bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome
Authors: Caiazzo Robert , Branche Julien , Raverdy Violeta , Czernichow Sébastien , Carette Claire , Robert Maud , Disse Emmanuel , Barthet Marc , Cariou Bertrand , Msika Simon , Behal Helene , Denies Fanette , Dervaux Benoit , Duhamel Alain , Verkindt Helene , Pattou François 
Published: September 2020

Objective:
The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).

Summary Background Data:
DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.

Methods:
We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed.

Results:
A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) −3.1 kg/m2 (−4.4 to −1.9) kg/m2, P < 0.001] and HbA1c change [mean adjusted difference −0.5% (95% CI −0.9 to −0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.

Conclusions:
The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.
Management and In-hospital Mortality of 2203 Patients With a Traumatic Intimal Tear of the Thoracic Aorta
Authors: Jacob-Brassard Jean , Al-Omran Mohammed , Nathens Avery B. , Forbes Thomas L. , de Mestral Charles 
Published: September 2020

Objective:
Our goal was to describe contemporary management and inhospital mortality associated with blunt thoracic aortic intimal tears (IT) within the American College of Surgeons Trauma Quality Improvement Program.

Summary Background Data:
The evidence basis for nonoperative expectant management of traumatic iT of the thoracic aorta remains weak.

Methods:
All adult patients with a thoracic aortic IT following blunt trauma were captured from Level I and II North American Centers enrolled in Trauma Quality Improvement Program from 2010 to 2017. For each patient, we extracted demographics, injury characteristics, the timing and approach of thoracic aortic repair and in-hospital mortality. Mortality attributable to IT was calculated by comparing IT patients to a propensity-score matched control cohort of severely injured blunt trauma patients without aortic injury.

Results:
There were 2203 IT patients across 315 facilities. Injury most often resulted from motor vehicle collision (75%). A total of 758 patients (34%) underwent operative management, with 93% (N = 708) of repairs performed via an endovascular approach. Median time to surgery was 11 hours (IQR 4– 40). The frequency of operative management was higher in patients without traumatic brain injury (TBI) (35%, N = 674) compared to those with TBI (29%, N = 84) (P = 0.024). Compared to severely injured blunt trauma patients without aortic injury, ITwas not associated with additional in-hospital mortality (10.7% for IT vs 11.7% for no IT, absolute risk difference: –1.0%, 95% CI: –2.9% to 0.8%).

Conclusions:
The majority of blunt thoracic IT are managed nonoperatively and IT does not confer additional in-hospital mortality risk. Future studies should focus on the risk of injury progression.
Percutaneous and Open Tracheostomy in Patients with COVID-19
Authors: Long Sallie M. , Chern Alexander , Feit Noah Z. , Chung Sei , Ramaswamy Apoorva T. , Li Carol , Cooley Victoria , Hill Shanna , Rajwani Kapil , Villena-Vargas Jonathan , Schenck Edward , Stiles Brendon , Tassler Andrew B. 
Published: September 2020

Objective:
The aim of this study was to report the safety, efficacy, and early results of tracheostomy in patients with COVID-19 and determine whether differences exist between percutaneous and open methods.

Summary Background Data:
Prolonged respiratory failure is common in symptomatic patients with COVID-19, the disease process caused by infection with the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Tracheostomy, although posing potential risk to the operative team and other healthcare workers, may be beneficial for safe weaning of sedation and ventilator support. However, short- and long-term outcomes remain largely unknown.

Methods:
A prospectively collected database of patients with COVID-19 undergoing tracheostomy at a major medical center in New York City between April 4 and April 30, 2020 was reviewed. The primary endpoint was need for continued mechanical ventilation. Secondary outcomes included complication rates, sedation weaning, and need for intensive care unit (ICU) level of care. Patient characteristics, perioperative conditions, and outcomes between percutaneous and open groups were analyzed.

Results:
During the study period, 67 consecutive patients underwent tracheostomy, including 48 males and 19 females with a median age of 66 years [interquartile range (IQR) 52–72]. Two surgeons alternated techniques, with 35 tracheostomies performed percutaneously and 32 via an open approach. The median time from intubation to tracheostomy was 23 days (IQR 20–26). At a median follow-up of 26 days, 52 patients (78%) no longer required mechanical ventilation and 58 patients (87%) were off continuous sedation. Five patients (7.5%) died of systemic causes. There were 11 total complications (16%) in 10 patients, most of which involved minor bleeding. There were no significant differences in outcomes between percutaneous and open methods.

Conclusions:
Tracheostomy under apneic conditions by either percutaneous or open technique can be safely performed in patients with respiratory failure due to COVID-19. Tracheostomy facilitated weaning from continuous intravenous sedation and mechanical ventilation. Continued follow-up of these patients to ascertain long-term outcome data is ongoing.
Short-term Outcomes of “Difficult” Laparoscopic Liver Resection at Specialized Centers
Authors: Ibuki Sho , Hibi Taizo , Tanabe Minoru , Geller David A. , Cherqui Daniel , Wakabayashi Go 
Published: September 2020

Objective:
To define the current status of “difficult” LLR, a global database was created and investigated.

Background:
In the Second International Consensus Conference in 2014, minor LLR was considered as a standard practice and major LLR remained an innovative procedure. Since then, no updates on worldwide trends have been available.

Methods:
A questionnaire on all consecutive patients who underwent difficult LLR (major hepatectomy, posterosuperior segmentectomy, sectionec-tomy, living donor hepatectomy, tumor size ≥10 cm, Child-Pugh grade ≥B, combined with biliary reconstruction, and Iwate criteria difficulty score ≥7) in 2014–2018 was distributed via email to 65 high-volume LLR centers worldwide. individual data on patient and tumor demographics, surgical information, and short-term outcomes were obtained to create a large-scale international registry for analyses.

Results:
Overall, 58 centers in 19 countries performed 4478 difficult LLR (median, 58.5; range, 5–418) during the study period. Hepatocellular carcinoma accounted for ≥ 40% of all indications. Half of the patients underwent major hepatectomy, followed by sectionectomy, posterosuperior segmentectomy, and living donor hepatectomy. in the vast majority of procedures, Clavien-Dindo grade ≥IIIa complication rates of ≈10% and 90-day mortality rates of ≈1% were achieved. Left or right trisectionectomy had the worst Clavien-Dindo grade ≥IIIa complication rate of ≥10% and 90-day mortality rate of 5%–10%. No significant correlation was observed between center volume and short-term outcomes.

Conclusions:
Total 4478 patients underwent difficult LLR worldwide in 2014–2018. Most procedures are safe and feasible when conducted in specialized centers.
Residential Racial Segregation and Disparities in Breast Cancer Presentation, Treatment, and Survival
Authors: Poulson Michael R. , Beaulieu-Jones Brendin R. , Kenzik Kelly M. , Dechert Tracey A. , Ko Naomi Y. , Sachs Teviah E. , Cassidy Michael R. 
Published: September 2020

Objective:
To understand the role of racial residential segregation on Black-White disparities in breast cancer presentation, treatment, and outcomes.

Summary of Background Data:
Racial disparities in breast cancer treatment and outcomes are well documented. Black individuals present at advanced stage, are less likely to receive appropriate surgical and adjuvant treatment, and have lower overall and stage-specific survival relative to White individuals.

Methods:
Using data from the Surveillance, Epidemiology, and End Results program, we performed a retrospective cohort study of Black and White patients diagnosed with invasive breast cancer from 2005 to 2015 within the 100 most populous participating counties. The racial index of dissimilarity was used as a validated measure of residential segregation. Multivariable regression was performed, predicting advanced stage at diagnosis (stage III/IV), surgery for localized disease (stage I/II), and overall stage-specific survival.

Results:
After adjusting for age at diagnosis, estrogen/progesterone receptor status, and region, Black patients have a 49% greater risk (relative risk [RR] 1.49 95% confidence interval [CI] 1.27, 1.74) of presenting at advanced stage with increasing segregation, while there was no observed difference in Whites (RR 1.04, 95% CI 0.93, 1.16). Black patients were 3% less likely to undergo surgical resection for localized disease (RR 0.97, 95% CI 0.95, 0.99) with increasing segregation, while Whites saw no significant difference. Black patients had a 29% increased hazard of death (RR 1.29, 95% CI 1.04, 1.60) with increasing segregation; there was no significant difference among White patients.

Conclusions:
Our data suggest that residential racial segregation has a significant association with Black-White racial disparities in breast cancer. These findings illustrate the importance of addressing structural racism and residential segregation in efforts to reduce Black-White breast cancer disparities.
Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy
Authors: de Jong Judith J. , Latenstein Carmen S. S. , Boerma Djamila , Hazebroek Eric J. , Hirsch David , Heikens Joost T. , Konsten Joop , Polat Fatih , Lantinga Marten A. , van Laarhoven Cornelis J. H. M. , Drenth Joost P. H. , de Reuver Philip R. 
Published: September 2020

Objective:
To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state.

Summary Background Data:
More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome.

Methods:
We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6 months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4.

Results:
We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001.

Conclusions:
One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process.

Trial Registration:
The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.
Associations Between Physical Activity and Changes in Weight Across 7 Years After Roux-en-Y Gastric Bypass Surgery
Authors: King Wendy C. , Hinerman Amanda S. , White Gretchen E. , Courcoulas Anita P. , Saad Mohammed A. Bu , Belle Steven H. 
Published: September 2020

Objective:
To examine associations of objectively-measured physical activity (PA) with changes in weight after roux-en-Y gastric bypass (RYGB) over 7 years.

Background:
The contribution of free-living PA to surgery-induced weight loss and subsequent weight regain is not well understood.

Methods:
Participants of a multi-center prospective cohort study of bariatric surgery were followed annually ≥7 years. Of 807 participants who underwent RYGB and were given an activity monitor, 649 (80%) had sufficient data for this report (78% female; median age 47 years; median body mass index 46 kg/m2). Mean daily steps, hours/day in SB and minutes/week in moderate-to-vigorous physical activity (MVPA) were determined at each assessment. Mixed models tested associations between PA measures and weight outcomes, controlling for sociodemographics, health status, and eating behaviors.

Results:
Across follow-up, mean pre to postsurgery changes in PA were small, and mean postsurgery PA level was below PA recommendations for health (eg, 101 MVPA min/week 7 years postsurgery versus the ≥150 MVPA min/week recommendation). There was a dose-response association between more steps, less SB and more MVPA with greater weight loss. Steps and SB, but not MVPA, were also associated with weight regain. For example, participants in the highest versus lowest steps quartile lost 2.9% (95% confidence interval, 1.8–4.1) more of their presurgery weight and regained 5.4% (95% confidence interval, 2.4–8.3) less of their maximum weight lost across follow-up.

Conclusions:
Despite only small increases in objectively-measured PA level after RYGB, PA level was independently associated with weight outcomes of bariatric surgery throughout 7 years of follow-up.

Reprints:
Reprints will not be available from the authors.
Outcomes for Physiologic Microsurgical Treatment of Secondary Lymphedema Involving the Extremity
Authors: Beederman Maureen , Garza Rebecca M. , Agarwal Shailesh , Chang David W. 
Published: September 2020

Objective:
The aim of this study was to examine the long-term impact of physiologic surgical options, including VLNT and LVB, on patients with secondary lymphedema of the upper or lower extremity (UEL/LEL).

Summary Background Data:
VLNT and LVB have become increasingly popular in the treatment of lymphedema. However, there is a paucity of long-term data on patient outcomes after use of these techniques to treat lymphedema.

Methods:
An analysis of prospectively collected data on all patients who underwent physiologic surgical treatment of secondary lymphedema over a 5.5-year period was performed. Patient demographics, surgical details, subjective reported improvements, LLIS scores, and postoperative limb volume calculations were analyzed.

Results:
Two hundred seventy-four patients with secondary lymphedema (197 upper, 77 lower) were included in the study. More than 87% of UEL patients and 60% of LEL patients had reduction in excess limb volume postoperatively. At 3 months postoperatively, patients with UEL had a 31.1% reduction in volume difference between limbs, 33.9% at 6 months, 25.7% at 12 months, 47.4% at 24 months and 47.7% at 4 years. The reduction in limb volume difference followed a similar pattern but was overall lower for LEL patients. Greater than 86% of UEL and 75% of LEL patients also had improvement in LLIS scores postoperatively. Fifty-nine complications occurred (12.9%); flap survival was >99%.

Conclusions:
Patients with secondary UEL/LEL who undergo VLNT/LVB demonstrate improved functional status and reduced affected limb volumes postoperatively. Patients with UEL seem to have a more substantial reduction in limb volume differential compared to LEL patients.
Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation
Authors: Osho Asishana A. , Moonsamy Philicia , Ethridge Breanna R. , Leya Gregory A. , D’Alessandro David A. , Jassar Arminder S. , Villavicencio Mauricio A. , Melnitchouk Serguei I. , Tolis George , Langer Nathaniel B. , Funamoto Masaki , Li Selena S. , Colon Katia M. , Mohan Navyatha , Locascio Joseph J. , Lubitz Steven A. , Akeju Oluwaseun , Sundt Thoralf M. 
Published: September 2020

Objective:This manuscript describes the rationale and design of a randomized, controlled trial comparing outcomes with Warfarin vs Novel Oral Anticoagulant (NOAC) therapy in patients with new onset atrial fibrillation after cardiac surgery.Background:New onset atrial fibrillation commonly occurs after cardiac surgery and is associated with increased rates of stroke and mortality. in nonsurgical patients with atrial fibrillation, NOACs have been shown to confer equivalent benefits for stroke prevention with less bleeding risk and less tedious monitoring requirements compared with Warfarin. However, NOAC use has yet to be adopted widely in cardiac surgery patients.Methods:The NEW-AF study has been designed as a pragmatic, prospective, randomized controlled trial that will compare financial, convenience and safety outcomes for patients with new onset atrial fibrillation after cardiac surgery that are treated with NOACs versus WarfarinResults:Study results may contribute to optimizing the options for stroke prophylaxis in cardiac surgery patients and catalyze more widespread application of NOAC therapy in this patient population.Conclusions:The study is ongoing and actively enrolling at the time of the publication. The trial is registered with clinicaltrials.gov under registration number NCT03702582.
Assessment of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
Authors: Lu Jun , Zheng Chao-Hui , Xu Bin-Bin , Xie Jian-Wei , Wang Jia-Bin , Lin Jian-Xian , Chen Qi-Yue , Cao Long-Long , Lin Mi , Tu Ru-Hong , Huang Ze-Ning , Lin Ju-Li , Zheng Hua-Long , Huang Chang-Ming , Li Ping 
Published: September 2020

Objective:
To evaluate the short-term outcomes of patients with GC who received RDG or LDG.

Summary Background Data:
Despite the increasing use of RDG in patients with GC, its safety and efficacy compared to those of LDG have not been elucidated in a randomized controlled trial.

Methods:
Three hundred patients with cT1-4a and N0/+ between September 2017 and January 2020 were enrolled in this randomized controlled trial at a high-volume hospital in China. The short-term outcomes were compared between the groups.

Results:
The modified intention-to-treat analysis included data from 283 patients (RDG group: n = 141) and (LDG group: n = 142). Patients in the RDG group exhibited faster postoperative recovery, milder inflammatory responses, and reduced postoperative morbidity (9.2% vs 17.6%, respectively, P = 0.039). Higher extraperigastric lymph nodes (LNs) were retrieved in the RDG group (17.6 ± 5.8 vs 15.8 ± 6.6, P = 0.018) with lower noncompliance rate (7.7% vs 16.9%, respectively, P = 0.006). Additionally, patients in the RDG group were more likely to initiate adjuvant chemotherapy earlier [median (interquartile range) postoperative days: 28 (24–32) vs 32 (26–42), P = 0.003]. Although total hospital costs were higher in the robotic group than in the laparoscopic group, the direct cost was lower for RDG than for LDG (all P < 0.001).

Conclusions:
RDG is associated with a lower morbidity rate, faster recovery, milder inflammatory responses, and improved lymphadenectomy. Additionally, faster postoperative recovery in the RDG group enables early initiation of adjuvant chemotherapy. Our results provide evidence for the application of RDG in patients with GC.
Compromised AMPK-PGCIα Axis Exacerbated Steatotic Graft Injury by Dysregulating Mitochondrial Homeostasis in Living Donor Liver Transplantation
Authors: Liu Jiang , Pang Li , Ng Kevin T.P. , Chiu T.L. Shirley , Liu Hui , Liu Xiaobing , Xu Aimin , Lo Chung-Mau , Man Kwan 
Published: September 2020

Objective:
To investigate the association of graft steatosis with long-term outcome, and to elucidate the mechanism of steatotic graft injury in adult living donor liver transplantation.

Summary of Background Data:
The utilization of steatotic graft expands the donor pool for living donor liver transplantation (LDLT). However, it remains controversial due to its high morbidity and mortality. Elucidating the mechanism of steatotic graft injury is crucial to develop therapeutic strategies targeting at graft injury and to further expand the donor pool.

Methods:
Five hundred thirty patients receiving LDLT were prospectively included for risk factor analysis and outcome comparison. Rat orthotopic liver transplantation, in vitro functional experiments and mouse hepatic ischemia/ reperfusion models were established to explore the mechanisms of steatotic graft injury.

Results:
We identified that graft with >10% steatosis was an independent risk factor for long-term graft loss after LDLT (hazard ratio 2.652, P = 0.001), and was associated with shorter cancer recurrence-free survival and acute phase liver injury. Steatotic graft displayed distinct mitochondrial dysfunction, including membrane, calcium, and energy homeostasis dysregulation. Specifically, the mitochondrial biogenesis was remarkably downregulated in steatotic graft. Inhibition of AMPK-PGC1α axis impaired mitochondrial biogenesis and was lethal to fatty hepatocyte in vitro, whereas reactivation of AMPK promoted PGC1α-mediated mitochondrial biogenesis and attenuated liver injury via restoring mitochondrial function in animal model. Conclusions: We provided a new mechanism that compromised AMPK-PGC1α axis exacerbated steatotic graft injury in LDLT by dysregulating mitochondrial homeostasis through impairment of biogenesis.