bluuebunny/crossref_metadata_2025 huggingface dataset:
The Effectiveness of Early Combined CO2 Ablative Fractional Laser and 595-nm Pulsed Dye Laser Treatment After Scar Revision
Authors: Song Woo Jin , Nam Seung Min , Park Eun Soo , Choi Chang Yong , Lee Sang Won
Published: September 2020

Scars are significant complications of wound healing and associated with negative physical, psychological, and cosmetic effects. Scar revision and laser treatment have been used over the past century to improve many different types of scars. Here, we evaluated the effectiveness of early combined carbon dioxide ablative fractional laser (AFL) and pulsed dye laser (PDL) treatment after scar revision. Fourteen patients who underwent scar revision were enrolled. All patients were treated with both a 10,600-nm AFL and a 595-nm PDL commencing 2 weeks after scar revision and continuing at 4-week intervals for a total of 4 treatments. Vancouver Scar Scale scores were evaluated before treatment and 5 months after the final treatment. All Vancouver Scar Scale scores improved significantly except that of scar height. We encountered no adverse complications (wound disruption, or hyper- or hypopigmentation) during follow-up. Early combined carbon dioxide AFL and PDL treatment after scar revision effectively and safely minimized scar formation.
Volleyball-related Adult Maxillofacial Trauma Injuries: A NEISS Database Study
Authors: Reich Jeremy S. , Cohn Jason E. , Othman Sammy , Shokri Tom , Ducic Yadranko , Sokoya Mofiyinfolu
Published: September 2020

Introduction:

Craniofacial trauma among athletes of various sports has been well detailed and described. Despite this research, there is a dearth of literature describing the nature of facial trauma secondary to volleyball, despite its global popularity.

Methods:

A cross-sectional analysis of volleyball-related facial trauma was conducted using the National Electronic Injury Surveillance System (NEISS) database from 2009 to 2018. Patient demographics (age, sex, and race), medical injury information (injury type and location), and disposition (observed and discharged, admitted, deceased) were collected and analyzed. χ
2 testing was performed to compare categorical variables.

Results:

A total of 235 volleyball-related facial traumas were recorded with an estimated 10,424 visits occurring nationally. The majority of injuries were among young adults aged 20 to 29 years (52.3%) and was evenly distributed for men and women. Lacerations were the most frequent injury type (37.9%), whereas the face was the most common site of injury (41.7%). The majority of fractures involved the nose (71.4%) and among individuals aged 20 through 49 (90.5%). Males had significantly more lacerations than females (75.3% vs 24.7%), whereas females had significantly more contusions/abrasions (64.5% vs 35.5%) and concussions (72.9% vs 27.1%).

Conclusions:

Volleyball-related craniofacial injuries can vary depending on patient demographics. This information can help with the development of safety and preventative measures for individuals participating in the sport.
Enhanced Recovery After Surgery Protocol for Primary Cleft Palate Repair: Improving Transition of Care
Authors: Moffitt Joseph K. , Cepeda Alfredo , Ekeoduru Rhashedah A. , Teichgraeber John F. , Nguyen Phuong D. , Greives Matthew R.
Published: September 2020

Background:

Enhanced recovery after surgery (ERAS) protocols have been adopted for many types of surgery. Postoperative pain following palatoplasty may cause feeding and swallowing difficulty. Our study evaluated the use of ERAS protocols to improve the management of pain following primary palatoplasty as well as in the transition of care from inpatient to outpatient.

Methods:

An Institutional Review Board approved retrospective analysis was performed for patients who previously underwent primary palatoplasty before ERAS implementation. Separately, an Institutional Review Board approved prospective trial of patients undergoing primary palatoplasty was performed and these patients were managed with ERAS protocols. Data were obtained for length of stay, pain scale scores, milligrams of morphine administered, and inpatient readmissions/emergency department visits. Outpatient medication logs were used to follow pain medicine usage, and a satisfaction survey was administered at the first postoperative visit.

Results:

Data were obtained retrospectively for 56 patients and prospectively for 57 patients who underwent primary palatoplasty. Patients in the ERAS protocol received significantly less milligrams of morphine on postoperative day 1 through day 4 than those patients in the usual care group P < 0.05. No significant difference was observed for length of stay, oral intake prior to discharge, or inpatient face, legs, activity, cry, consolability pain scale scores. Outpatient medication logs showed a continued decrease in narcotic usage at home with no spike post discharge day 1. Parents reported high satisfaction levels for inpatient pain management (4.66 ± 0.49) and even higher satisfaction levels for understanding (5.0 ± 0) and management of pain at home (4.92 ± 0.29). Return visits to the hospital for pain management following primary palatoplasty decreased from 7.1% (4) following the previous protocol to 0% with the new ERAS protocol (P = 0.057).

Conclusion:

The ERAS protocols provide improved inpatient pain management following primary palatoplasty as evidence by decreased total narcotic pain medication usage. The use of multimodality therapy and increased patient education regarding non-narcotic medications can improve the transition of care from inpatient to outpatient, without sacrificing patient/parent satisfaction. The results of this study merit future study into more restricted use of opioid pain medications with greater emphasis on the use of multimodal therapeutics as primary agents as opposed to adjuncts.
Advantages of Small Bone-Window Craniotomy Under Microscope Combined Postoperative Intracranial Pressure Monitoring in the Treatment of Hypertensive Intracerebral Hemorrhage
Authors: Men Donghai , Huang Zixiong , Yin Yanqing , Wu Weichuan , Li Wensheng , Liu Huanqiang , Xu Chengjie
Published: September 2020

Objective:

The aim of this study is to analyze the clinical effect of small bone-window craniotomy with microscope combined postoperative ICP monitoring, and further explore an appropriate treatment for HICH patients.

Methods:

One hundred fifty patients with HICH were selected according to inclusion and exclusion criteria and divided into 3 groups at random, 50 each group. Patients in 3 groups were treated with conventional craniotomy, small bone-window craniotomy and small bone-window craniotomy combined ICP monitoring respectively. The surgical efficiency, treatment effect and outcomes were recorded and analyzed.

Results:

The intraoperative blood loss and operation time of small window groups were significantly less than that of conventional group, and the hematoma clearance rate in small window groups were significantly higher than in conventional group (P < 0.05). Compared with conventional group, the hospital stays and mannitol dose used were less in small window groups and least in small window combined ICP monitoring group (P < 0.05). The complication rate in small window combined ICP monitoring group was 10%, which was significantly lower than in conventional group (26%, P < 0.05), while no significant difference was found between small window group (18%) compared with the other 2 groups respectively (P > 0.05). The difference of morality rate between 3 groups wasn’t significant (P > 0.05). Three treatment significantly increased the Barthel index score, and the improvement of small window combined ICP monitoring group was significantly higher than in other 2 groups respectively (P < 0.05), while the difference between this two groups wasn’t significant (P > 0.05).

Conclusion:

Small bone-window craniotomy is more efficient and convenient than conventional craniotomy in the treatment of HICH. In the meantime, small bone-window craniotomy simultaneous with ICP monitoring significantly improved clinical effect and treatment outcomes of HICH patients.
Concurrent High Condylectomy and Orthognathic Surgery for Treatment of Patients With Unilateral Condylar Hyperplasia
Authors: Maniskas Seija A. , Ly Catherine L. , Pourtaheri Navid , Parsaei Yassmin , Steinbacher Derek M.
Published: September 2020

Background:

Facial asymmetry from unilateral condylar hyperplasia (UCH) may be definitively treated in the presence of active disease (with high condylectomy and concurrent orthognathic surgery) or after waiting for disease inactivity (orthognathic surgery alone). There is currently no consensus on the standard of care. In this study, we sought to compare functional and esthetic outcomes, as well as treatment duration, between these 2 management options.

Methods:

Patients who underwent treatment for UCH were identified through retrospective review. Pre- and postoperative 3-dimensional (3D) images were obtained. Short- and long-term operative outcomes of those treated during the active (group 1) were compared to those treated in the inactive phase (group 2). Total treatment time, operative time, and length of hospital stay were evaluated. Facial asymmetry was also assessed by laypersons using a Likert scale.

Results:

Fifteen patients (mean 25.6 years, range 14–56) were included: 6 in group 1 and 9 in group 2. All surgical outcomes were statistically independent of procedure type. Treatment time was significantly longer in the group 2 (P = 0.03). Both groups demonstrated significant improvement in facial asymmetry scores postoperatively with no significant difference in pre- or postoperative asymmetry between groups (P = 0.64).

Conclusions:

In patients with active UCH, high condylectomy and orthognathic surgery is a procedure that restores facial symmetry and improves jaw function while halting mandibular growth. Good esthetic and functional outcomes, as well as reduced treatment time and disease burden, support the use of this treatment option for this population.
Open Reduction, Internal Fixation, or Maxillo-Mandibular Fixation for Isolated, Unilateral, Tooth-Bearing, Mandibular Body Fractures in Children
Authors: Lopez Joseph , Reategui Alvaro , Yesantharao Pooja S. , Yang Robin , Redett Richard J. , Manson Paul N. , Dorafshar Amir
Published: September 2020

Background:

Mandibular body fractures can cause severe and long-term morbidity in the pediatric population. Nonetheless, there is insufficient data on the treatment and management of this specific fracture type in children. This study aimed to investigate the etiology, treatment, and outcomes of pediatric mandibular body fractures by analyzing our institution's experience managing these uncommon injuries

Methods:

This was a 30-year retrospective, longitudinal cohort study of pediatric patients presenting to a single institution with isolated, unilateral, mandibular body fractures. Patient data was extracted from electronic medical records, while subgroup analysis was completed by dentition stage.

Results:

A total of 14 patients met inclusion criteria, of whom 8 (57.1%) had deciduous, 3 (21.4%) had mixed, and 3 (21.4%) had permanent dentition. Deciduous dentition patients with displaced, mobile or comminuted fractures underwent open reduction and internal fixation (ORIF), while those with nondisplaced and/or nonmobile fractures received soft diet or closed treatment with maxillomandibular fixation. For the mixed dentition cohort, all patients (100%) received closed treatment with maxillomandibular fixation. Among permanent dentition patients, most patients (66.6%) underwent ORIF regardless of fracture severity. The post-ORIF complication rate was 20% (dental maleruption).

Conclusions:

Isolated, unilateral mandible body fractures are relatively uncommon in the pediatric population, and management differs by dentition stage and injury pattern. While isolated body fractures had considerable associated morbidity, this fracture pattern did not result in major growth restrictions or malformations.
Can the Bone Density Estimated by CBCT Predict the Primary Stability of Dental Implants? A New Measurement Protocol
Authors: Al-Jamal Mustafa Faisal J. , Al-Jumaily Hassanien A.
Published: September 2020

Background:

The use of dental implants to restore edentulous parts of the jaws is a common and well-documented treatment method. Effective dental implant treatment is known to be affected by both the quality and the quantity of bone required for implant placement, bone quality is a critical factor to consider when predicting stability of implants. Thus, stability of the initial implant and the possibility of early loading could be predicated using cone-beam computed tomography (CBCT) scans and primary stability parameters before implant placement.

Objectives:

The aim of this study was to objectively assess bone density obtained by CBCT and the correlations with primary stability of dental implants using implant stability meter IST device.

Methods:

A total of 40 implants were placed in 16 patients (9 males and 7 females with a range of 22 to 61 years (mean age 40.44 ± 12.3 years). The bone densities of implant recipient sites were preoperatively recorded using CBCT. The maximum insertion torque value of each implant was measured by engine during implant placement and compared to the primary stability for every implant using implant stability meter device (IST).

Results:

A statistically significant correlation was found between bone density value from CBCT with the primary implant stability and insertion torque.

Conclusion:

Although the small samples size, the study shown bone density assessment using CBCT is an efficient method and significantly correlated with primary stability using implant stability meter device IST and insertion torque.
Management of Medially Displaced Sub-Condylar Mandibular Fractures in Pediatric Population Using Novel Atraumatic Approach
Authors: Aksoyler Dicle , Doğan Fatih , Bolletta Alberto , Sengenc Esma , Sönmez Taha , Yavan Mehmet Ali
Published: September 2020

The appropriate treatment of pediatric mandibular condyle fractures is subject to much debate and concern among surgeons, with improper treatment potentially resulting in a number of adverse outcomes. Such outcomes include the disruption of mandible growth, decreased posterior facial height, facial asymmetry, and temporomandibular joint ankylosis. Several surgical and nonsurgical approaches to these fractures have been described in the literature; however, each one carries its own risk of various complications. In this study, the authors illustrate a new atraumatic approach for mild to moderately displaced subcondylar fractures, with least possible complications and unexpected outcomes. In this study, 6 patients (2 female and 4 male) with unilateral medially displaced condylar base and neck fractures, angulated between 30 and 45 degrees, were treated using a novel intraoral approach. The follow-up period varied from 12 to 18 months. All patients achieved normal occlusion and had painless functioning of the temporomandibular joint with proper mouth opening (>35 mm) without any recurrence at long term follow up. This minimally invasive approach could eliminate the possibility of major complications and be considered a safe and feasible surgical technique for certain cases of pediatric mandibular condyle fracture.
Effect of Operative Timing and Bone Grafting on Postoperative Cephalometric Indices in Nonsyndromic Sagittal Synostosis
Authors: Varman Rahul M. , Van Spronsen Nicole , Nagy Laszlo , Demke Joshua
Published: September 2020

Surgical repair of sagittal suture craniosynostosis is highly variable, and optimal timing/use of bone grafts remains a subset of parameters that continue to be studied. We sought to compare cephalometric outcomes of early surgical intervention without bone grafting compared to later intervention with bone grafting. Patients undergoing primary surgical repair of nonsyndromic sagittal suture craniosynostosis between 2015 and 2019 were followed with preoperative measurements of cephalic index along with postoperative measurements at 6 months to 1 year, respectively. Nineteen patients undergoing cranial vault reconstruction were studied in 2 groups, namely those younger than 6 months who did not have bone grafting performed during primary repair (31.6%) and patients 6 months and older who underwent cranial vault reconstruction with bone grafting during primary repair (68.4%). Mean 6-month to 1-year postoperative cranial index was significantly increased in both groups (P < 0.001). The average cephalic index change for both groups (younger than 6 months without bone grafting, CI value change 9; 6 months and older with bone grafting; CI value change 6) was not significantly different with regards to 95% confidence interval (P = 0.30). Patients older than 6 months of age undergoing cranial vault reconstruction with bone grafting have similar cephalometric outcomes as their younger counterparts undergoing cranial vault remodeling without bone grafting. Bone grafting in the appropriate cohort may improve functional and esthetic outcomes without compromising primary surgical goals of improving cranial vault cephalometric indices.
Prevalence of Endoscopic Retrograde Cholangiopancreatography Complications and Amylase Sensitivity for Predicting Pancreatitis in ERCP Patients
Authors: Hormati Ahmad , Alemi Faezeh , Mohammadbeigi Abolfazl , Sarkeshikian Seyyed Saeed , Saeidi Mohammad
Published: September 2020

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure that is widely used for diagnosis and treatment of biliary and pancreatic diseases. With respect to its growing application, the present study aims to evaluate ERCP outcomes and complications. This cross-sectional study was performed using the data from 824 patients who underwent ERCP during 2014–2017 in Qom Shahid Beheshti hospital. Data were collected by a checklist and analyzed using SPSS V22. Among 824 patients, 397 (48.18%) were male and 427 (51.82%) were female with a mean age of 47 ± 6 years. The most common indications for ERCP were choledocholithiasis (78.28%) and cholestasis (20.27%), respectively. Total prevalence of complications was 15.66% and mortality rate was 0.72%. The most common complications were pancreatitis (9.59%) and bleeding (3.28%), respectively. A serum amylase level of greater than 160 could predict pancreatitis with sensitivity of 93.3% and specificity of 90.3%. Endoscopic retrograde cholangiopancreatography–related complications are inevitable but can be controlled by early diagnosis and clinical experience. Severe complications and high-risk patients may increase the mortality of the procedure.
Defining Benchmark Outcomes for Pancreatoduodenectomy With Portomesenteric Venous Resection
Authors: Raptis Dimitri A. , Sánchez-Velázquez Patricia , Machairas Nikolaos , Sauvanet Alain , Rueda de Leon Alexandra , Oba Atsushi , Groot Koerkamp Bas , Lovasik Brendan , Chan Carlos , Yeo Charles J. , Bassi Claudio , Ferrone Cristina R. , Kooby David , Moskal David , Tamburrino Domenico , Yoon Dong-Sup , Barroso Eduardo , de Santibañes Eduardo , Kauffmann Emanuele F. , Vigia Emanuel , Robin Fabien , Casciani Fabio , Burdío Fernando , Belfiori Giulio , Malleo Giuseppe , Lavu Harish , Hartog Hermien , Hwang Ho Kyuong , Han Ho-Seong , Poves Ignasi , Rosado Ismael Domínguez , Park Joon-Seong , Lillemoe Keith D. , Roberts Keith J. , Sulpice Laurent , Besselink Marc G. , Abuawwad Mahmoud , Del Chiaro Marco , de Santibañes Martin , Falconi Massimo , D'Silva Mizelle , Silva Michael , Abu Hilal Mohammed , Qadan Motaz , Sell Naomi M. , Beghdadi Nassiba , Napoli Niccolò , Busch Olivier R. C. , Mazza Oscar , Muiesan Paolo , Müller Philip C. , Ravikumar Reena , Schulick Richard , Powell-Brett Sarah , Abbas Syed Hussain , Mackay Tara M. , Stoop Thomas F. , Gallagher Tom K. , Boggi Ugo , van Eijck Casper , Clavien Pierre-Alain , Conlon Kevin C. P. , Fusai Giuseppe Kito
Published: September 2020

Objective:

The aim of this study was to establish clinically relevant outcome benchmark values using criteria for pancreatoduodenectomy (PD) with portomesenteric venous resection (PVR) from a low-risk cohort managed in high-volume centers.

Summary Background Data:

PD with PVR is regarded as the standard of care in patients with cancer involvement of the portomesenteric venous axis. There are, however, no benchmark outcome indicators for this population which hampers comparisons of patients undergoing PD with and without PVR resection.

Methods:

This multicenter study analyzed patients undergoing PD with any type of PVR in 23 high-volume centers from 2009 to 2018. Nineteen outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of the centers (NCT04053998).

Results:

Out of 1462 patients with PD and PVR, 840 (58%) formed the benchmark cohort, with a mean age was 64 (SD11) years, 413 (49%) were females. Benchmark cutoffs, among others, were calculated as follows: Clinically relevant pancreatic fistula rate (International Study Group of Pancreatic Surgery): ≤14%; in-hospital mortality rate: ≤4%; major complication rate Grade≥3 and the CCI up to 6 months postoperatively: ≤36% and ≤26, respectively; portal vein thrombosis rate: ≤14% and 5-year survival for patients with pancreatic ductal adenocarcinoma: ≥9%.

Conclusion:

These novel benchmark cutoffs targeting surgical performance, morbidity, mortality, and oncological parameters show relatively inferior results in patients undergoing vascular resection because of involvement of the portomesenteric venous axis. These benchmark values however can be used to conclusively assess the results of different centers or surgeons operating on this high-risk group.
mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors
Authors: Schnitzbauer Andreas A. , Filmann Natalie , Adam René , Bachellier Philippe , Bechstein Wolf O. , Becker Thomas , Bhoori Sherrie , Bilbao Itxarone , Brockmann Jens , Burra Patrizia , Chazoullières Olivier , Cillo Umberto , Colledan Michele , Duvoux Christoph , Ganten Tom M. , Gugenheim Jean , Heise Michael , van Hoek Bart , Jamieson Neville , de Jong Koert P. , Klein Christian G. , Klempnauer Jürgen , Kneteman Norman , Lerut Jan , Mäkisalo Heikki , Mazzaferro Vincenzo , Mirza Darius F. , Nadalin Silvio , Neuhaus Peter , Pageaux George-Philippe , Pinna Antonio D. , Pirenne Jaques , Pratschke Johann , Powel James , Rentsch Markus , Rizell Magnus , Rossi Giorgio , Rostaing Lionel , Roy André , Scholz Tim , Settmacher Utz , Soliman Thomas , Strasser Simone , Söderdahl Gunnar , Troisi Roberto I. , Turrión Victor Sánchez , Schlitt Hans J. , Geissler Edward K.
Published: September 2020

Objective:

The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).

Summary and Background Data:

Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov: NCT00355862), the effect of sirolimus on the recurrence of HCC after LT was investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data.

Patients and Methods:

Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence.

Results:

Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52–0.96,P= 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) ≥10 ng/mL and having used sirolimus for ≥3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49–0.59,P= 0.0079–0.0245).

Conclusions:

mTOR-inhibitor treatment with sirolimus for ≥3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients.

Clinical Trial Registration:

EudraCT: 2005-005362-36

Clinicaltrials.gov:

NCT00355862.
The Impact of Hospital Volume on Failure to Rescue after Liver Resection for Hepatocellular Carcinoma
Authors: Ardito Francesco , Famularo Simone , Aldrighetti Luca , Grazi Gian Luca , DallaValle Raffaele , Maestri Marcello , Jovine Elio , Ruzzenente Andrea , Baiocchi Gian Luca , Ercolani Giorgio , Griseri Guido , Frena Antonio , Zanus Giacomo , Zimmitti Giuseppe , Antonucci Adelmo , Crespi Michele , Memeo Riccardo , Romano Fabrizio , Giuliante Felice
Published: September 2020

Objective:

The aim of this study was to evaluate correlation between centers’ volume and incidence of failure to rescue (FTR) following liver resection for hepatocellular carcinoma (HCC).

Summary Background Data:

FTR, defined as the probability of postoperative death among patients with major complication, has been proposed to assess quality of care during hospitalization. Perioperative management is challenging in cirrhotic patients and the ability to recognize and treat a complication may be fundamental to rescue patients from the risk of death.

Methods:

Patients undergoing liver resection for HCC between 2008 and 2018 in 18 Centers enrolled in the He.Rc.O.Le.S. Italian register. Early results included major complications (Clavien ≥3), 90-day mortality, and FTR and were analyzed according to center's volume.

Results:

Among 1935 included patients, major complication rate was 9.4% (8.6%, 12.3%, and 7.0% for low-, intermediate- and high-volume centers, respectively, P = 0.001). Ninety-day mortality rate was 2.6% (3.7%, 4.2% and 0.9% for low-, intermediate- and high-volume centers, respectively, P < 0.001). FTR was significantly higher at low- and intermediate-volume centers (28.6% and 26.5%, respectively) than at high-volume centers (6.1%, P = 0.002). Independent predictors for major complications were American Society of Anesthesiologists (ASA) >2, portal hypertension, intraoperative blood transfusions, and center's volume. Independent predictors for 90-day mortality were ASA >2, Child-Pugh score B, BCLC stage B-C, and center's volume. Center's volume and BCLC stage were strongly associated with FTR.

Conclusions:

Risk of major complications and mortality was related with comorbidities, cirrhosis severity, and complexity of surgery. These factors were not correlated with FTR. Center's volume was the only independent predictor related with severe complications, mortality, and FTR.
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 Warfarin

Results:

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.