small differences, respectively. Reporting a sample size calculation was the only independent predictor for adequate power., Conclusions: Despite slight improvement in the reporting of a sample size calculation, about a third of surgical trials remains underpowered to demonstrate differences that are likely to be clinically significant. Increased attention of researchers, medical ethical boards, and journal editors is required to reduce potentially wasted resources on underpowered trials., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: Implant-related irritation at the entry site is a known disadvantage of intramedullary nailing for clavicle fractures. The purpose of this study was to compare implant-related irritation rates of intramedullary nailing with or without an end cap for displaced midshaft clavicle fractures., Methods: Two cohorts of patients treated with intramedullary nailing with or without an end cap were matched and compared. Primary outcome was patient-reported implant-related irritation. Secondary outcome parameters were complications., Results: A total of 34 patients with an end cap were matched with 68 patients without an end cap. There was no difference in implant-related irritation (41 versus 53%, P = 0.26). Significantly more minor revisions were observed in the group without an end cap (15 versus 0%, P = 0.03). For complications requiring major revision surgery, significantly more implant failures were observed in the end cap group (12 versus 2%, P = 0.04). Regardless of their treatment, patients with complex fractures (AO/OTA B2-B3) reported significantly more medial irritation compared to patients with simple fractures (AO/OTA B1)(P = 0.02)., Conclusion: The use of an end cap after intramedullary nailing for displaced midshaft clavicle fractures did not result in lower patient-reported irritation rates. Although less minor revisions were observed, more major revisions were reported in the end cap group. Based on the results of this study, no end caps should be used after intramedullary nailing for displaced midshaft clavicle fractures. However, careful selection of simple fractures might be effective in reducing implant-related problems after intramedullary nailing.

Purpose: The journal impact factor (IF) is often used as a surrogate marker for methodological quality. The objective of this study is to evaluate the relation between the journal IF and methodological quality of surgical randomized controlled trials (RCTs)., Methods: Surgical RCTs published in PubMed in 1999 and 2009 were identified. According to IF, RCTs were divided into groups of low (<2), median (2-3) and high IF (>3), as well as into top-10 vs all other journals. Methodological quality characteristics and factors concerning funding, ethical approval and statistical significance of outcomes were extracted and compared between the IF groups. Additionally, a multivariate regression was performed., Results: The median IF was 2.2 (IQR 2.37). The percentage of 'low-risk of bias' RCTs was 13% for top-10 journals vs 4% for other journals in 1999 (P < 0.02), and 30 vs 12% in 2009 (P < 0.02). Similar results were observed for high vs low IF groups. The presence of sample-size calculation, adequate generation of allocation and intention-to-treat analysis were independently associated with publication in higher IF journals; as were multicentre trials and multiple authors., Conclusion: Publication of RCTs in high IF journals is associated with moderate improvement in methodological quality compared to RCTs published in lower IF journals. RCTs with adequate sample-size calculation, generation of allocation or intention-to-treat analysis were associated with publication in a high IF journal. On the other hand, reporting a statistically significant outcome and being industry funded were not independently associated with publication in a higher IF journal.

Objectives: This study aims to compare the M-ANNHEIM, Büchler, and Lüneburg diagnostic tools for chronic pancreatitis (CP)., Methods: A cross-sectional analysis of the development of CP was performed in a prospectively collected multicenter cohort including 669 patients after a first episode of acute pancreatitis. We compared the individual components of the M-ANNHEIM, Büchler, and Lüneburg tools, the agreement between tools, and estimated diagnostic accuracy using Bayesian latent-class analysis., Results: A total of 669 patients with acute pancreatitis followed-up for a median period of 57 (interquartile range, 42-70) months were included. Chronic pancreatitis was diagnosed in 50 patients (7%), 59 patients (9%), and 61 patients (9%) by the M-ANNHEIM, Lüneburg, and Büchler tools, respectively. The overall agreement between these tools was substantial (κ = 0.75). Differences between the tools regarding the following criteria led to significant changes in the total number of diagnoses of CP: abdominal pain, recurrent pancreatitis, moderate to marked ductal lesions, endocrine and exocrine insufficiency, pancreatic calcifications, and pancreatic pseudocysts. The Büchler tool had the highest sensitivity (94%), followed by the M-ANNHEIM (87%), and finally the Lüneburg tool (81%)., Conclusions: Differences between diagnostic tools for CP are mainly attributed to presence of clinical symptoms, endocrine insufficiency, and certain morphological complications.

Objective: Acute pancreatitis may be the first manifestation of pancreatic cancer. The aim of this study was to assess the risk of pancreatic cancer after a first episode of acute pancreatitis., Methods: Between March 2004 and March 2007, all consecutive patients with a first episode of acute pancreatitis were prospectively registered. Follow-up was based on hospital records audit, radiological imaging, and patient questionnaires. Outcome was stratified based on the development of chronic pancreatitis., Results: We included 731 patients. The median follow-up time was 55 months. Progression to chronic pancreatitis was diagnosed in 51 patients (7.0%). In this group, the incidence rate per 1000 person-years for developing pancreatic cancer was 9.0 (95% confidence interval, 2.3-35.7). In the group of 680 patients who did not develop chronic pancreatitis, the incidence rate per 1000 person-years for developing pancreatic cancer in this group was 1.1 (95% confidence interval, 0.3-3.3). Hence, the rate ratio of pancreatic cancer was almost 9 times higher in patients who developed chronic pancreatitis compared with those who did not (P = 0.049)., Conclusions: Although a first episode of acute pancreatitis may be related to pancreatic cancer, this risk is mainly present in patients who progress to chronic pancreatitis.

Introduction: Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols., Methods: A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty., Results: The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40-0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09-3.45, p = 0.02)., Conclusion: Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology.

Background: Bioactive coils were introduced in 2002 in an attempt to improve aneurysm healing and durability of angiographic results. Evidence demonstrating superior efficacy to justify the routine use of bioactive coils over bare coils is limited. We compared the periprocedural and clinical outcome after bioactive and bare platinum coiling for intracranial aneurysms., Methods: MEDLINE, EMBASE, Cochrane Library, and ISI Web of Knowledge Conference Proceedings Citation Index-Science were searched for randomized clinical trials (RCTs) comparing bioactive and bare coils. The methodological quality was evaluated to assess bias risk. Periprocedural outcomes and mid-term outcomes were compared., Results: Five independent RCTs comparing bioactive (n=1084) and bare coils (n=1084) were identified. Periprocedural outcome was similar for both groups. Bioactive coiling increased the rate of complete aneurysm occlusion (47% vs 40%; RR 1.17 (95% CI 1.05 to 1.31); p=0.006) and reduced the rate of residual aneurysm neck at 10 months compared with bare coiling in the mid-term (26% vs 31%; RR 0.82 (95% CI 0.70 to 0.96); p=0.01). There were no differences in aneurysm recurrence, aneurysm rupture, stroke, neurological death, modified Rankin Scale score and reinterventions. Subgroup analysis for the three RCTs on hydrogel coils demonstrated reduction of residual aneurysms compared with bare coiling (25% vs 34%; RR 0.76 (95% CI 0.58 to 0.99); p=0.04)., Conclusions: Bioactive coils ensure a higher rate of medium-term complete aneurysm occlusion while reducing the rate of residual neck aneurysms compared with bare coiling in the mid-term. Hydrogel coils reduce residual aneurysms compared with bare coils. While there is level 1a evidence to show more complete aneurysm occlusion, longer term follow-up is needed to determine if this translates into clinical significance., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Calcineurin inhibitors are alternatives to corticosteroid for treatment of atopic dermatitis., Objectives: We sought to compare the beneficial effects and adverse events associated with these therapies in treating patients with atopic dermatitis., Methods: Four databases were searched for randomized clinical trials comparing topical calcineurin inhibitors versus corticosteroids in children and adults. Methodological quality was evaluated to assess bias risk. Clinical outcome and costs were compared., Results: Twelve independent randomized clinical trials comparing calcineurin inhibitors (n = 3492) versus corticosteroids (n = 3462) were identified. Calcineurin inhibitors and corticosteroids had similar rates of improvement of dermatitis (81% vs 71%; risk ratio [RR] 1.18; 95% confidence interval [CI] 1.04-1.34; P = .01) and treatment success (72% vs 68%; RR 1.15; 95% CI 1.00-1.31; P = .04). Calcineurin inhibitors were associated with higher costs and had more adverse events (74% vs 64%; RR 1.28; 95% CI 1.05-1.58; P = .02) including a higher rate of skin burning (30% vs 9%; RR 3.27; 95% CI 2.48-4.31; P < .00001) and pruritus (12% vs 8%; RR 1.49; 95% CI 1.24-1.79; P < .00001). There were no differences in atrophy, skin infections, or adverse events that were serious or required discontinuation of therapy., Limitations: Only a small number of trials reported costs., Conclusion: Calcineurin inhibitors and corticosteroids have similar efficacy. Calcineurin inhibitors are associated with higher costs and have more adverse events, such as skin burning and pruritus. These results provide level-1a support for the use of corticosteroids as the therapy of choice for atopic dermatitis., (Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The last decade has shown a shift toward operative treatment of a subset of midshaft clavicle fractures. However, it is unclear whether there are differences between plate fixation and intramedullary fixation regarding complications and functional outcome. The aim of this systematic review and meta-analysis was to compare plate fixation and intramedullary fixation for midshaft clavicle fractures., Methods: The Medline, Embase, and Cochrane databases were searched for both randomized controlled trials and observational studies. The methodologic quality of all included studies was assessed using the Methodological Index for Non-Randomized Studies., Results: Twenty studies were included. Ten of the 20 included studies used a fracture classification. Seven of these studies reported exclusion of patients with comminuted fractures. No difference in the total re-intervention rate was found (odds ratio [OR], 1.21; 95% confidence interval [CI], 0.71 to 2.04). Major re-interventions occurred more often after plate fixation (OR, 1.88; 95% CI, 1.02 to 3.46). The mean implant removal rates were 38% after plate fixation and 73% after intramedullary fixation. Re-fracture after implant removal occurred more often after plate fixation (OR, 3.42; 95% CI, 1.12 to 10.42). The Constant-Murley scores showed no differences at both short term (mean difference, -1.18; 95% CI, -13.41 to 11.05) and long term (mean difference, 0.15; 95% CI, -1.57 to 1.87). No differences were observed regarding nonunion (OR, 1.50; 95% CI, 0.82 to 2.75). The rate of infections showed no differences when outlier studies were excluded (OR, 1.54; 95% CI, 0.88 to 2.69)., Conclusion: Major re-intervention and re-fracture after implant removal occurred more frequently after plate fixation of non-comminuted, displaced midshaft clavicle fractures. No differences in terms of function and nonunion between plate fixation and intramedullary fixation were observed., (Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Patients with a first episode of acute pancreatitis can develop recurrent or chronic pancreatitis (CP). However, little is known about the incidence or risk factors for these events., Methods: We performed a cross-sectional study of 669 patients with a first episode of acute pancreatitis admitted to 15 Dutch hospitals from December 2003 through March 2007. We collected information on disease course, outpatient visits, and hospital readmissions, as well as results from imaging, laboratory, and histology studies. Standardized follow-up questionnaires were sent to all available patients to collect information on hospitalizations and interventions for pancreatic disease, abdominal pain, steatorrhea, diabetes mellitus, medications, and alcohol and tobacco use. Patients were followed up for a median time period of 57 months. Primary end points were recurrent pancreatitis and CP. Risk factors were evaluated using regression analysis. The cumulative risk was assessed using Kaplan-Meier analysis., Results: Recurrent pancreatitis developed in 117 patients (17%), and CP occurred in 51 patients (7.6%). Recurrent pancreatitis developed in 12% of patients with biliary disease, 24% of patients with alcoholic etiology, and 25% of patients with disease of idiopathic or other etiologies; CP occurred in 3%, 16%, and 10% of these patients, respectively. Etiology, smoking, and necrotizing pancreatitis were independent risk factors for recurrent pancreatitis and CP. Acute Physiology and Chronic Health Evaluation II scores at admission also were associated independently with recurrent pancreatitis. The cumulative risk for recurrent pancreatitis over 5 years was highest among smokers at 40% (compared with 13% for nonsmokers). For alcohol abusers and current smokers, the cumulative risks for CP were similar-approximately 18%. In contrast, the cumulative risk of CP increased to 30% in patients who smoked and abused alcohol., Conclusions: Based on a retrospective analysis of patients admitted to Dutch hospitals, a first episode of acute pancreatitis leads to recurrent pancreatitis in 17% of patients, and almost 8% of patients progress to CP within 5 years. Progression was associated independently with alcoholic etiology, smoking, and a history of pancreatic necrosis. Smoking is the predominant risk factor for recurrent disease, whereas the combination of alcohol abuse and smoking produces the highest cumulative risk for chronic pancreatitis., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Introduction: At least 30% of patients with infected necrotizing pancreatitis are successfully treated with catheter drainage alone. It is currently not possible to predict which patients also need necrosectomy. We evaluated predictive factors for successful catheter drainage., Methods: This was a post hoc analysis of 130 prospectively included patients undergoing catheter drainage for (suspected) infected necrotizing pancreatitis. Using logistic regression, we evaluated the association between success of catheter drainage (ie, survival without necrosectomy) and 22 factors regarding demographics, disease severity (eg, Acute Physiology And Chronic Health Evaluation II score, organ failure), and morphologic characteristics on computed tomography (eg, percentage of necrosis)., Results: Catheter drainage was performed percutaneously in 113 patients and endoscopically in 17 patients. Infected necrosis was confirmed in 116 patients (89%). Catheter drainage was successful in 45 patients (35%). In multivariable regression, the following factors were associated with a reduced chance of success: male sex [odds ratio (OR) = 0.27; 95% confidence interval (CI): 0.09-0.55; P <0.01), multiple organ failure (OR = 0.15; 95% CI: 0.04-0.62; P < 0.01), percentage of pancreatic necrosis (<30%/30%-50%/>50%: OR = 0.54; 95% CI: 0.30-0.96; P = 0.03), and heterogeneous collection (OR = 0.21; 95% CI: 0.06-0.67; P < 0.01). A prediction model incorporating these factors demonstrated an area under the receiver operating characteristic curve of 0.76. A prognostic nomogram yielded success probability of catheter drainage from 2% to 91%., Conclusions: Male sex, multiple organ failure, increasing percentage of pancreatic necrosis and heterogeneity of the collection are negative predictors for success of catheter drainage in infected necrotizing pancreatitis. The constructed nomogram can guide prognostication in clinical practice and risk stratification in clinical studies.

Background: Endoscopy and surgery are the treatment modalities of choice for patients with chronic pancreatitis and dilated pancreatic duct (obstructive chronic pancreatitis). Physicians face, without clear consensus, the choice between endoscopy or surgery for this group of patients., Objectives: To assess and compare the effects and complications of surgical and endoscopic interventions in the management of pain for obstructive chronic pancreatitis., Search Methods: We searched the following databases in The Cochrane Library: CENTRAL (2014, Issue 2), the Cochrane Database of Systematic Reviews (2014, Issue 2), and DARE (2014, Issue 2). We also searched the following databases up to 25 March 2014: MEDLINE (from 1950), Embase (from 1980), and the Conference Proceedings Citation Index - Science (CPCI-S) (from 1990). We performed a cross-reference search. Two review authors independently performed the selection of trials., Selection Criteria: All randomised controlled trials (RCTs) of endoscopic or surgical interventions in obstructive chronic pancreatitis. We included trials comparing endoscopic versus surgical interventions as well as trials comparing either endoscopic or surgical interventions to conservative treatment (i.e. non-invasive treatment modalities). We included relevant trials irrespective of blinding, the number of participants randomised, and the language of the article., Data Collection and Analysis: We used standard methodological procedures expected by The Cochrane Collaboration. Two authors independently extracted data from the articles. We evaluated the methodological quality of the included trials and requested additional information from study authors in the case of missing data., Main Results: We identified three eligible trials. Two trials compared endoscopic intervention with surgical intervention and included a total of 111 participants: 55 in the endoscopic group and 56 in the surgical group. Compared with the endoscopic group, the surgical group had a higher proportion of participants with pain relief, both at middle/long-term follow-up (two to five years: risk ratio (RR) 1.62, 95% confidence interval (CI) 1.22 to 2.15) and long-term follow-up (≥ five years, RR 1.56, 95% CI 1.18 to 2.05). Surgical intervention resulted in improved quality of life and improved preservation of exocrine pancreatic function at middle/long-term follow-up (two to five years), but not at long-term follow-up (≥ 5 years). No differences were found in terms of major post-interventional complications or mortality, although the number of participants did not allow for this to be reliably evaluated. One trial, including 32 participants, compared surgical intervention with conservative treatment: 17 in the surgical group and 15 in the conservative group. The trial showed that surgical intervention resulted in a higher percentage of participants with pain relief and better preservation of pancreatic function. The trial had methodological limitations, and the number of participants was relatively small., Authors' Conclusions: For patients with obstructive chronic pancreatitis and dilated pancreatic duct, this review shows that surgery is superior to endoscopy in terms of pain relief. Morbidity and mortality seem not to differ between the two intervention modalities, but the small trials identified do not provide sufficient power to detect the small differences expected in this outcome.Regarding the comparison of surgical intervention versus conservative treatment, this review has shown that surgical intervention in an early stage of chronic pancreatitis is a promising approach in terms of pain relief and pancreatic function. Other trials need to confirm these results because of the methodological limitations and limited number of participants assessed in the present evidence.

Background: Chronic pancreatitis is a complex disease with many unanswered questions regarding the natural history and therapy. Prospective longitudinal studies with long-term follow-up are warranted., Methods: The Dutch Chronic Pancreatitis Registry (CARE) is a nationwide registry aimed at prospective evaluation and follow-up of patients with chronic pancreatitis. All patients with (suspected) chronic or recurrent pancreatitis are eligible for CARE. Patients are followed-up by yearly questionnaires and review of medical records. Study outcomes are pain, disease complications, quality of life, and pancreatic function. The target sample size was set at 500 for the first year and 1000 patients within 3 years., Results: A total of 1218 patients were included from February 2010 until June 2013 by 76 participating surgeons and gastroenterologist from 33 hospitals. Participation rate was 90% of eligible patients. Eight academic centers included 761 (62%) patients, while 25 community hospitals included 457 (38%). Patient centered outcomes were assessed by yearly questionnaires, which had a response rate of 85 and 82% for year 1 and 2, respectively. The median age of patients was 58 years, 814 (67%) were male, and 38% had symptoms for less than 5 years., Discussion: The CARE registry has successfully recruited over 1200 patients with chronic and recurrent pancreatitis in about 3 years. The defined inclusion criteria ensure patients are included at an early disease stage. Participation and compliance rates are high. CARE offers a unique opportunity with sufficient power to investigate many clinical questions regarding natural course, complications, and efficacy and timing of treatment strategies., (Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.)

Background: Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections, but evidence to support this strategy is limited. We conducted a multicenter, randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis., Methods: We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher (on a scale of 0 to 71, with higher scores indicating more severe disease), an Imrie or modified Glasgow score of 3 or higher (on a scale of 0 to 8, with higher scores indicating more severe disease), or a serum C-reactive protein level of more than 150 mg per liter. Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization (early group) or to an oral diet initiated 72 hours after presentation (on-demand group), with tube feeding provided if the oral diet was not tolerated. The primary end point was a composite of major infection (infected pancreatic necrosis, bacteremia, or pneumonia) or death during 6 months of follow-up., Results: A total of 208 patients were enrolled at 19 Dutch hospitals. The primary end point occurred in 30 of 101 patients (30%) in the early group and in 28 of 104 (27%) in the on-demand group (risk ratio, 1.07; 95% confidence interval, 0.79 to 1.44; P=0.76). There were no significant differences between the early group and the on-demand group in the rate of major infection (25% and 26%, respectively; P=0.87) or death (11% and 7%, respectively; P=0.33). In the on-demand group, 72 patients (69%) tolerated an oral diet and did not require tube feeding., Conclusions: This trial did not show the superiority of early nasoenteric tube feeding, as compared with an oral diet after 72 hours, in reducing the rate of infection or death in patients with acute pancreatitis at high risk for complications. (Funded by the Netherlands Organization for Health Research and Development and others; PYTHON Current Controlled Trials number, ISRCTN18170985.).

Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current gold standard in the surgical treatment of ulcerative colitis (UC) refractory to medical management. A procedure of significant magnitude carries its own risks including anastomotic failure, pelvic sepsis and a low rate of neoplastic degeneration overtime. Recent studies have shown that total colectomy with ileorectal anastomosis (IRA) has been associated with good long-term functional results in a selected group of UC patients amenable to undergo a strict surveillance for the relatively high risk of cancer in the rectum. This manuscript will review and compare the most recent literature on IRA and IPAA as it pertains to postoperative morbidity and mortality, failure rates, functional outcomes and cancer risk.

Background: The aim of this study was to determine factors associated with deviation in length of hospital stay (LOS) from that determined by diagnosis-related groups., Methods: A cohort study from a prospectively collected database was conducted, including consecutive patients undergoing surgery in a high-volume colorectal surgery department in 2009., Results: For 1,461 included patients, average expected and actual LOS were 8.17 days (interquartile range, 4.7 to 11.9 days) and 8.31 days (interquartile range, 4 to 10 days), respectively. The most prominent factors associated with an increase of LOS from expected were parenteral nutrition (5.11 days), emergency room admittance (3.67 days), and ileus (3.45 days) (P ≤ .001 for all). Other independently associated factors included blood transfusion, anastomotic leak, sepsis, pulmonary embolism, and surgeon. Patients with higher severity illness indexes and longer postoperative intensive care stay had lower than expected LOS., Conclusions: After colorectal surgery, several modifiable factors are associated with deviation of LOS from expected. An opportunity hence exists to reduce both LOS and financial burden for hospitals in an era of pay for performance., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Reduced intake and absorption of antioxidants due to pain and malabsorption are probable causes of the lower levels of antioxidants observed in patients with chronic pancreatitis (CP). Improving the status of antioxidants might be effective in slowing the disease process and reducing pain in CP., Objectives: To assess the benefits and harms of antioxidants for the treatment of pain in patients with CP., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Conference Proceedings Citation Index from inception to October 2012. Two review authors performed the selection of trials independently., Selection Criteria: We included all randomised controlled trials (RCTs) evaluating antioxidants for treatment of pain in CP. All trials were included irrespective of blinding, numbers of participants randomly assigned and language of the article., Data Collection and Analysis: Two review authors extracted data independently. The risk of bias of included trials was assessed. Study authors were asked for additional information in the case of missing data., Main Results: Twelve RCTs with a total of 585 participants were included. Six trials were double-blinded, placebo-controlled studies, and the other six trials were of less adequate methodology. Most trials were small and had high rates of dropout. Eleven of the 12 included trials described the effects of antioxidants on chronic abdominal pain in chronic pancreatitis. Pain as measured on a visual analogue scale (VAS, scale range 0 to 10) after one to six months was less in the antioxidant group than in the control group (mean difference (MD) -0.33, 95% confidence interval (CI) -0.64 to -0.02, P value 0.04, moderate-quality evidence). The number of pain-free participants was not statistically significantly different (risk ratio (RR) 1.73, 95% CI 0.95 to 3.15, P value 0.07, low-quality evidence). More adverse events were observed in the antioxidant group, both in the parallel trials (RR 4.43, 95% CI 1.60 to 12.29, P value 0.0004, moderate-quality evidence) and in the cross-over trials (RR 5.80, 95% CI 1.56 to 21.53, P value 0.0009, moderate-quality evidence). Adverse events occurred in 16% of participants and were mostly mild (e.g. headache, gastrointestinal complaints), but were sufficient to make participants stop antioxidant use. Other important outcomes such as use of analgesics, exacerbation of pancreatitis and quality of life were rarely reported. One trial from 1991 evaluated the effects of antioxidants on acute pain during exacerbation of chronic pancreatitis and found that a significantly higher proportion of participants in the antioxidant group experienced pain relief. This trial was conducted more than 25 years ago and has not been reproduced since that time. Therefore, additional trials are needed before reliable conclusions can be drawn., Authors' Conclusions: Current evidence shows that antioxidants can reduce pain slightly in patients with chronic pancreatitis. The clinical relevance of this small reduction is uncertain, and more evidence is needed. Adverse events in one of six patients may prevent the use of antioxidants. Effects of antioxidants on other outcome measures, such as use of analgesics, exacerbation of pancreatitis and quality of life remain uncertain because reliable data are not available.

Background: Immunosuppressive agents are essential in the management of Crohn's disease. Their safety before surgery, however, is still controversial., Objective: The aim of this study is to evaluate whether the preoperative use of immunosuppressive agents is associated with increased postoperative complications in Crohn's disease., Data Sources: A literature search of PubMed, EMBASE, and The Cochrane Library was undertaken in February 2013., Study Selection: All studies describing postoperative outcomes of patients undergoing bowel resections for Crohn's disease were included if they reported data comparing patients on preoperative immunosuppressive agents with an appropriate control group., Interventions: All immunosuppressive agents used to manage Crohn's disease were studied., Main Outcome Measures: The main outcomes measured were total overall complications and total infectious complications., Results: Twenty-one eligible studies (20 retrospective and 1 prospective) with 6899 patients were included. When individual studies were examined, only 2/14 (14%), 4/13 (31%), and 1/8 (13%) studies found an association between postoperative complications and preoperative anti-tumor necrosis factor agents, corticosteroids, and thiopurines. In meta-analyses, patients on anti-tumor necrosis factor agents (risk ratio, 1.29; 95% CI, 1.07-1.55), and corticosteroids (risk ratio, 1.55; 95% CI, 1.23-1.95) were found to have a higher risk of postoperative infectious complications. The use of anti-tumor necrosis factor agents was also significantly associated with wound infection (risk ratio, 1.62; 95% CI, 1.12-2.34) and septic shock (risk ratio, 1.81; 95% CI, 1.03-3.17). There was no association between the use of thiopurines or combined immunomodulator drugs and postoperative complications., Limitations: Most studies were retrospectively designed, and there were large variations in the patient populations and outcome definitions., Conclusions: Patients with Crohn's disease on preoperative immunosuppressive agents are at higher risk for complications. Both corticosteroids and anti-tumor necrosis factor agents may increase the risk of infections and septic shock. A preoperative drug-free interval, when feasible, might be considered to reduce the risk of infections. The adoption of any operative strategies that modify these outcomes may additionally counter these risks.

Objective: To evaluate the influence of preoperative dysplasia grade, appearance, and site on risk and location of cancer in patients with colitis., Background: The ability to predict the presence and location of cancer in colitis patients with dysplasia is essential to facilitate recommendations regarding the necessity and type of surgery., Methods: Ulcerative and indeterminate colitis patients who underwent proctocolectomy for dysplasia were retrospectively selected. Patient characteristics and findings at colonoscopic surveillance were associated with findings on the surgical specimen by regression analysis., Results: From 1984 to 2007, 348 proctocolectomy specimens with preoperative dysplasia showed cancer in 51 (15%) and dysplasia in 172 (49%) cases. Patients with preoperative high-grade dysplasia (HGD) had cancer in 29% compared with 3% in low-grade dysplasia (LGD) (P < 0.001). Patients with preoperative dysplasia-associated lesion/mass (DALM) had cancer in 25% compared with 8% in flat dysplasia (P < 0.001). In LGD with DALM, the risk of cancer was not significantly higher than in flat LGD (7% vs 2%, P = 0.3), but risk of cancer or HGD was higher with a threefold increase (29% vs 9%, P = 0.015). On multivariate analysis, HGD, DALM, and disease duration were independent risk factors for postoperative cancer. In patients with isolated colonic dysplasia above the sigmoid level, postoperative rectal involvement was limited., Conclusions: Risk of cancer for patients with HGD or DALM is substantial. Despite low risk of cancer in patients with flat LGD, threshold for surgery should be low given the high prevalence of postoperative pathologic findings. Only in selected cases, colonoscopic surveillance after discussion of associated risks may be acceptable, provided high patient compliance can be assured. Surgery should be considered in all other cases, because it is the only modality that can eliminate the risk of cancer. The location of preoperative dysplasia may allow for the clarification of the need for proctectomy especially in the poor risk surgical patient.

Background: Thoracoscopic splanchnicectomy (TS) is a minimally invasive intervention to relieve pain in patients with chronic pancreatitis (CP) with equivocal results. Preoperative opioid use seems to impair TS outcome but this has not been investigated in a systematic matter., Methods: We searched PubMed, EMBASE, and The Cochrane Library for studies on the outcome of TS in CP patients. Studies with ≥5 patients and a follow-up of ≥12 months were included. Success was defined as the proportion of patients free of opioids or who had a reduction of ≥4 points on a pain scale. The effect of opioid use on the success rate of TS was analyzed by uni- and multivariate regression., Results: Sixteen studies with 484 patients were included in our review. The mean (±SD) age of the patients was 44 ± 4.3 years and 66 % were male. Median follow-up period was 21 months (IQR 14-35). Median preoperative opioid use was 85 % (IQR 54-100 %). After TS, a median of 49 % (IQR 22-75 %) of patients were free of opioids at end of follow-up. The median success rate was 62 % (IQR 48-86 %). Mean success rate in studies in which ≤50 % of the patients used opioids preoperatively was 81 % (SD ± 21) compared to 60 % (SD ± 15) for other studies (p = 0.049). Higher age, male gender, and lower rates of preoperative opioid use were associated with a higher success rate (p = 0.003, 0.047, and 0.017, respectively). Multivariate regression, including age, gender, preoperative opioid use, and duration of follow-up, identified age and preoperative opioid use as independent predictors of success after TS (both p = 0.002)., Conclusion: Preoperative opioid use is associated with a worse outcome after TS in CP patients. To optimize outcome, use of TS may be considered at an earlier stage in the treatment of patients with CP before prolonged opioid therapy.

For new interventions, the results of sequential randomized or non-randomized trials and meta-analysis can differ significantly. Evaluation of the evidence for the effect of a new treatment is a complex interplay of several factors, including the methodological design, the risk of a coincidental finding and applicability in practice. For proper appraisal of the design of trials, the use of aggregate scores should be avoided and individual study limitations should be mentioned. With the use of additional analyses we can now test whether meta-analyses contain sufficient data to find potentially relevant differences. The new 'Grading of recommendations assessment, development and evaluation' (GRADE) system is a consensus guideline that combines multiple factors into an easily interpreted judgment of the strength of evidence. Concise presentation of important quality factors for each outcome significantly increases clarity. A more realistic assessment of the reliability of the evidence decreases the risk of major fluctuations in treatment policy.

Background: Chronic abdominal pain is common in chronic pancreatitis (CP) and may involve altered central pain processing. This study evaluated the relationship between pain processing and pain outcome after pancreatic duct decompression and/or pancreatic resection in patients with CP., Methods: Patients with CP underwent quantitative sensory testing. Pain processing was measured via electrical pain detection (ePDT) and electrical pain tolerance (ePTT) thresholds in dermatomes C5 and L4. Inhibitory descending pain control mechanisms were assessed using the conditioned pain modulation (CPM) paradigm. Healthy controls and patients with CP were compared, and patients with CP and a poor pain outcome (visual analogue scale (VAS) score greater than 30) were compared with those with a good pain outcome (VAS score 30 or less)., Results: Forty-eight patients with CP had lower ePDT, ePTT and CPM responses compared with values in 15 healthy controls (P < 0·030). The sum of ePDT values was lower in patients with a poor pain outcome than in those with a good outcome (median 7·1 versus 11·2 mA; P = 0·008). There was a correlation with the VAS score and the sum of ePDT values (rs  = -0·45, P = 0·016) and ePTT values (rs  = -0·46, P = 0·011), and CPM response (rs  = -0·43, P = 0·006) in patients with CP., Conclusion: After pain-relieving pancreatic surgery, patients with CP exhibit altered central pain processing compared with that in healthy controls. Poor pain outcomes are associated with more central sensitization and more pronociceptive descending pain modulation, and this should be considered when managing persistent pain after pain-relieving surgery for CP., (© 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd.)

Objective: In the revised Atlanta classification of acute pancreatitis, the term necrotising pancreatitis also refers to patients with only extrapancreatic fat necrosis without pancreatic parenchymal necrosis (EXPN), as determined on contrast-enhanced CT (CECT). Patients with EXPN are thought to have a better clinical outcome, although robust data are lacking., Methods: A post hoc analysis was performed of a prospective multicentre database including 639 patients with necrotising pancreatitis on contrast-enhanced CT. All CECT scans were reviewed by a single radiologist blinded to the clinical outcome. Patients with EXPN were compared with patients with pancreatic parenchymal necrosis (with or without extrapancreatic necrosis). Outcomes were persistent organ failure, need for intervention and mortality. A predefined subgroup analysis was performed on patients who developed infected necrosis., Results: 315 patients with EXPN were compared with 324 patients with pancreatic parenchymal necrosis. Patients with EXPN less often suffered from complications: persistent organ failure (21% vs 45%, p<0.001), persistent multiple organ failure (15% vs 36%, p<0.001), infected necrosis (16% vs 47%, p<0.001), intervention (18% vs 57%, p<0.001) and mortality (9% vs 20%, p<0.001). When infection of extrapancreatic necrosis developed, outcomes between groups were equal (mortality with infected necrosis: EXPN 28% vs pancreatic necrosis 18%, p=0.16)., Conclusion: EXPN causes fewer complications than pancreatic parenchymal necrosis. It should therefore be considered a separate entity in acute pancreatitis. Outcome in cases of infected necrosis is similar.

Objective: To assess worldwide trends in volume and methodological quality of published surgical randomized controlled trials (RCTs) over the past decade., Background: Randomized controlled trials are essential for clinical decision making. It has repeatedly been suggested that surgical RCTs are scarce and of mediocre quality., Methods: We systematically searched PubMed for surgical RCTs published in 1999 and 2009. Characteristics and risks of bias were extracted. Trials where compared between study years and geographical regions. Primary outcome was "low risk of bias," defined by all of the following: adequate allocation generation and concealment, intention-to-treat analysis, and adequate dropout handling., Results: The volume of published surgical RCTs increased by 50%, from 300 in 1999 to 450 in 2009. Volume increased in Europe (27% increase), Asia/Oceania (160% increase), and Africa/South America (416% increase) but decreased in North America (23% decrease), although the United States remained the country with the highest number of published RCTs. In 2009, methodological quality of surgical trials improved in terms of sample size calculation, adequate generation of randomization sequence, concealment of randomization sequence, and use of intention-to-treat analysis as compared with 1999 (P < 0.001 for all). The proportion of low risk of bias trials increased from 6% to 14% (prevalence ratio 2.59; 95% confidence interval 1.55-4.32). In 2009, the highest proportion of low risk of bias trials was from Europe (23%), whereas the lowest was from Asia/Oceania (5%)., Conclusions: Volume and quality of surgical RCTs improved although striking differences exist between continents and countries. Structured education in trial methodology, enforced adherence to existing guidelines, and improved research infrastructure may guide further improvements.

Purpose: Neoadjuvant chemoradiation (NCRT) may be avoided in some patients with T3-staged rectal cancer undergoing radical resection. We aimed to evaluate the accuracy of endorectal ultrasound (ERUS) in the nodal staging of uT3 tumors and hence the decision for administration of NCRT., Methods: Patients with uT3-staged rectal cancer who underwent proctectomy were retrospectively identified. The accuracy of ERUS for detecting nodal involvement was determined for patients who did not undergo NCRT. In order to evaluate the impact of use of NCRT, oncologic outcomes, functional outcomes, and quality of life (QOL) were compared for patients who received NCRT (group A) and those who did not (group B)., Results: For 384 patients who were included, ERUS overstaging rate for nodal involvement was 6.3% while understaging rate was 23.2%. For the 289 patients in group A and 95 in group B, Kaplan-Meier analysis showed similar 5-year local recurrence rates (3.5%), overall survival (76.9 vs 75.6%), and disease-free survival (87.9 vs 88.1%). Node positivity on final pathology was however associated with worse 5-year local recurrence (9.3 vs 4.3%). For patients undergoing restorative resection, NCRT was associated with worse functional outcomes but QOL was similar., Conclusions: ERUS identification of nodal involvement used as a criterion for NCRT carries a greater risk for undertreatment than overtreatment. Undertreatment adversely affects oncologic outcomes. While there is functional impairment related to NCRT, its effect on QOL is non-significant. The decision for omitting neoadjuvant chemoradiation for uT3 rectal cancer should hence not be based on ERUS nodal staging alone.

Objective: To compare short- and long-term outcome after 180-degree laparoscopic anterior fundoplication (180-degree LAF) with laparoscopic Nissen fundoplication (LNF)., Summary of Background Data: LNF is currently the most frequently performed surgical therapy for gastroesophageal reflux disease. Alternatively, 180-degree LAF has been alleged to reduce troublesome dysphagia and gas-related symptoms, with similar reflux control., Methods: MEDLINE, EMBASE, Cochrane Library, and web of Knowledge CPCI-S were searched for randomized clinical trials comparing primary 180-degree LAF with LNF. The methodological quality was evaluated to assess bias risk. Primary outcomes were esophageal acid exposure, esophagitis, heartburn score, dilatation for dysphagia, modified Dakkak dysphagia score (0-45), and reoperation rate. Meta-analysis was conducted at 1 and 5 years., Results: Five distinct randomized clinical trials comparing 180-degree LAF (n = 227) with LNF (n = 231) were identified. At 1 year, the Dakkak dysphagia score [2.8 vs 4.8; weighted mean difference: -2.25; 95% confidence interval (CI): -2.66 to -1.83; P < 0.001], gas bloating [11% vs 18%; relative risk (RR) 0.59; 95% CI: 0.36-0.97; P = 0.04], flatulence (14% vs 25%; RR: 0.57; 95% CI: 0.35-0.91; P = 0.02), inability to belch (19% vs 31%; RR: 0.63; 95% CI: 0.40-0.99; P = 0.05), and inability to relieve bloating (34% vs 44%; RR: 0.74; 95% CI: 0.55-0.99; P = 0.04) were lower after 180-degree LAF. Esophageal acid exposure (standardized mean difference: 0.19; 95% CI: -0.07 to 0.46; P = 0.15), esophagitis (19% vs 13%; RR: 1.42; 95% CI: 0.69-2.91; P = 0.34), heartburn score (standardized mean difference: 1.27; 95% CI:-0.36 to 2.90; P = 0.13), dilatation rate (1.4% vs 2.8%; RR: 0.60; 95% CI: 0.19-1.91; P = 0.39), reoperation rate (5.7% vs 2.8%; RR: 2.08; 95% CI: 0.80-5.41; P = 0.13), perioperative outcome, regurgitation, proton pump inhibitor (PPI) use, lower esophageal sphincter pressure, and patient satisfaction were similar after 180-degree LAF and LNF. At 5 years, the Dakkak dysphagia score, flatulence, inability to belch, and inability to relieve bloating remained lower after 180-degree LAF. The 5-year heartburn score, dilatation rate, reoperation rate, PPI use, and patient satisfaction were similar., Conclusions: At 1 and 5 years, dysphagia and gas-related symptoms are lower after 180-degree LAF than after LNF, and esophageal acid exposure and esophagitis are similar, with no differences in heartburn scores, patient satisfaction, dilatations, and reoperation rate. These results lend level 1a support for the use of 180-degree LAF for the surgical treatment of gastroesophageal reflux disease.

Background: In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis., Methods/design: The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%)., Discussion: The ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice., Trial Registration: ISRCTN: ISRCTN45877994.

The current structure of residency training allows for safe participation of residents in the care of surgical patients. In part, this is likely due to the ability of attending-level surgeons and educators to adequately select and provide the supervision needed for different levels of residents. Nonetheless, efforts have to be made to ensure the optimal safety of patients in several settings of modern health care. For laparoscopic surgery, training and simulation are highly advisable in preparing residents to perform well in the early stage of their learning curves. Attention has to be given to safe and complete hand-offs, especially with the increased focus on restricting work hours and the increased number of changing shifts. Measures to ensure optimal preparation of surgical residents to perform well in stressful situations should also be taken, because such situations are an intrinsic part of this specialty. It is only by focusing on all these aspects that we can ensure the safety for our patients and provide the best possible training for the next generation of surgeons.

Objective: To evaluate the effect of timing of surgery on the long-term clinical outcome of surgery in chronic pancreatitis (CP)., Design: Cohort study with long-term follow-up., Setting: Five specialized academic centers., Patients: Patients with CP treated surgically for pain., Interventions: Pancreatic resection and drainage procedures for pain relief., Main Outcome Measures: Pain relief (pain visual analogue score ≤4), pancreatic function, and quality of life., Results: We included 266 patients with median follow-up of 62 months (interquartile range, 31-112). Results were presented as odds ratios (ORs)with 95% confidence intervals after correction for bias using bootstrap-corrected analysis. Pain relief was achieved in 149 patients (58%). Surgery within 3 years of symptoms was independently associated with more pain relief (OR, 1.8; 95% CI, 1.0-3.4; P = .03) and less endocrine pancreatic insufficiency (OR, 0.57; 95% CI, 0.33-0.96; P = .04). More pain relief was also observed in patients not taking opioids preoperatively (OR, 2.1; 95% CI, 1.2-4.0; P = .006) and who had 5 or fewer endoscopic treatments prior to surgery (OR, 2.5; 95% CI, 1.1-6.3; P = .04). The probability of achieving pain relief varied between 23% and 75%, depending on these risk factors., Conclusions: The timing of surgery is an important risk factor for clinical outcome in CP. Surgery may need to be considered at an earlier phase than it is now, preferably within 3 years of symptomatic CP. Likelihood of postoperative pain relief can be calculated on an individual basis using the presented nomogram.