Three-Year Outcomes of Oral Antibiotics vs Intravenous and Oral Antibiotics for Uncomplicated Acute Appendicitis: A Secondary Analysis of the APPAC II Randomized Clinical Trial.

Importance: Current short-term evidence has shown that uncomplicated acute appendicitis can be treated successfully with oral antibiotics alone, but longer-term results are lacking. Objective: To assess the treatment effectiveness of oral antibiotic monotherapy compared with combined intravenous (IV) and oral antibiotics in computed tomography-confirmed uncomplicated acute appendicitis at a longer-term follow-up. Design, Setting, and Participants: This secondary analysis of a predefined year 3 follow-up of the Appendicitis Acuta II (APPAC II) noninferiority, multicenter randomized clinical trial compared oral moxifloxacin with combined IV ertapenem plus oral levofloxacin and metronidazole for the treatment of uncomplicated acute appendicitis. The trial was conducted at 9 university and central hospitals in Finland from April 2017 to November 2018, with the last follow-up in November 2022. Participants included patients aged 18 to 60 years, who were randomized to receive either oral antibiotics monotherapy (n = 301) or combined IV and oral antibiotics (n = 298). Interventions: Antibiotics monotherapy consisted of oral moxifloxacin, 400 mg/d, for 7 days. Combined IV and oral antibiotics consisted of IV ertapenem sodium, 1 g/d, for 2 days plus oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 5 days. Main Outcomes and Measures: The primary end point was treatment success, defined as the resolution of acute appendicitis and discharge from hospital without the need for surgical intervention and no appendicitis recurrence at the year 3 follow-up evaluated using a noninferiority design. The secondary end points included late (after 1 year) appendicitis recurrence as well as treatment-related adverse events, quality of life, length of hospital stay, and length of sick leave, which were evaluated using a superiority design. Results: After exclusions, 599 patients (mean [SD] age, 36 [12] years; 336 males [56.1%]) were randomized; after withdrawal and loss to follow-up, 582 patients (99.8%) were available for the year 3 follow-up. The treatment success at year 3 was 63.4% (1-sided 95% CI, 58.8% to ∞) in the oral antibiotic monotherapy group and 65.2% (1-sided 95% CI, 60.5% to ∞) in the combined IV and oral antibiotics group. The difference in treatment success rate between the groups at year 3 was -1.8 percentage points (1-sided 95% CI, -8.3 percentage points to ∞; P = .14 for noninferiority), with the CI limit exceeding the noninferiority margin. There were no significant differences between groups in treatment-related adverse events, quality of life, length of hospital stay, or length of sick leave. Conclusions and Relevance: This secondary analysis of the APPAC II trial found a slightly higher appendectomy rate in patients who received oral antibiotic monotherapy; however, noninferiority of oral antibiotic monotherapy compared with combined IV and oral antibiotics could not be demonstrated. The results encourage future studies to assess oral antibiotic monotherapy as a viable treatment alternative for uncomplicated acute appendicitis. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961.

Standardized Assessment of Metabolic Bariatric Surgery Outcomes: Secondary Analysis of 2 Randomized Clinical Trials.

Importance: A standardized definition and reporting of metabolic bariatric surgery (MBS) outcomes is not available for actual clinical practice and science. Objective: To assess the feasibility of using a clinically relevant and feasible MBS outcome score (Swiss-Finnish Bariatric Metabolic Outcome Score [SF-BARI Score]). Design, Setting, and Participants: This assessment of a bariatric surgery outcome score is based on the secondary analysis of merged 5-year individual patient data (N = 457) of 2 large randomized clinical trials (Swiss SM-BOSS [Swiss Multicenter Bypass or Sleeve Study], conducted from January 2007 to November 2011, and Finnish SLEEVEPASS [Laparoscopic Gastric Bypass Vs Sleeve Gastrectomy to Treat Morbid Obesity], conducted from March 2008 until June 2010) that compared laparoscopic sleeve gastrectomy with laparoscopic Roux-en-Y gastric bypass in the treatment of severe obesity. This secondary analysis was performed from January 2022 to January 2023. Main Outcomes and Measures: The main outcome was the feasibility of the SF-BARI Score and the SF-BARI Score QOL (quality of life) as tools to assess MBS outcomes. The score includes percentage of total weight loss (%TWL), 4 obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidemia, and obstructive sleep apnea), complications, and QOL, if available. Results: Among the 457 included patients, 323 (70.7%) were female and 134 (29.3%) were male, and the mean (SD) age was 45.6 (10.7) years. Outcomes for the SF-BARI Score were available for 435 patients (95.2%) at 1 year and 398 patients (87.1%) at 5 years and for SF-BARI Score QOL in 289 (63.2%) patients at 1 year and 318 patients (69.6%) at 5 years. The SF-BARI Score was correlated with both the SF-BARI Score QOL (r = 0.96; 95% CI, 0.95-0.96; P < .001) and %TWL (r = 0.86; 95% CI, 0.84-0.89; P < .001) and with the Bariatric Analysis and Reporting Outcome System (r = 0.59; 95% CI, 0.51-0.65; P < .001). Score outcomes were categorized as excellent, very good, good, fair, and suboptimal response. There was a statistically significant difference in scores at 1 vs 5 years (4.0; 95% CI, 1.4-6.6; P = .003), and the gastric bypass group had a higher score compared with the sleeve gastrectomy group (7.4; 95% CI, 3.4-11.5; P < .001). Conclusions and Relevance: These findings indicate that this metabolic bariatric surgery outcome score is a simple, relevant, and feasible composite tool to define and measure MBS outcomes, enabling standardized reporting. Trial Registration: ClinicalTrials.gov Identifiers: NCT00356213 (SM-BOSS) and NCT00793143 (SLEEVEPASS).

Validation of the individualized metabolic surgery score for bariatric procedure selection in the merged data of two randomized clinical trials (SLEEVEPASS and SM-BOSS).

BACKGROUND: LSG and LRYGB are globally the most common bariatric procedures. IMS score categorizes T2D severity (mild, moderate, and severe) based on 4 independent preoperative predictors of long-term remission as follows: T2D duration, number of diabetes medications, insulin use, and glycemic control. IMS score has not been validated in a randomized patient cohort. OBJECTIVES: To assess the feasibility of individualized metabolic surgery (IMS) score in facilitating procedure selection between laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) for patients with severe obesity and type 2 diabetes (T2D). SETTING: Merged individual patient-level 5-year data of 2 large randomized clinical trials (SLEEVEPASS and SM-BOSS [Swiss Multicenter Bypass or Sleeve Study]). METHODS: IMS score was calculated for study patients and its performance was analyzed. RESULTS: One hundred thirty-nine out of 155 patients with T2D had available preoperative data to calculate IMS score as follows: mild stage (n = 41/139), moderate stage (n = 77/139), severe stage (n = 21/139). At 5 years, 135 (87.1%, 67 LSG/68 LRYGB) were available for follow-up and 121 patients had both pre- and postoperative data. Diabetes remission rates according to preoperative IMS score were as follows: mild stage 87.5% (n = 14/16) after LSG and 85.7% (n = 18/21) after LRYGB (P = .999), moderate stage 42.9% (n = 15/35) and 45.2% (n = 14/31) (P = .999), and severe stage 18.2% (n = 2/11) and 0% (n = 0/7) (P = .497), respectively. The T2D remission rate varied significantly between the stages as follows: mild versus moderate odds ratio (OR) 8.3 (95% CI, 2.8-24.0; P < .001), mild versus severe OR 52.2 (95% CI 9.0-302.3; P < .001), and moderate versus severe OR 6.3 (95% CI, 1.3-29.8; P = .020). CONCLUSIONS: In our study, remission rates of T2D were not statistically different after LSG and LRYGB among all patients and among patients with mild, moderate, and severe diabetes stratified by the IMS score. However, the study may be underpowered to detect differences due to small number of patients in each subgroup. IMS score seemed to be useful in predicting long-term T2D remission after bariatric surgery.

A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial study protocol.

INTRODUCTION: Imaging-confirmed uncomplicated acute appendicitis can be effectively and safely treated with antibiotics in most adults and children. Symptomatic treatment may have similar efficacy and safety. METHODS AND ANALYSIS: The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. INCLUSION CRITERIA: 1) age ≥ 7 and < 16 years, 2) imaging-confirmed uncomplicated acute appendicitis and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency laparoscopic appendectomy or symptomatic treatment. To ensure patient safety, symptomatically treated patients are hospitalized for at least 24 h receiving standard practice intravenous fluids and analgesics according to standard clinical practice. Primary outcome is 30-day treatment success defined by the absence of any treatment failure criteria. In appendectomy, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In symptomatic treatment, treatment failure is defined as 1) inability for hospital discharge without appendectomy within 48 h after randomization with a finding of histopathologically inflamed appendix, 2) appendectomy during the initial hospital stay due to clinical progression of appendicitis with complicated acute appendicitis both histopathologically and surgically, 3) appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or 4) any complication of appendicitis requiring general anesthesia. Detailed predefined secondary outcomes will be analyzed. ETHICS AND DISSEMINATION: Study was approved by Ethics Committee of Helsinki University Hospital (ID:HUS/1993/2021), conducted in compliance with the declaration of Helsinki with results disseminated in peer-reviewed scientific journals. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05289713).

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial.

Importance: Long-term results from randomized clinical trials comparing laparoscopic sleeve gastrectomy (LSG) with laparoscopic Roux-en-Y-gastric bypass (LRYGB) are limited. Objective: To compare long-term outcomes of weight loss and remission of obesity-related comorbidities and the prevalence of gastroesophageal reflux symptoms (GERD), endoscopic esophagitis, and Barrett esophagus (BE) after LSG and LRYGB at 10 years. Design, Setting, and Participants: This 10-year observational follow-up evaluated patients in the Sleeve vs Bypass (SLEEVEPASS) multicenter equivalence randomized clinical trial comparing LSG and LRYGB in the treatment of severe obesity in which 240 patients aged 18 to 60 years with median body mass index of 44.6 were randomized to LSG (n = 121) or LRYGB (n = 119). The initial trial was conducted from April 2008 to June 2010 in Finland, with last follow-up on January 27, 2021. Interventions: LSG or LRYGB. Main Outcomes and Measures: The primary end point was 5-year percentage excess weight loss (%EWL). This current analysis focused on 10-year outcomes with special reference to reflux and BE. Results: At 10 years, of 240 randomized patients (121 randomized to LSG and 119 to LRYGB; 167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline BMI, 45.9 [6.0]), 2 never underwent surgery and there were 10 unrelated deaths; 193 of the remaining 228 patients (85%) completed follow-up on weight loss and comorbidities, and 176 of 228 (77%) underwent gastroscopy. Median (range) %EWL was 43.5% (2.1%-109.2%) after LSG and 50.7% (1.7%-111.7%) after LRYGB. Mean estimate %EWL was not equivalent between the procedures; %EWL was 8.4 (95% CI, 3.1-13.6) higher in LRYGB. After LSG and LRYGB, there was no statistically significant difference in type 2 diabetes remission (26% and 33%, respectively; P = .63), dyslipidemia (19% and 35%, respectively; P = .23), or obstructive sleep apnea (16% and 31%, respectively; P = .30). Hypertension remission was superior after LRYGB (8% vs 24%; P = .04). Esophagitis was more prevalent after LSG (31% vs 7%; P < .001) with no statistically significant difference in BE (4% vs 4%; P = .29). The overall reoperation rate was 15.7% for LSG and 18.5% for LRYGB (P = .57). Conclusions and Relevance: At 10 years, %EWL was greater after LRYGB and the procedures were not equivalent for weight loss, but both LSG and LRYGB resulted in good and sustainable weight loss. Esophagitis was more prevalent after LSG, but the cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT00793143.

Antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis (APPAC III): randomized double-blind superiority trial.

BACKGROUND: Non-operative management of uncomplicated acute appendicitis is an option, but omission of antibiotics from the regimen has not been tested. METHODS: A double-blind, placebo-controlled, superiority RCT in adults with CT-confirmed uncomplicated acute appendicitis was designed to compare placebo with antibiotics (intravenous ertapenem followed by oral levofloxacin and metronidazole). The primary endpoint was treatment success (resolution resulting in discharge without appendicectomy within 10 days); secondary outcomes included pain scores, complications, hospital stay, and return to work. RESULTS: From May 2017 to September 2020, 72 patients with a mean(s.d.) age of 37.5 (11.1) years were recruited at five hospitals. Six were excluded after randomization (5 early consent withdrawals, 1 randomization protocol violation), 35 were assigned to receive antibiotics, and 31 to receive placebo. Enrolment challenges (including hospital pharmacy resources in an acute-care surgery setting) meant that only the lowest sample size of three predefined scenarios was achieved. The 10-day treatment success rate was 87 (95 per cent c.i. 75 to 99) per cent for placebo and 97 (92 to 100) per cent for antibiotics. This clinical difference of 10 (90 per cent c.i. -0.9 to 21) per cent was not statistically different for the primary outcome (1-sided P = 0.142), and secondary outcomes were similar. CONCLUSION: The lack of antibiotic superiority statistically suggests that a non-inferiority trial against placebo is warranted in adults with CT-confirmed mild appendicitis. Registration number: EudraCT 2015-003634-26 (https://eudract.ema.europa.eu/eudract-web/index.faces), NCT03234296 (http://www.clinicaltrials.gov).

Appendicitis was the most common reason for emergency surgery, but we now know that mild and severe acute appendicitis are two different diseases. Severe appendicitis still necessitates removal of the appendix but antibiotics alone are an option for mild disease. This small study found that most cases of mild appendicitis to resolve even without antibiotics. Larger studies (more patients) would be needed to show that omitting antibiotics is safe and no worse than antibiotic therapy for milder acute appendicitis.

Maternal risk factors for congenital limb deficiencies: A population-based case-control study.

BACKGROUND: Risk factors for congenital limb deficiencies are poorly understood. OBJECTIVE: To investigate risk factors for congenital limb deficiencies. METHODS: We conducted a nationwide population-based case-control (1:5) study in Finland, using national registers on congenital anomalies, births, and induced abortions, cross-linked with data on maternal prescription medicine use obtained from the registers on Reimbursed Drug Purchases and Medical Special Reimbursements. Five hundred and four children with limb deficiencies (241 isolated, 181 syndromic, and 82 other associated anomalies) were identified, and 2,520 controls were matched to cases on residence and year of pregnancy. Non-syndromic cases (n = 323) were subdivided into longitudinal (n = 120), transverse (n = 123), intercalary (n = 24), mixed (n = 18), and unknown (n = 38) deficiencies. RESULTS: Pregestational diabetes was associated with all limb deficiencies (adjusted odds ratio [OR] 12.71, 95% confidence interval [CI] 2.37, 68.25) and with isolated (OR 11.42, 95% CI 2.00, 64.60) deficiencies. Primiparity was associated with increased risk of congenital limb deficiencies among all cases (OR 1.49, 95% CI 1.15, 1.93), isolated cases (OR 1.46, 95% CI 1.09, 1.96), and among cases with longitudinal (OR 1.90, 95% CI 1.24, 2.90) and transverse deficiencies (OR 1.75, 95% CI 1.13, 2.70). Young maternal age (<25 years) was associated with all congenital limb deficiencies (OR 1.40, 95% CI 1.02, 1.90) and transverse deficiencies (OR 1.76, 95% CI 1.05, 2.96). Advanced maternal age (≥35 years) was associated with syndromic (OR 1.82, 95% CI 1.19, 2.78) and transverse deficiencies (OR 1.94, 95% CI 1.06, 3.57). Maternal antiepileptic medication was associated with all (OR 5.77, 95% CI 1.75, 19.04) and with isolated cases (OR 3.83, 95% CI 1.02, 14.34). CONCLUSIONS: It is important that pregnant women taking medications, especially antiepileptics, or women with pregestational diabetes are carefully monitored with regard to the occurrence and risk of limb deficiencies in the fetus.

Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis: The APPAC II Randomized Clinical Trial.

Importance: Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known. Objective: To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis. Design, Setting, and Participants: The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019. Interventions: Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days. Main Outcomes and Measures: The primary end point was treatment success (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference. Results: Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin. Conclusion and Relevance: Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.

Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial.

BACKGROUND: Lyme neuroborreliosis (LNB) is often treated with intravenous ceftriaxone even if doxycycline is suggested to be noninferior to ceftriaxone. We evaluated the efficacy of oral doxycycline in comparison to ceftriaxone in the treatment of LNB. METHODS: Patients with neurological symptoms suggestive of LNB without other obvious reasons were recruited. The inclusion criteria were (1) production of Borrelia burgdorferi-specific antibodies in cerebrospinal fluid (CSF) or serum; (2) B. burgdorferi DNA in the CSF; or (3) an erythema migrans during the past 3 months. Participants were randomized in a 1:1 ratio to receive either oral doxycycline 100 mg twice daily for 4 weeks, or intravenous ceftriaxone 2 g daily for 3 weeks. The participants described their subjective condition with a visual analogue scale (VAS) from 0 to 10 (0 = normal; 10 = worst) before the treatment, and 4 and 12 months after the treatment. The primary outcome was the change in the VAS score at 12 months. RESULTS: Between 14 September 2012 and 28 December 2017, 210 adults with suspected LNB were assigned to receive doxycycline (n = 104) or ceftriaxone (n = 106). The per-protocol analysis comprised 82 patients with doxycycline and 84 patients with ceftriaxone. The mean change in the VAS score was -3.9 in the doxycycline group and -3.8 in the ceftriaxone group (mean difference, 0.17 [95% confidence interval, -.59 to .92], which is within the prespecified equivalence margins of -1 to 1 units). Participants in both groups improved equally. CONCLUSIONS: Oral doxycycline is equally effective as intravenous ceftriaxone in the treatment of LNB. CLINICAL TRIALS REGISTRATION: NCT01635530 and EudraCT 2012-000313-37.

The value of combined positron emission tomography/magnetic resonance imaging to diagnose inflammatory bowel disease: a prospective study.

BACKGROUND: The clinical utility of positron emission tomography/magnetic resonance imaging (PET/MRI) in comparison to standard work-up with patients with known or suspected inflammatory bowel disease (IBD) is unknown. PURPOSE: To evaluate the value of 18F-fluorodeoxyglucose (18F-FDG) PET/MRI in the diagnostics of IBD and further compare the data obtained using PET/MRI to histological findings. MATERIALS AND METHODS: Ten patients with relapse in IBD or with symptoms of suspected IBD were recruited either from a gastroenterology outpatient clinic or from a hospital ward. Intestinal inflammation was assessed with histology and 18F-FDG PET/MRI. Maximum standard uptake values (SUVmax) were calculated in six regions of the intestine (small bowel, ascending, transverse, descending and sigmoid colon, and rectum) and compared to histological analysis of inflammation activity. RESULTS: The study showed that both the inflammation activity (P = 0.008) and the region of the biopsy in the intestine (P = 0.015) had a significant effect on SUV. SUVs obtained from severe inflammation activity emerged significantly from the background (P = 0.006). In addition, the SUVs obtained from moderate inflammation raised from background, but the difference was not statistically significant (P = 0.083), while SUVs of mild inflammation were at the same level with SUVs of normal bowel wall (P = 0.988). CONCLUSION: 18F-FDG PET/MRI is a promising method of detecting especially severe inflammatory bowel lesions. More data are required to define its sensitivity and specificity.

18F-FDG positron emission tomography/computed tomography of cardiac implantable electronic device infections.

BACKGROUND: The diagnosis of cardiac implantable electronic device (CIED) infection is challenging because of its variable presentations. We studied the value of 2-[18F]fluoro-2-deoxy-D-glucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) in the detection of CIED infection. METHODS AND RESULTS: Thirty patients with suspected CIED infection underwent 18F-FDG-PET/CT. The control group was ten patients with asymptomatic CIED who underwent cancer-related 18F-FDG-PET/CT. 18F-FDG-PET/CT was evaluated visually, semiquantitatively as maximum standardized uptake value (SUVmax) and target-to-background ratio (TBR). Final diagnosis of CIED infection was based on clinical and bacteriological data. 18F-FDG-PET/CT was visually positive in all 9 patients with recent (≤ 8 weeks) implantation of CIED, but only 4 had confirmed CIED infection. 18F-FDG-PET/CT was true positive in 9 out of 21 cases with remote implantation of CIED and false positive in 3 (14.3%) cases. 18F-FDG-PET/CT was also false positive in 3 (30%) cases of control group. The SUVmax of the pocket area was significantly higher in patients with CIED infection than in the control group (4.8 ± 2.4 vs 2.0 ± .8, P < .001). By using the cut-off value of TBR ≥ 1.8, sensitivity of 18F-FDG-PET/CT for the diagnosis of CIED infection in patients with remote implantation was 90% and specificity 73%, PPV 75%, and NPV 89%. CONCLUSIONS: 18F-FDG-PET/CT is a sensitive but nonspecific method in the diagnosis of CIED infection.

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

Importance: Laparoscopic sleeve gastrectomy (LSG) is currently the predominant bariatric procedure, although long-term weight loss and quality-of-life (QoL) outcomes compared with laparoscopic Roux-en-Y gastric bypass (LRYGB) are lacking. Objective: To determine weight loss equivalence of LSG and LRYGB at 7 years in patients with morbid obesity, with special reference to long-term QoL. Design, Setting, and Participants: The SLEEVE vs byPASS (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted between March 10, 2008, and June 2, 2010, in Finland. The trial enrolled 240 patients with morbid obesity aged 18 to 60 years who were randomized to undergo either LSG or LRYGB with a 7-year follow-up (last follow-up, September 26, 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 4, 2018, to November 8, 2019. Interventions: Laparoscopic sleeve gastrectomy (n = 121) or LRYGB (n = 119). Main Outcomes and Measures: The primary end point was percentage excess weight loss (%EWL) at 5 years. Secondary predefined follow-up time points were 7, 10, 15, and 20 years, with included 7-year secondary end points of QoL and morbidity. Disease-specific QoL (DSQoL; Moorehead-Ardelt Quality of Life questionnaire [range of scores, -3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at 1, 3, 5, and 7 years postoperatively concurrently with weight loss. Results: Of 240 patients (167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline body mass index, 45.9 [6.0]), 182 (75.8%) completed the 7-year follow-up. The mean %EWL was 47% (95% CI, 43%-50%) after LSG and 55% (95% CI, 52%-59%) after LRYGB (difference, 8.7 percentage units [95% CI, 3.5-13.9 percentage units]). The mean (SD) DSQoL total score at 7 years was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (P = .63), and the median HRQoL total score was 0.88 (interquartile range [IQR], 0.78-0.95) after LSG and 0.87 (IQR, 0.78-0.95) after LRYGB (P = .37). Greater weight loss was associated with better DSQoL (r = 0.26; P < .001). At 7 years, mean (SD) DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; P < .001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; P = .07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (P = .42). Conclusions and Relevance: This study found that LSG and LRYGB were not equivalent in %EWL at 7 years. Laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than LSG, but the difference was not clinically relevant based on the prespecified equivalence margins. There was no difference in long-term QoL between the procedures. Bariatric surgery was associated with significant long-term DSQoL improvement, and greater weight loss was associated with better DSQoL. Trial Registration: ClinicalTrials.gov Identifier: NCT00793143.

Bankart versus Latarjet operation as a revision procedure after a failed arthroscopic Bankart repair.

BACKGROUND: An arthroscopic Bankart operation is the most common operative procedure to treat shoulder instability. In case of recurrence, both Bankart and Latarjet procedures are used as revision procedures. The purpose of this study was to compare the re-recurrence rate of instability and clinical results after arthroscopic revision Bankart and open revision Latarjet procedures following failed primary arthroscopic Bankart operations. METHODS: Consecutive patients operatively treated for shoulder instability at Turku University Hospital between 2002 and 2013 were analyzed. Patients who underwent a primary arthroscopic Bankart operation followed by a recurrence of instability and underwent a subsequent arthroscopic Bankart or open Latarjet revision operation with a minimum of 1 year of follow-up were called in for a follow-up evaluation. The re-recurrence of instability, Subjective Shoulder Value, and Western Ontario Shoulder Instability index were assessed. RESULTS: Of 69 patients, 48 (dropout rate, 30%) were available for follow-up. Recurrent instability symptoms occurred in 13 patients (43%) after the revision Bankart procedure and none after the revision Latarjet procedure. A statistically and clinically significant difference in the Western Ontario Shoulder Instability index was found between the patients after the revision Bankart and revision Latarjet operations (68% and 88%, respectively; P = .0166). CONCLUSIONS: The redislocation rate after an arthroscopic revision Bankart operation is high. Furthermore, patient-reported outcomes remain poor after a revision Bankart procedure compared with a revision Latarjet operation. We propose that in cases of recurring instability after a failed primary Bankart operation, an open Latarjet revision should be considered.

An observational study of technical and non-technical skills in advanced life support in the clinical setting.

OBJECTIVE: Technical skills (TS) and non-technical skills (NTS) are the primary elements ensuring patient safety during advanced life support (ALS) and effective crisis resource management (CRM). Both skills are needed to perform high-quality ALS, though they are traditionally practiced separately. The evidence of the association between NTS and TS in high-quality ALS performance is insufficient. Hence, we aimed to evaluate the association between the skills in real-life in-hospital ALS situations. METHODS: We video recorded real-life in-hospital ALS situations, analyzed TS and NTS demonstrated in them with an instrument measuring TS and NTS, and tested the linear association between NTS and TS using a linear mixed model. RESULTS: Among 50 real-life in-hospital ALS situations that we recorded, 20 had adequate data for analysis. NTS and TS total scores were associated with one another (slope 0.48, P < 0.001). All NTS subcategories were associated with the TS total score (slopes ranging from 0.29 to 0.39, P < 0.001). The NTS total score and TS subcategories (chest compression quality, ventilation quality, rhythm control and defibrillation quality) were associated with one another (slopes ranging from 0.37 to 0.56, P < 0.01). CONCLUSIONS: The resuscitation teams who demonstrated good NTS also performed the technical aspects of ALS better. The results suggest that NTS and TS have an association with one another in real-life in-hospital ALS situations. NTS performance had the most evident association with chest compression quality and rhythm control and defibrillation quality; these are considered the most crucial elements affecting outcomes of ALS. The findings of the study present novel information of what and why to emphasize in ALS training. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03017144.

The long-term learning effect related to the repeated use of the Finnish matrix sentence test and the Finnish digit triplet test.

Objectives: To assess are there learning-related improvements in the speech reception thresholds (SRTs) for the Finnish matrix sentence test (FMST) and the Finnish digit triplet test (FDTT) in repeated use over 12 months.Design: Test sessions were scheduled at 0, 1, 3, 6 and 12 months, and each session included five FMST measurements and four FDTT measurements. The within-session and inter-session improvements in SRTs were analysed with a linear mixed model.Study sample: Fifteen young normal-hearing participants.Results: Statistically significant mean improvements of 2.0 dB SNR and 1.2 dB SNR were detected for the FMST and the FDTT, respectively, over the 12-month follow-up period. For the FMST, majority of the improvement occurred during the first two test sessions. For the FDTT, statistically significant differences were detected only in comparison to the first test session and to the first test measurement of every session over the 12-month follow-up.Conclusions: Repeated use of the FMST led to significant learning-related improvements, but the improvements appeared to plateau by the third test session. For the FDTT, the overall improvements were smaller, but a significant within-session difference between the first and consecutive FDTT measurements persisted throughout the test sessions.

Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. Objective: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. Interventions: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. Design, Setting, and Participants: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. Main Outcomes and Measures: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. Results: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment. Conclusions and Relevance: In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy. Trial Registration: Clinicaltrials.gov Identifier: NCT01022567.

The Accuracy of Low-dose Computed Tomography Protocol in Patients With Suspected Acute Appendicitis: The OPTICAP Study.

OBJECTIVE: To compare diagnostic accuracy of contrast enhanced low-dose computed tomography (CT) accomplished in the OPTICAP trial phantom phase to standard CT in patients with suspected acute appendicitis. BACKGROUND: Increasing use of CT as the gold standard in diagnosing acute appendicitis has raised concerns regarding radiation exposure. Unenhanced low-dose CT protocols have shown similar diagnostic accuracy with standard CT for diagnosing appendicitis. To our knowledge, there are no other trials in which the same patient with suspected acute appendicitis underwent both standard and low-dose CT allowing interpatient comparison. METHODS: OPTICAP is an interpatient protocol sequence randomized noninferiority single-center trial performed at Turku University Hospital between November, 2015 and August, 2016. Sixty patients with suspected acute appendicitis and body mass index <30 kg/m were enrolled to undergo both standard and low-dose contrast enhanced CT scans, which were categorized as normal, uncomplicated or complicated appendicitis by 2 radiologists in blinded manner. All patients with CT confirmed appendicitis underwent appendectomy to obtain histopathology. RESULTS: The low-dose protocol was not inferior to standard protocol in terms of diagnostic accuracy; 79% [95% confidence interval (CI) 66%-89%) accurate diagnosis in low-dose and 80% (95% CI 67%-90%) in standard CT by primary radiologist. Accuracy to categorize appendicitis severity was 79% for both protocols. The mean radiation dose of low-dose CT was significantly lower compared with standard CT (3.33 and 4.44 mSv, respectively). CONCLUSION: Diagnostic accuracy of contrast enhanced low-dose CT was not inferior to standard CT in diagnosing acute appendicitis or distinguishing between uncomplicated and complicated acute appendicitis in patients with a high likelihood of acute appendicitis. Low-dose CT enabled significant radiation dose reduction.

Vein Harvest Wound Healing after Bypass Surgery for Critical Limb Ischemia.

BACKGROUND: Lower-limb revascularization surgery, especially when performed using the great saphenous vein, predisposes patients to major surgical trauma on initially ischemic tissue. Vein harvest wounds (VHWs) after infrainguinal revascularization heal slowly. This study's aim was to assess the factors associated with VHW healing after infrainquinal bypass surgery for critical limb ischemia (CLI). METHODS: A retrospective patient record study was conducted. All patients with CLI who underwent infrainguinal bypass surgery with autologous vein graft between January 1, 2015, and December 31, 2017, in the Turku University Hospital, were included. Follow-up data were collected until February 28, 2018. The following data was collected from the patient files; risk factors, ankle-brachial indices (ABIs), systolic toe pressures (STPs), the presence of an ischemic ulcer, VHW dehiscence, and the time when the VHW was completely healed. Procedures with outflow vessels at either popliteal or tibial artery were analyzed separately. Descriptive and univariate statistical analyses were performed. RESULTS: Altogether, 195 patients were operated on for CLI, of whom 133 (68.2%) patients had ischemic ulcers. The mean follow-up time was 535.0 days (range 3.0-1143.0 days). The mean ABI improvement was 0.49 (P = 0.00), and STP improvement, 39.9 mm Hg (P = 0.00). The median time taken when VHW was healed was 48.0 days (95% confidence interval [CI], 39.4-56.6) in patients without ischemic ulcers and 82.0 days (95% CI, 59.7-104.3) in patients with ischemic ulcers, P = 0.03. VHW in patients who underwent popliteal artery bypass (62 days, 95% CI, 12.9-93.0) healed faster than VHW in those who underwent tibial artery bypass (132 days, 95% CI, 48.0-93.0), P = 0.02. Risk factors and the preoperative or postoperative ABIs or STPs had no effect on VHW healing time. CONCLUSIONS: VHW healing was remarkably slower after revascularization surgery in patients with an ischemic foot ulcer than in those without ischemic ulcers.

Midlife Insulin Resistance as a Predictor for Late-Life Cognitive Function and Cerebrovascular Lesions.

BACKGROUND: Type 2 diabetes (T2DM) increases the risk for Alzheimer's disease (AD) but not for AD neuropathology. The association between T2DM and AD is assumed to be mediated through vascular mechanisms. However, insulin resistance (IR), the hallmark of T2DM, has been shown to associate with AD neuropathology and cognitive decline. OBJECTIVE: To evaluate if midlife IR predicts late-life cognitive performance and cerebrovascular lesions (white matter hyperintensities and total vascular burden), and whether cerebrovascular lesions and brain amyloid load are associated with cognitive functioning. METHODS: This exposure-to-control follow-up study examined 60 volunteers without dementia (mean age 70.9 years) with neurocognitive testing, brain 3T-MRI and amyloid-PET imaging. The volunteers were recruited from the Finnish Health 2000 survey (n = 6062) to attend follow-up examinations in 2014-2016 according to their insulin sensitivity in 2000 and their APOE genotype. The exposure group (n = 30) had IR in 2000 and the 30 controls had normal insulin sensitivity. There were 15 APOEɛ4 carriers per group. Statistical analyses were performed with multivariable linear models. RESULTS: At follow-up the IR+group performed worse on executive functions (p = 0.02) and processing speed (p = 0.007) than the IR- group. The groups did not differ in cerebrovascular lesions. No associations were found between cerebrovascular lesions and neurocognitive test scores. Brain amyloid deposition associated with slower processing speed. CONCLUSION: Midlife IR predicted poorer executive functions and slower processing speed, but not cerebrovascular lesions. Brain amyloid deposition was associated with slower processing speed. The association between midlife IR and late-life cognition might not be mediated through cerebrovascular lesions measured here.