Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial.

OBJECTIVE: We evaluated the histamine 1 receptor antagonist ebastine as a potential treatment for patients with non-constipated irritable bowel syndrome (IBS) in a randomised, placebo-controlled phase 2 study. METHODS: Non-constipated patients with IBS fulfilling the Rome III criteria were randomly assigned to 20 mg ebastine or placebo for 12 weeks. Subjects scored global relief of symptoms (GRS) and abdominal pain intensity (API). A subject was considered a weekly responder for GRS if total or obvious relief was reported and a responder for API if the weekly average pain score was reduced by at least 30% vs baseline. The primary endpoints were the proportion of subjects who were weekly responders for at least 6 out of the 12 treatment weeks for both GRS and API ('GRS+API', composite endpoint) and for GRS and API separately. RESULTS: 202 participants (32±11 years, 68% female) were randomly allocated to receive ebastine (n=101) or placebo (n=101). Treatment with ebastine resulted in significantly more responders (12%, 12/92) for GRS+API compared with placebo (4%, 4/87, p=0.047) while the proportion of responders for GRS and API separately was higher for ebastine compared with placebo, although not statistically significant (placebo vs ebastine, GRS: 7% (6/87) vs 15% (14/91), p=0.072; API: 25% (20/85) vs 37% (34/92), p=0.081). CONCLUSIONS: Our study shows that ebastine is superior to placebo and should be further evaluated as novel treatment for patients with non-constipated IBS. TRIAL REGISTRATION NUMBER: The study protocol was approved by the local ethics committee of each study site (EudraCT number: 2013-001199-39; ClinicalTrials.gov identifier: NCT01908465).

Human cord plasma proteomic analysis reveals sexually dimorphic proteins associated with intrauterine growth restriction.

Intrauterine growth restriction (IUGR) is associated with increased risk of cardiometabolic disease later in life and has been shown to affect female and male offspring differently, but the mechanisms remain unclear. The purpose of this study was to identify proteomic differences and metabolic risk markers in IUGR male and female neonates when compared to appropriate for gestational age (AGA) babies that will provide a better understanding of IUGR pathogenesis and its associated risks. Our results revealed alterations in IUGR cord plasma proteomes with most of the differentially abundant proteins implicated in peroxisome pathways. This effect was evident in females but not in males. Furthermore, we observed that catalase activity, a peroxisomal enzyme, was significantly increased in females (p < 0.05) but unchanged in males. Finally, we identified risk proteins associated with obesity, type-2 diabetes, and glucose intolerance such as EGF containing fibulin extracellular matrix protein 1 (EFEMP1), proprotein convertase subtilisin/kexin type 9 (PCSK9) and transforming growth factor beta receptor 3 (TGFBR3) proteins unique to females while coagulation factor IX (C9) and retinol binding protein 4 (RBP4) are unique in males. In conclusion, IUGR may display sexual dimorphism which may be associated with differences in lifelong risk for cardiometabolic disease between males and females.

Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial).

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.

The effect of adipose-derived stem cells on enthesis healing after repair of acute and chronic massive rotator cuff tears in rats.

BACKGROUND: Chronic massive rotator cuff tears heal poorly and often retear. This study investigated the effect of adipose-derived stem cells (ADSCs) and transforming growth factor-ß3 (TGF-ß3) delivered in 1 of 2 hydrogels (fibrin or gelatin methacrylate [GelMA]) on enthesis healing after repair of acute or chronic massive rotator cuff tears in rats. METHODS: Adult male Lewis rats underwent bilateral transection of the supraspinatus and infraspinatus tendons with intramuscular injection of botulinum toxin A (n = 48 rats). After 8 weeks, animals received 1 of 8 interventions (n = 12 shoulders/group): (1) no repair, (2) repair only, or repair augmented with (3) fibrin, (4) GelMA, (5) fibrin + ADSCs, (6) GelMA + ADSCs, (7) fibrin + ADSCs + TGF-ß3, or (8) GelMA + ADSCs + TGF-ß3. An equal number of animals underwent acute tendon transection and immediate application of 1 of 8 interventions. Enthesis healing was evaluated 4 weeks after the repair by microcomputed tomography, histology, and mechanical testing. RESULTS: Increased bone loss and reduced structural properties were seen in chronic compared with acute tears. Bone mineral density of the proximal humerus was higher in repairs of chronic tears augmented with fibrin + ADSCs and GelMA + ADSCs than in unrepaired chronic tears. Similar improvement was not seen in acute tears. No intervention enhanced histologic appearance or structural properties in acute or chronic tears. CONCLUSIONS: Surgical repair augmented with ADSCs may provide more benefit in chronic tears compared with acute tears, although there was no added benefit to supplementing ADSCs with TGF-ß3.

Rates of and Risk Factors for Adverse Drug Events in Outpatient Parenteral Antimicrobial Therapy.

Background: To better monitor patients on outpatient parenteral antimicrobial therapy (OPAT), we need an improved understanding of risk factors for and timing of OPAT-associated adverse drug events (ADEs). Methods: We analyzed a prospective cohort of patients on OPAT discharged from 2 academic medical centers. Patients underwent chart abstraction and a telephone survey. Multivariable analyses estimated adjusted incident rate ratios (aIRR) between clinical and demographic risk factors and clinician-determined clinically significant ADEs. Descriptive data were used to present patient-reported ADEs. Results: Of 339 patients enrolled in the study, 18.0% experienced an ADE (N = 65), of which 49 were significant (14.5%, 2.24/1000 home-OPAT days). Patients with longer courses of therapy had lower rates of ADEs compared with patients treated for 0-13 days (14-27 days: aIRR, 0.44; 95% confidence interval [CI], 0.20-0.99; at least 28 days: aIRR, 0.11; 95% CI, 0.056-0.21). Risk factors for ADEs included female gender and receipt of daptomycin or vancomycin, while treatment for uncomplicated bacteremia and empiric treatment were associated with lower rates of ADEs. Conclusions: OPAT-related ADEs were common and often occurred within 2 weeks of hospital discharge. Patients on OPAT should be monitored more closely for ADEs, including clinical assessment and laboratory monitoring, especially within the first weeks after hospital discharge and particularly among women and patients who receive vancomycin.

Optimizing Functional Outcomes in Mandibular Condyle Reconstruction With the Free Fibula Flap Using Computer-Aided Design and Manufacturing Technology.

PURPOSE: Mandibular defects involving the condyle represent a complex reconstructive challenge for restoring proper function of the temporomandibular joint (TMJ) because it requires precise bone graft alignment for full restoration of joint function. The use of computer-aided design and manufacturing (CAD/CAM) technology can aid in accurate reconstruction of mandibular condyle defects with a vascularized free fibula flap without the need for additional adjuncts. The purpose of this study was to analyze clinical and functional outcomes after reconstruction of mandibular condyle defects using only a free fibula graft with the help of virtual surgery techniques. MATERIALS AND METHODS: A retrospective review was performed to identify all patients who underwent mandibular reconstruction with only a free fibula flap without any TMJ adjuncts after a total condylectomy. Three-dimensional modeling software was used to plan and execute reconstruction for all patients. RESULTS: From 2009 through 2014, 14 patients underwent reconstruction of mandibular defects involving the condyle with the aid of virtual surgery technology. The average age was 38.7 years (range, 11 to 77 yr). The average follow-up period was 2.6 years (range, 0.8 to 4.2 yr). Flap survival was 100% (N = 14). All patients reported improved facial symmetry, adequate jaw opening, and normal dental occlusion. In addition, they achieved good functional outcomes, including normal intelligible speech and the tolerance of a regular diet with solid foods. Maximal interincisal opening range for all patients was 25 to 38 mm with no lateral deviation or subjective joint pain. No patient had progressive joint hypomobility or condylar migration. One patient had ankylosis, which required release. CONCLUSION: TMJ reconstruction poses considerable challenges in bone graft alignment for full restoration of joint function. The use of CAD/CAM technology can aid in accurate reconstruction of mandibular condyle defects with a vascularized free fibula flap through precise planning and intraoperative manipulation with optimal functional outcomes.

A Modified Approach to Extensive Oromandibular Reconstruction Using Free Fibula Flaps.

In select patients with advanced disease resulting in large composite tissue defects, consideration is often given to multiple flap reconstruction. The authors propose an alternative option. Using virtual surgical planning the authors demonstrate how modest sacrifice in projection translates into a substantial decrease in the volume and surface area of soft tissue needed, in turn maximizing soft tissue coverage with a single fibula free flap. The authors used 3-dimensional virtual surgery to simulate angle-to-angle reconstructions using free fibula flaps. The reference 3-segment reconstruction was done using symphyseal projection to the plane perpendicular to the anterior nasal spine, a customary landmark. Additional simulations were then performed using recessed projections 0.5 mm, 1 cm, 1.5 cm, and 2 cm posterior to anterior nasal spine plane. Program analytics were used to calculate the surface area and volume of the floor of mouth. With projection recessed by 1 cm, surface area decreased 22% to 14 cm. With projection recessed by 2 cm, surface area decreased 44% to 10 cm. With a 3-segment construct converted to a 2-segment construct, surface area decreased 22% to 14 cm. This demonstrates for the first time an official analysis of an intraoperative modification that sacrifices little and gains a lot. Ultimately, 1 compound flap can be used in extensive reconstructions with increased confidence that it will not be overly stressed.

Reconstruction of Congenital Mandibular Hypoplasia With Microvascular Free Fibula Flaps in the Pediatric Population: A Paradigm Shift.

BACKGROUND: The microvascular free fibula flap has become the gold standard for reconstruction of complex mandibular defects since its description by Hidalgo in 1989. Prior studies have demonstrated its safety and efficacy in the pediatric population. However, this reconstructive method is often used only as a last resort for correction of congenital mandibular hypoplasia, after failure of bone grafting and distraction osteogenesis. The authors describe our experience using this technique, facilitated by virtual planning and prefabricated cutting jigs, for children with severe congenital mandibular hypoplasia. METHODS: All patients with mandibular reconstruction with a fibula flap in children with congenital mandibular hypoplasia between 2009 and 2014 by the senior authors were identified. Each patient underwent preoperative computed tomography scanning and virtual surgical planning to create custom cutting jigs for creation of the mandibular defect and fibular osteotomies. Preoperative, intraoperative, and postoperative medical records were examined in detail. RESULTS: Five patients age 10 to 18 with congenital mandibular hypoplasia and Pruzansky Grade III mandibles underwent microvascular free fibula flap for mandibular reconstruction during this period. Flap success rate was 100%. All patients underwent subsequent revision procedures to improve symmetry or for hardware removal. The 4 patients in our series who required dental implants were able to have them placed into their mandibular reconstruction. CONCLUSIONS: Preoperative virtual planning and prefabricated cutting jigs allow for precise complex fibula reconstruction of the mandible in the pediatric population. Additionally, virtual planning facilitates concomitant orthognathic procedures in patients with hemifacial microsomia. Our early success in this patient population leads us to suggest that while the free fibula can be safely and successfully used after multiple prior surgical interventions in the same anatomic region, it can also be a powerful tool for primary correction of congenital mandibular hypoplasia.

Jaw in a Day: State of the Art in Maxillary Reconstruction.

BACKGROUND: Reconstruction of maxillary defects following tumor extirpation is challenging because of combined aesthetic and functional roles of the maxilla. One-stage reconstruction combining osseous free flaps with immediate osseointegrated implants are becoming the standard for mandibular defects, and have similar potential for maxillary reconstruction. METHODS: A woman with maxillary Ewing sarcoma successfully treated at age 9 with neoadjuvant chemotherapy, right hemimaxillectomy, and obturator prosthetic reconstruction presented for definitive reconstruction, complaining of poor obturator fit, and hypernasality. Her reconstruction was computer-simulated by a multidisciplinary team, consisting of left hemi-Lefort I advancement and right maxillary reconstruction with a free fibula flap with immediate osseointegrated implants and dental prosthesis. RESULTS: Full dental restoration, midface projection, and oral fistula corrections were achieved in 1 operative stage using this approach. CONCLUSIONS: This patient demonstrates a successful approach for maxillary reconstruction using computer-planned orthognathic surgery with free fibula reconstruction and immediate osseointegrated implants with dental prosthesis.

Salivary duct carcinoma ex pleomorphic adenoma of the palate: a case report.

Carcinoma ex pleomorphic adenoma is a rare malignancy of the head and neck, particularly in the minor salivary glands. Most cases arise in the major salivary glands, most commonly in the parotid gland, followed by the submandibular gland. The malignant component of the tumor varies, but can be salivary duct carcinoma, adenoid cystic carcinoma, mucoepidermoid carcinoma, squamous cell carcinoma, or adenocarcinoma, not otherwise specified. Primary salivary duct carcinoma is also a rare malignancy of the head and neck. Similar to carcinoma ex pleomorphic adenoma, it is more common in the major salivary glands, with the parotid gland accounting for 88% and the submandibular gland for 10% of cases. To date, only 25 known cases of primary salivary duct carcinoma arising in the minor salivary glands have been documented, with most arising in the palate. Salivary duct carcinoma ex pleomorphic adenoma of the minor salivary glands appears to be even rarer. Our case of salivary duct carcinoma ex pleomorphic adenoma of the palate is the first complete report, to our knowledge, in the English-language scientific literature.

The Reliability of Ultrasound Measurements of the Median Nerve at the Carpal Tunnel Inlet.

PURPOSE: To determine the interrater and intra-rater reliability of ultrasound (US) measurement of the cross-sectional area (CSA) of the median nerve at the carpal tunnel inlet. METHODS: Three examiners of varying levels of experience performed US measurements of the CSA of the median nerve at the carpal tunnel inlet of both wrists of 11 healthy volunteers. Each examiner was blinded to the measurements of the other examiners. The measurements were repeated 2 weeks later in random order to test intra-rater reliability. The Lin concordance correlation coefficient (LCCC) for interrater and intra-rater reliability was calculated. RESULTS: The overall inter-rater LCCC was 0.59 (95% confidence interval [CI], 0.41-0.73). Intra-rater LCCC varied based on examiner experience. The senior author had an intra-rater LCCC of 0.91 (95% CI, 0.80-0.96), the hand fellow had an intra-rater LCCC of 0.45 (95% CI, 0.17-0.66), and the first-year resident had an intra-rater LCCC of 0.78 (95% CI, 0.55-0.90). CONCLUSIONS: There is moderate agreement among examiners of varying levels of experience when measuring the CSA of the median nerve at the carpal tunnel inlet. Examiner experience affected intra-rater reliability of measurements; an experienced examiner had nearly perfect agreement compared with moderate agreement for less experienced examiners.

Effectiveness of Arthroscopic Debridement, Trapeziectomy, and Joint Replacement for Trapeziometacarpal Joint Osteoarthritis: A Meta-Analysis of Pre and Postoperative Pain Scores.

Trapeziometacarpal joint osteoarthritis (TMJO) affects up to 33% of postmenopausal women, leading to pain, reduced mobility, and grip strength, with initial treatments focusing on non-surgical options like injections, orthoses, and exercises before considering surgery. A major challenge in managing TMJO involves selecting the optimal surgical strategy that is customized to individual clinical conditions. This study aimed to compare the effectiveness of three common surgical interventions for TMJO in relieving pain, including arthroscopic debridement (AD), trapeziectomy (TRAP), and joint replacement (JR). PubMed, Cochrane, Embase, and MEDLINE databases were queried according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for studies that presented pain outcomes following intervention for TMJO. Pain scores were reported preoperatively and postoperatively using the visual analog scale (VAS). Inclusion criteria included studies published in Q1 and Q2 journals and those with a follow-up of > six months. The final selection comprised 18 studies with 763 patients treated with AD (n = 102, 13%), TRAP (n = 428, 56%), and JR (n = 233, 31%) between 2010 and 2023, with a mean follow-up period of 38 ± 28 months. The studies included a total of 24 groups, five of which received AD, 13 of which received TRAP, and six of which received JR. The mean preoperative VAS was 6.7 ± 1.7, and the mean postoperative VAS was 1.7 ± 1.3 for all groups (P < 0.001). The meta-analysis demonstrated a mean preoperative pain score of 5.8 (95% CI, 4.1-7.5) for AD, 6.6 (95% CI, 5.7-7.5) for TRAP, and 7.8 (95% CI, 7.0-8.7) for JR. Postoperatively, there was a mean pain score of 2.2 (95% CI, 0.1-4.2) for AD, 1.4 (95% CI, 1.1-1.7) for TRAP, and 0.9 (95% CI, 0.6-1.2) for JR. This study showed that, if appropriately indicated, joint preservation with AD may be as effective as TRAP and JR for reducing pain associated with TMJO in the short term. However, the rate of conversion or revision should be assessed in future studies.

Total Shoulder Arthroplasty is associated With Less Pain and Better Functional Outcomes, but Humeral Head Resurfacing may be Preferred in Younger, Higher Demand Patients: A Short-Term Outcomes Study in Patients with Glenohumeral Osteoarthritis.

Objectives: This study aimed to compare short-term outcomes following Total Shoulder Arthroplasty (TSA) and Humeral Head Resurfacing (HHR) in patients with glenohumeral osteoarthritis (GHOA). Methods: A retrospective analysis included patients who had undergone either TSA or HHR for GHOA at a single institution. Baseline demographics, complications, range of motion (active forward flexion, FF and active external rotation, ER), visual analog scores (VAS), and Subjective Shoulder Values (SSV) were collected. Results: A total of 69 TSA and 56 HHR patients were analyzed. More HHR patients were laborers (44% versus 21%, P=0.01). There were more smokers in the TSA group (25% versus 11%, P=0.04) and more cardiovascular disease in the HHR cohort (64% versus. 6%, p<0.0001). Postoperative FF was similar, but ER was greater in the HHR (47° ± 15°) vs. TSA group (40° ± 12°, P = 0.01). VAS was lower after TSA vs. HHR (median 0, IQR 1 versus median 3.7, IQR 6.9, p<0.0001), and SSV was higher after TSA (89% ± 13% vs. 75% ± 20% after HHR; p<0.0001). Post-operative impingement was more common after HHR (32% vs. 3% for TSA, p<0.0001). All other complications were equivalent. Conclusion: While younger patients and heavy laborers had improved ER following HHR, their pain relief was greater after TSA. Decisions on surgical technique should be based on patient-specific demographic and anatomic factors.

Efficacy of treatment for patients with achalasia depends on the distensibility of the esophagogastric junction.

BACKGROUND & AIMS: Many patients with persistent dysphagia and regurgitation after therapy have low or no lower esophageal sphincter (LES) pressure. Distensibility of the esophagogastric junction (EGJ) largely determines esophageal emptying. We investigated whether assessment of the distensibility of the EGJ is a better and more integrated parameter than LES pressure for determining efficacy of treatment for patients with achalasia. METHODS: We measured distensibility of the EGJ using an endoscopic functional luminal imaging probe (EndoFLIP) in 15 healthy volunteers (controls; 8 male; age, 40 ± 4.1 years) and 30 patients with achalasia (16 male; age, 51 ± 3.1 years). Patients were also assessed by esophageal manometry and a timed barium esophagogram. Symptom scores were assessed using the Eckardt score, with a score <4 indicating treatment success. The effect of initial and additional treatment on distensibility and symptoms was evaluated in 7 and 5 patients, respectively. RESULTS: EGJ distensibility was significantly reduced in untreated patients with achalasia compared with controls (0.7 ± 0.9 vs 6.3 ± 0.7 mm(2)/mm Hg; P < .001). In patients with achalasia, EGJ distensibility correlated with esophageal emptying (r = -0.72; P < .01) and symptoms (r = 0.61; P < .01) and was significantly increased with treatment. EGJ distensibility was significantly higher in patients successfully treated (Eckardt score <3) compared with those with an Eckardt score >3 (1.6 ± 0.3 vs 4.4 ± 0.5 mm(2)/mm Hg; P = .001). Even when LES pressure was low, EGJ distensibility could be reduced, which was associated with impaired emptying and recurrent symptoms. CONCLUSIONS: EGJ distensibility is impaired in patients with achalasia and, in contrast to LES pressure, is associated with esophageal emptying and clinical response. Assessment of EGJ distensibility by EndoFLIP is a better parameter than LES pressure for evaluating efficacy of treatment for achalasia.

Accuracy of a computer-aided surgical simulation protocol for orthognathic surgery: a prospective multicenter study.

PURPOSE: The purpose of this prospective multicenter study was to assess the accuracy of a computer-aided surgical simulation (CASS) protocol for orthognathic surgery. MATERIALS AND METHODS: The accuracy of the CASS protocol was assessed by comparing planned outcomes with postoperative outcomes of 65 consecutive patients enrolled from 3 centers. Computer-generated surgical splints were used for all patients. For the genioplasty, 1 center used computer-generated chin templates to reposition the chin segment only for patients with asymmetry. Standard intraoperative measurements were used without the chin templates for the remaining patients. The primary outcome measurements were the linear and angular differences for the maxilla, mandible, and chin when the planned and postoperative models were registered at the cranium. The secondary outcome measurements were the maxillary dental midline difference between the planned and postoperative positions and the linear and angular differences of the chin segment between the groups with and without the use of the template. The latter were measured when the planned and postoperative models were registered at the mandibular body. Statistical analyses were performed, and the accuracy was reported using root mean square deviation (RMSD) and the Bland-Altman method for assessing measurement agreement. RESULTS: In the primary outcome measurements, there was no statistically significant difference among the 3 centers for the maxilla and mandible. The largest RMSDs were 1.0 mm and 1.5° for the maxilla and 1.1 mm and 1.8° for the mandible. For the chin, there was a statistically significant difference between the groups with and without the use of the chin template. The chin template group showed excellent accuracy, with the largest positional RMSD of 1.0 mm and the largest orientation RMSD of 2.2°. However, larger variances were observed in the group not using the chin template. This was significant in the anteroposterior and superoinferior directions and the in pitch and yaw orientations. In the secondary outcome measurements, the RMSD of the maxillary dental midline positions was 0.9 mm. When registered at the body of the mandible, the linear and angular differences of the chin segment between the groups with and without the use of the chin template were consistent with the results found in the primary outcome measurements. CONCLUSIONS: Using this computer-aided surgical simulation protocol, the computerized plan can be transferred accurately and consistently to the patient to position the maxilla and mandible at the time of surgery. The computer-generated chin template provides greater accuracy in repositioning the chin segment than the intraoperative measurements.

A novel approach to frontal sinus surgery: treatment algorithm revisited.

BACKGROUND: Access to the frontal sinus remains a challenging problem for the craniofacial surgeon. A wide array of techniques including minimally invasive endoscopic approaches have been described. Here we present our technique using medical modeling to gain fast and safe access for multiple indications. METHODS: Computer-aided surgery involves several distinct phases: planning, modeling, surgery, and evaluation. Computer-aided, precise cutting guides are designed preoperatively and allowed to perfectly outline and then cut the anterior table of the frontal sinus at its junction to the surrounding frontal bone. The outcomes are evaluated by postoperative three-dimensional computed tomography scan. RESULTS: Eight patients sustaining frontal sinus fractures were treated with the aid of medical modeling. Three patients (37.5%) had isolated anterior table fractures, and 4 (50%) had combined anterior and posterior table fractures, whereas 1 patient (12.5%) sustained isolated posterior table fractures. Operative times were significantly shorter using the cutting guides, and fracture reduction was more precise. There was no statistically significant difference in complication rates or overall patient satisfaction. CONCLUSIONS: The surgical approach to the frontal sinus can be made more efficient, safe, and precise when using computer-aided medical modeling to create customized cutting guides.

Ten-year evolution utilizing computer-assisted reconstruction for giant ameloblastoma.

BACKGROUND: The authors describe our current practice of computer-aided virtual planned and pre-executed surgeries using microvascular free tissue transfer with immediate placement of implants and dental prosthetics. METHODS: All patients with ameloblastomas treated at New York University (NYU) Medical Center during a 10-year period from September 2001 to December 2011 were identified. Of the 38 (36 mandible/2 maxilla) patients that were treated in this time period, 20 were identified with advanced disease (giant ameloblastoma) requiring aggressive resection. Reconstruction of the resultant defects utilized microvascular free tissue transfer with an osseocutaneous fibular flap in all 20 of these patients. RESULTS: Of the patients reconstructed with free vascularized tissue transfer, 35% (7/20) developed complications. There were two complete flap failures with consequent contralateral fibula flap placement. Sixteen patients to date have undergone placement of endosteal implants for complete dental rehabilitation, nine of which received immediate placement of the implants at the time of the free flap reconstruction. The three most recent patients received immediate placement of dental implants at the time of microvascular free tissue transfer as well as concurrent placement of dental prosthesis. CONCLUSIONS: To our knowledge, this patient cohort represents the largest series of comprehensive computer aided free-flap reconstruction with dental restoration for giant type ameloblastoma.

Predatory Journals in Orthopaedic Surgery.

The prevalence of predatory journals in orthopaedic surgery continues to increase. These journals directly solicit authors, offering the advantages of open access and quick publication rates. Solicitation typically occurs in the form of e-mail communications, and the targets are usually identified as authors who have published other works in conventional publications. These predatory journals process manuscripts without peer review and plagiarism checks and often for a substantial publication fee. As a result, the scientific value of these publications is grossly suspect and has been considered a substantial threat to the quality of scientific discourse and scholarship. This affects not only the layperson reading the works but also investigators tricked into publishing in these venues. It has been estimated that several million US dollars per year are spent on these publications and, in many instances, using monies granted by agencies such as the National Institutes of Health. This review aims to study the types of solicitation, evaluate the increasing prevalence in orthopaedic surgery, and offer methods to authors and readers to identify these journals to mitigate their negative effects.

International Consensus Recommendation Guidelines for Subcutaneous Infusions of Hydration and Medication in Adults: An e-Delphi Consensus Study.

Infusion of fluids and medications is traditionally performed intravenously. However, venous depletion in patients has led to the quest for vessel health preservation. A safe, effective, acceptable, and efficient alternative is the subcutaneous route. A lack of organizational policies may contribute to the slow uptake of this practice. This modified e-Delphi (electronic) study aimed to derive international consensus on practice recommendations for subcutaneous infusions of fluids and medications. A panel of 11 international clinicians, with expertise in subcutaneous infusion research and/or clinical practice, rated and edited subcutaneous infusion practice recommendations from evidence, clinical practice guidelines, and clinical expertise within an Assessment, Best Practice, and Competency (ABC) domain guideline model. The ABC Model for Subcutaneous Infusion Therapy provides a systematic guideline of 42 practice recommendations for the safe delivery of subcutaneous infusions of fluids and medications in the adult population in all care settings. These consensus recommendations provide a guideline for health care providers, organizations, and policy makers to optimize use of the subcutaneous access route.

Squamous cell carcinoma of the oral cavity in nonsmoking women: a new and unusual complication of chemotherapy for recurrent ovarian cancer?

PURPOSE: To describe occurrences of oral squamous cell carcinoma (SCC) in patients who had received long-term pegylated liposomal doxorubicin (PLD) for ovarian cancer. PATIENTS AND METHODS: In our cohort of patients on maintenance PLD for ovarian and related mullerian epithelial malignancies, we encountered two patients with invasive SCC of the oral cavity (one of them multifocal) and one with high-grade squamous dysplasia. Review of patients at our institution receiving PLD for recurrent ovarian cancer identified three additional patients. The duration of treatment, cumulative PLD dose, human papillomavirus (HPV) positivity, BRCA status, stage at diagnosis, outcome, and other characteristics are reviewed. RESULTS: All five cases were nonsmokers with no known risk factors for HPV and four were negative for p16 expression. Four of the patients had known BRCA mutations whereas one tested negative. Cumulative doses of PLD were >1,600 mg/m2 given over 30-132 months. Three had SCCs staged as T1N0 oral tongue, alveolar ridge (gingival), and multifocal oral mucosa; one had a T2N0 oral tongue; and one had dysplasia. After excision, two were given radiation but recurred shortly thereafter; the others remain well and have had no further exposure to cytotoxic drugs, including PLD. CONCLUSION: Awareness of this possible long-term complication during PLD treatment should enhance the likelihood of early detection of oral lesions in these patients. Decisions to continue maintenance PLD after complete response of the original cancer should perhaps consider the benefits of delaying ovarian cancer recurrence versus the possible risk for a secondary cancer.