Editor's Choice - Short Term Cost Effectiveness of Radiofrequency Ablation and High Ligation and Stripping for Great Saphenous Vein Incompetence.

OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as €1 292 for RFA and €2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was €6 155 for RFA and €13 549 for HL/S. With added cost for days absent from work the cost per QALY was €7 358 for RFA and €24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.

Assessment of liver function by gadoxetic acid avidity in MRI in a model of rapid liver regeneration in rats.

BACKGROUND: This animal study investigates the hypothesis of an immature liver growth following ALPPS (associating liver partition and portal vein ligation for staged hepatectomy) by measuring liver volume and function using gadoxetic acid avidity in magnetic resonance imaging (MRI) in models of ALPPS, major liver resection (LR) and portal vein ligation (PVL). METHODS: Wistar rats were randomly allocated to ALPPS, LR or PVL. In contrast-enhanced MRI scans with gadoxetic acid (Primovist®), liver volume and function of the right median lobe (=future liver remnant, FLR) and the deportalized lobes (DPL) were assessed until post-operative day (POD) 5. Liver functionFLR/DPL was defined as the inverse value of time from injection of gadoxetic acid to the blood pool-corrected maximum signal intensityFLR/DPL multiplied by the volumeFLR/DPL. RESULTS: In ALPPS (n = 6), LR (n = 6) and PVL (n = 6), volumeFLR and functionFLR increased proportionally, except on POD 1. Thereafter, functionFLR exceeded volumeFLR increase in LR and ALPPS, but not in PVL. Total liver function was significantly reduced after LR until POD 3, but never undercuts 60% of its pre-operative value following ALPPS and PVL. DISCUSSION: This study shows for the first time that functional increase is proportional to volume increase in ALPPS using gadoxetic acid avidity in MRI.

A low-cost prosthetic orbital simulation model for endoscopic anterior ethmoid artery ligation.

OBJECTIVE: This study aimed to develop and evaluate a low-cost orbital prosthesis for simulation of endoscopically assisted intra-orbital anterior ethmoidal artery ligation. METHODS: A low-cost orbital prosthesis was built and evaluated by ENT surgical trainees. Feedback was given following the assessment in the form of a face validity questionnaire. RESULTS: Results were scored on a Likert scale of 1-7 (low to high). Trainees had limited exposure to the procedure (40 per cent) and predominantly low levels of confidence (mean, 3.67) that correlated with a lack of first-hand experience. The anatomy and likeness to human tissue of the prosthesis were both ranked highly, with mean scores of 5.0 and 4.93, respectively. CONCLUSION: The results of this study support the idea that a simple anatomical prosthesis for the simulation of endoscopic anterior ethmoidal artery ligation can be created with potential value to otolaryngology surgical training. To the authors' knowledge, this is the first documentation of simulated surgical epistaxis management using an artificial anatomical model.

Protocol for the ORION trial (RadiO fRequency ablatION for haemorrhoids): a randomised controlled trial.

BACKGROUND: Haemorrhoids are common and can significantly impact the personal and working lives of individuals. Those with more severe symptoms and those not responding to conservative management may require surgery. Current surgical techniques are associated with a degree of postoperative discomfort which may delay return to normal activity. Recurrence is lower in more radical procedures but resulting pain is higher. Radiofrequency ablation (RFA) is a new technique that is gaining popularity and has several hypothesised benefits, including reduced pain and recurrence. However, available evidence is limited. A recent overview from the National Institute for Health and Clinical Excellence recommended more research, in the form of randomised controlled trials, be carried out before further investment is made by national health services. Our aim is to assess whether RFA is at least as good in terms of recurrence as existing surgical interventions, but superior in terms of pain, for patients with symptomatic grade II and III haemorrhoids. METHODS: The RadiO fRequency ablatION for haemorrhoids (ORION) trial will be a pragmatic multicentre patient/assessor-blind parallel group-controlled trial with economic evaluation. The target sample size is 376 participants (188 per arm) and is based on two co-primary endpoints: (i) a non-inferiority design for recurrence and (ii) superiority design for pain at seven days. Participants with grade II or III haemorrhoids will be recruited in 16 National Health Service hospitals and randomised (1:1) to either RFA or surgeon's choice of surgery. CONCLUSIONS: Results will inform future practice for the treatment of grade II-III haemorrhoids and provide evidence for national health services on future investments in RFA. TRIAL REGISTRATION: ISRCTN14474552.

Development of a procedure-specific tool for skill assessment in left- and right-sided laparoscopic complete mesocolic excision.

AIM: To (1) develop an assessment tool for laparoscopic complete mesocolic excision (LCME) and (2) report evidence of its content validity. METHOD: Assessment statements were revealed through (1) semi-structured expert interviews and (2) consensus by the Delphi method, both involving an expert panel of five LCME surgeons. All experts were interviewed and then asked to rate LCME describing statements from 1 (strongly disagree) to 5 (strongly agree). Responses were returned anonymously to the panel until consensus was reached. Statements were directly included as content in the assessment tool if ≥60% of the experts responded "agree" or "strongly agree" (ratings 4 and 5), with the remaining responses being "neither agree nor disagree" (rating 3). Interclass correlation coefficient (ICC) was calculated for expert agreement evaluation. All included statements were subsequently reformulated as tool items and approved by the experts. RESULTS: Four Delphi rounds were performed to reach consensus. Disagreement was reported for statements describing instrument handling around pancreas; visualisation of landmarks before inferior mesenteric artery ligation; lymphadenectomy around the inferior mesenteric artery, and division of the terminal ileum and transverse colon. ICC in the last Delphi-round was 0.84. The final tool content included 73 statements, converted to 48 right- and 40 left-sided items for LCME assessment. CONCLUSION: A procedure-specific, video-based tool, named complete mesocolic excision competency assessment tool (CMECAT), has been developed for LCME skill assessment. In the future, we hope it can facilitate assessment of LCME surgeons, resulting in improved patient outcome after colon cancer surgery.

Assessment and Interventions for Vascular Injuries Associated With Fractures.

Vascular injuries associated with fractures are limb-threatening injuries with notable morbidity. The prompt and thorough evaluation of these patients is imperative to diagnose vascular injuries, and coordinated multidisciplinary care is needed to provide optimal outcomes. The initial assessment includes a detailed physical examination assessing for hard and soft signs of arterial injury, and the arterial pressure index can be used to reliably identify vascular compromise and the need for additional assessment or intervention. Advanced imaging in the form of CT angiography is highly sensitive in additional characterization of the potential injury and can be obtained in an expedient manner. The optimal treatment of fractures with vascular injuries includes providing skeletal stability and confirming or reestablishing adequate distal perfusion as soon as possible. Options for vascular intervention include observation, ligation, direct arterial repair, vascular bypass grafting, endovascular intervention, and staged temporary shunting, followed by bypass grafting. Although the optimal sequence of surgical intervention remains an incompletely answered question, the orthopaedic role in the care of patients with these injuries is to provide mechanical stability to the injured limb to protect the vascular repair and surrounding soft-tissue envelope.

Assessment of Sumatriptan on Sepsis-Induced Kidney injury in the Cecal Ligation and Puncture Mice Model.

Sepsis is a severe systemic inflammatory response with high mortality rate resulting from different microorganisms. Cytokines activation is essential for the immune response, but in painful conditions like sepsis, cytokines act as a double-edged sword and dysregulate immune response which is life-threatening owing to multiple organ dysfunction. The abnormality in 5-HT function is involved in pathological conditions like irritable bowel syndrome, inflammation, myocardial ischemia, itch and renal injury. Sumatriptan, a 5-HT1B/1D agonist, has anti-inflammatory and anti-oxidative stress effects on animal models. This study was aimed to assess the effects of sumatriptan on kidney injury, the levels of pro-inflammatory cytokines and the percentage of survival in (CLP)-induced sepsis were examined.Cecal ligation and puncture (CLP) model was done on adult C57BL/6 male mice to induce Polymicrobial sepsis. Sumatriptan was injected intraperitoneally 1 h after the sepsis induction by CLP at doses of 0.1, 0.3, and 1 mg/kg in 3 treatment groups. To study the effect of sumatriptan on short-term survival, septic animals were detected 72 h after CLP. Serum levels of TNF-α, IL-1ß, IL-6 and IL-10 were evaluated. To study sepsis-induced acute renal failure, kidney functional biomarkers and histopathological alterations were evaluated.Sumatriptan (0.3 mg/kg) administration significantly enhanced survival rate (P<0.01) compared to the CLP group. The beneficial effects of sumatriptan were related to a significant decrease in the pro-inflammatory cytokines and elevated level of IL-10. Sumatriptan presented protective effects on kidney biomarkers and histopathology assay.Anti-inflammatory effects of sumatriptan lead to decrease mortality rate and inflammatory cytokines in CLP induction sepsis in C57BL/6 mice.

Incidence and Characterization of Rectal Complications From Fecal Management Systems.

BACKGROUND: Fecal management systems have become ubiquitous in hospitalized patients with fecal incontinence or severe diarrhea, especially in the setting of perianal wounds. Although fecal management system use has been shown to be safe and effective in initial series, case reports of rectal ulceration and severe bleeding have been reported, with a relative paucity of clinical safety data in the literature. OBJECTIVE: The purpose of this study was to determine the rate of rectal complications attributable to fecal management systems, as well as to characterize possible risk factors and appropriate management strategies for such complications. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at a large academic medical center. PATIENTS: All medical and surgical patients who underwent fecal management system placement from December 2014 to March 2017 were included. MAIN OUTCOME MEASURES: We measured any rectal complication associated with fecal management system use, defined as any rectal injury identified after fecal management system use confirmed by lower endoscopy. RESULTS: A total of 629 patients were captured, with a median duration of fecal management system use of 4 days. Overall, 8 patients (1.3%) experienced a rectal injury associated with fecal management system use. All of the patients who experienced a rectal complication had severe underlying comorbidities, including 2 patients on dialysis, 1 patient with cirrhosis, and 3 patients with a recent history of emergent cardiac surgery. In 3 patients the bleeding resolved spontaneously, whereas the remaining 5 patients required intervention: transanal suture ligation (n = 2), endoscopic clip placement (n = 1), rectal packing (n = 1), and proctectomy in 1 patient with a history of pelvic radiotherapy. LIMITATIONS: The study was limited by its retrospective design and single institution. CONCLUSIONS: This is the largest study to date evaluating rectal complications from fecal management system use. Although rectal injury rates are low, they can lead to serious morbidity. Advanced age, severe comorbidities, pelvic radiotherapy, and anticoagulation status or coagulopathy are important factors to consider before fecal management system placement. See Video Abstract at http://links.lww.com/DCR/B698. INCIDENCIA Y CARACTERIZACIN DE LAS COMPLICACIONES RECTALES DE LOS SISTEMAS DE MANEJO FECAL: ANTECEDENTES:Los sistemas de manejo fecal se han vuelto omnipresentes en pacientes hospitalizados con incontinencia fecal o diarrea severa, especialmente en el contexto de heridas perianales. Aunque se ha demostrado que el uso del sistema de tratamiento fecal es seguro y eficaz en la serie inicial, se han notificado casos de ulceración rectal y hemorragia grave, con una relativa escasez de datos de seguridad clínica en la literatura.OBJETIVO:Determinar la tasa de complicaciones rectales atribuibles a los sistemas de manejo fecal. Caracterizar los posibles factores de riesgo y las estrategias de manejo adecuadas para tales complicaciones.DISEÑO:Estudio de cohorte retrospectivo.ENTORNO CLINICO:Centro médico académico de mayor volumen.PACIENTES:Todos los pacientes médicos y quirúrgicos que se sometieron a la colocación del sistema de manejo fecal desde diciembre de 2014 hasta marzo de 2017.PRINCIPALES MEDIDAS DE VALORACION:Cualquier complicación rectal asociada con el uso del sistema de manejo fecal, definida como cualquier lesión rectal identificada después del uso del sistema de manejo fecal confirmada por endoscopia baja.RESULTADOS:Se identificaron un total de 629 pacientes, con una duración media del uso del sistema de manejo fecal de 4,0 días. En general, 8 (1,3%) pacientes desarrollaron una lesión rectal asociada con el uso del sistema de manejo fecal. Todos los pacientes que mostraron una complicación rectal tenían comorbilidades subyacentes graves, incluidos dos pacientes en diálisis, un paciente con cirrosis y tres pacientes con antecedentes recientes de cirugía cardíaca emergente. En tres pacientes el sangrado se resolvió espontáneamente, mientras que los cinco pacientes restantes requirieron intervención: ligadura de sutura transanal (2), colocación de clip endoscópico (1), taponamiento rectal (1) y proctectomía en un paciente con antecedentes de radioterapia pélvica.LIMITACIONES:Diseño retrospectivo, institución única.CONCLUSIONES:Este es el estudio más grande hasta la fecha que evalúa las complicaciones rectales del uso del sistema de manejo fecal. Si bien las tasas de lesión rectal son bajas, pueden provocar una morbilidad grave. La edad avanzada, las comorbilidades graves, la radioterapia pélvica y el estado de anticoagulación o coagulopatía son factores importantes a considerar antes de la colocación del sistema de manejo fecal. Consulte Video Resumen en http://links.lww.com/DCR/B698.

Fuentes de energía en apendicectomía laparoscópica en un programa académico de Cirugía general en Colombia / Energy sources in laparoscopic appendectomy in an academic program of General Surgery in Colombia

Introducción. La apendicectomía por laparoscopia se considera el patrón de oro en el tratamiento de la apendicitis aguda. Sin embargo, su disponibilidad es limitada en nuestro sistema de salud, principalmente por los costos asociados. El objetivo de este estudio fue evaluar la relación entre el uso de los diferentes tipos de energía y los métodos de ligadura de la base apendicular, con las complicaciones postoperatorias, al igual que describir los costos asociados. Métodos. Estudio observacional analítico de una cohorte retrospectiva de pacientes mayores de 15 años a quienes se les realizó apendicectomía por laparoscopia, en un hospital universitario entre los años 2014 y 2018. Se utilizaron modelos de regresión logística y lineal para evaluar la relación entre métodos de ligadura del meso y base apendicular, desenlaces operatorios y costos. Resultados. Se realizaron 2074 apendicectomías por laparoscopia, 58,2 % (n=1207) en mujeres, la edad mediana fue de 32 años. En el 71,5 % (n=1483) la apendicitis aguda no fue complicada. La energía monopolar para la liga-dura del meso apendicular fue la utilizada más frecuentemente en 57,2 % (n=1187) y el Hemolok® el más utilizado para la ligadura de la base apendicular en el 84,8 % (n=1759) de los pacientes. No se observaron diferencias estadísticamente significativas en la tasa de infección del sitio operatorio, reintervención o íleo. El uso de energía simple redujo los costos del procedimiento de manera significativa durante el período evaluado. Discusión. El uso de energía monopolar demostró ser una técnica segura, reproducible y de menor costo en comparación con el uso de energía bipolar, independientemente de la fase de la apendicitis aguda. Lo anterior ha permitido que se realicen más apendicectomías por laparoscopia y que los médicos residentes de cirugía general puedan realizar procedimientos laparoscópicos de forma más temprana

Introduction. Laparoscopic appendectomy is considered the gold standard in the treatment of acute appendicitis. However, its availability is limited in our health system mainly due to the associated costs. The objective of this study is to evaluate the relationship between the use of different types of energy and the methods of ligation of the appendicular base with postoperative complications, as well as to describe the associated costs. Methods. Retrospective observational study of a cohort of patients older than 15 years old who underwent laparoscopic appendectomy in a university hospital between 2014 and 2018. Logistic and linear regression models were used to evaluate the relationship between methods of ligation of the meso and appendicular base, operative outcomes and costs. Results: 2074 laparoscopic appendectomies were performed. Of those, 58.2% (n=1207) were women, median age was 32 years. In 71.5% (n=1483), acute appendicitis was uncomplicated. Monopolar energy for ligation was the most frequently used for ligation of the appendicular meso in 57.2% (n=1187) and Hem-o-lok® the most used for ligation of the appendicular base in 84.8% (n=1759) of the patients. There were no statistically significant differences in the rate of surgical site infection, reoperation, or ileus. The use of simple energy reduced the costs of the procedure significantly during the study period. Discussion. The use of monopolar energy proved to be a safe, reproducible and a lower cost technique compared to the use of bipolar energy, regardless of the phase of acute appendicitis. This has allowed more laparoscopic appendectomies to be performed and the general surgery residents to perform laparoscopic procedures earlier

Adolescent Varicocelectomy: Success at What Cost? Clinical Outcome and Cost Comparison of Surgical Ligation and Percutaneous Embolization.

Objectives: Evaluate clinical outcome, recurrence, morbidity, and cost associated with laparoscopic surgical ligation versus percutaneous embolization of adolescent varicocele. We hypothesize that both approaches are similar in outcomes, complications, and cost. Materials and Methods: A retrospective review of 56 consecutive adolescent males, ≤18 years from 2006 to 2016 with clinical varicocele who underwent laparoscopic surgical ligation or percutaneous embolization. Patient demographics, operative time, postoperative complications, success, varicocele grade, recurrence, and hospital charges were abstracted. Results: Mean age was 14.2 ± 2.1 years; 48 (86%) patients having undergone laparoscopic surgical ligation and 8 (14%) percutaneous embolization. Intervention in 45 (80%) patients was for testicular hypotrophy (mean 27.4% ± 15.6%) and 11 (20%) for pain symptomology. Median follow-up was 17.5 months (range 1-65 months). After ligation, 2 (4%) patients developed hydroceles (1 with subsequent hydrocelectomy) and 6 (12%) varicocele recurrence. There were no cases of hydrocele or varicocele recurrence after percutaneous embolization. Twenty ligation patients had postoperative scrotal ultrasound demonstrating an increase in testicular volume by a reduction in difference in testicular volume from 27.3% ± 14.7% preoperatively to 11.2% ± 13.6% postoperatively (P < .001). There was significant difference in mean operative time between the groups (surgical ligation 41.3 minutes versus percutaneous embolization 117.9 minutes, P < .001) and hospital charges for the procedure (surgical ligation $3983 versus percutaneous embolization $18.165, P < .001). Conclusions: Contrary to our hypothesis, percutaneous embolization has seemingly lower rates of postoperative hydrocele and varicocele recurrence in comparison to surgical ligation but with three times the exposure to general anesthesia and at four times the price.

Expedient assessment of post-infarct remodeling by native cardiac magnetic resonance imaging in mice.

Novel therapeutic strategies aiming at improving the healing process after an acute myocardial infarction are currently under intense investigation. The mouse model plays a central role for deciphering the underlying mechanisms on a molecular and cellular level. Therefore, we intended to assess in-vivo post-infarct remodeling as comprehensively as possible using an expedient native magnetic resonance imaging (MRI) in the two most prominent infarct models, permanent ligation (PL) of the left anterior descending artery (LAD) versus ischemia reperfusion (I/R). Mice were subjected to either permanent or transient (45 min) occlusion of the LAD. After 3 weeks, examinations were performed with a 7-Tesla small animal MRI system. Data analysis was performed with the freely available software Segment. PL resulted in a massive dilation of the left ventricle, accompanied by hypertrophy of the non-infarcted myocardium and a decline of contractile function. These effects were less pronounced following I/R compared to healthy animals. Single plane assessments were not sufficient to capture the specific differences of left ventricular (LV) properties between the two infarct models. Bulls-eye plots were found to be an ideal tool for qualitative LV wall assessment, whereas a multi-slice sector-based analysis of wall regions is ideal to determine differences in hypertrophy, lateral wall thinning and wall thickening on a quantitative level. We combine the use of polar map-based analysis of LV wall properties with volumetric measurements using simple CINE CMR imaging. Our strategy represents a versatile and easily available tool for serial assessment of the LV during the remodeling process. Our study contributes to a better understanding of the effects of novel therapies targeting the healing of damaged myocardium.

Variations in utilization and clinical outcomes for endoscopic sphenopalatine artery ligation and endovascular arterial embolization in a single multi-hospital network.

PURPOSE: Endoscopic sphenopalatine artery ligation (ESPAL) and endovascular arterial embolization (EAE) are increasingly common treatment options for patients with refractory epistaxis. The objective of this study was to compare the utilization pattern and clinical outcomes between these interventions within our single multi-hospital network. MATERIALS AND METHODS: A retrospective study of all patients undergoing ESPAL and/or EAE within any of the hospitals in a single healthcare network between 2008 and 2017 was conducted. We compared differences in procedure utilization with various hospital characteristics. Secondarily, we evaluated clinical outcomes and costs associated with each procedure. RESULTS: Forty-three ESPAL and 33 EAE procedures were performed across 7 hospitals, with the majority of procedures being performed at teaching institutions (65% and 91%, p = .013). The majority of both interventions were performed in larger hospitals and EAE patients were more likely to undergo inter-hospital transfer compared to ESPAL patients (48.5% and 16.3%, p = .02). Success rates for ESPAL and EAE were comparable (95% and 93%); however, the median direct cost of treatment for EAE was significantly higher than the cost for ESPAL ($12984.89 and $5002.02, p < .0001). CONCLUSIONS: The majority of both ESPAL and EAE interventions were performed at teaching and larger hospitals. Transfers occurring prior to EAE may have been due to the limited availability of interventional radiology services, and likely contributed to the increased cost of treatment. ESPAL is a known cost-effective management strategy and should be considered early in treatment algorithms of refractory epistaxis.

Discrepancy between surgeon and radiological assessment of ligation level of the inferior mesenteric artery in patients operated for rectal cancer-impacting registry-based research and surgical practice.

BACKGROUND: The reliability of the registered ligation level of the inferior mesenteric artery (IMA) in the Swedish Colorectal Cancer Registry has been questioned. The primary aim of this study was to evaluate this parameter in the registry by comparing the registered ligation levels with a postoperative computed tomography angiography (CT-angiography) in patients operated for rectal cancer. METHODS: Patients operated for rectal cancer at two Swedish university hospitals were prospectively included between December 2016 and December 2019. At the 1-year postoperative follow-up, an additional CT-angiography was performed and independently examined by two radiologists. The radiological assessment of the ligation level was compared to registry data, using different measures of agreement. RESULTS: A total of 94 patients were included, 55 (59%) were men and 39 (41%) women. All patients underwent abdominal resection: conventional or robot-assisted laparoscopic surgery, n=56 (60%), or open resection, n=38 (40%). The ligation level as assessed on CT-angiography was high in 29 (31%) patients and low in 65 (69%). The registered level of ligation of the IMA and the radiological assessment of the CT-angiographies were consistent in 77/94 cases, demonstrating an 82% agreement and a sensitivity and specificity of 86% and 72%, respectively. The estimated Kappa value was 0.58, reaching 0.64 after prevalence bias adjustment. CONCLUSION: This study showed that CT-angiography can be used to evaluate the reliability of the registered ligation level in the Swedish Colorectal Cancer Registry. The demonstrated agreement between the registry and postoperative CT-angiography was moderate to good. This discrepancy impacts registry-based research using IMA ligation data and may ultimately influence surgical practice. TRIAL REGISTRATION: Clinical Trials identifier NCT03875612.

Assessment of peri-implant tissue dimensions following surgical therapy of advanced ligature-induced peri-implantitis defects.

BACKGROUND: To evaluate peri-implant tissue dimensions following implantoplasty and/or regenerative therapy of advanced ligature-induced peri-implantitis in dogs. MATERIAL AND METHODS: At all defect sites (n = 6 dogs, n = 48 implants), the intrabony component was filled with a particulate bovine-derived natural bone mineral (NBM). The supracrestal component was treated by either the application of an equine bone block (EB) or implantoplasty. In a split-mouth design, NBM and EB were soak-loaded with rhBMP-2 or sterile saline. All sites were covered using a native collagen membrane and left to heal in a submerged position for 12 weeks. The horizontal mucosal thickness (hMT) and bone thickness (hBT) were measured at four reference points: (v0) at the level of implant shoulder (IS), (v1) 50% of the distance IS-bone crest (BC), (v2) at the BC, and (v3) at the most coronal extension of the bone-to-implant contact. RESULTS: The general tendency indicated a gradual increase in hMT from the IS (v0) toward BC (v2), which was more pronounced at implant sites treated with the regenerative approach. The hBT values increased from v2 to v3, with the highest values at the v3 region measured for implant sites treated with adjunctive rhBMP-2. For sites treated with implantoplasty, the linear regression model demonstrated an inverse correlation between hMT and hBT, whereas a positive correlation was observed at those sites treated with the regenerative approach. CONCLUSION: Horizontal soft and hard tissue dimensions were similar among different treatment groups.

Assessment of soft and hard tissue dimensions following different treatment approaches of ligature-induced peri-implantitis defects.

OBJECTIVES: To evaluate peri-implant tissue dimensions following nonsurgical (NS) and surgical therapy (S) employing different decontamination protocols of advanced ligature-induced peri-implantitis in dogs. MATERIAL & METHODS: Peri-implantitis defects (n = 5 dogs, n = 30 implants) were randomly and equally allocated in a split-mouth design to NS or S treatment using either an Er:YAG laser (ERL), an ultrasonic device (VUS), or plastic curettes + local application of metronidazole gel (PCM), respectively. Horizontal bone thickness (hBT) and soft tissue thickness (hMT) were measured at different reference points: (v0) at the marginal portion of the peri-implant mucosa (PM); (v1) at 50% of the distance from PM to bone crest (BC); (v2) at the BC; (v3) at the most coronal extension of the bone-to-implant contact. Vertical peri-implant tissue height was calculated from PM to BC. RESULTS: All of the treatment groups showed a gradual hMT increase from v0 to the v2 reference point, followed by a reduction from v2 to the v3 region. The S-VUS subgroup tended to be associated with higher hMT values at the v0 region than the NS-VUS subgroup (0.44 mm versus 0.31 mm). PM-BC distance varied from 2.22 to 2.83 mm in the NS group, and from 2.07 to 2.38 in the S group. CONCLUSION: Vertical and horizontal peri-implant tissue dimensions were similar in different treatment groups.

A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

OBJECTIVE: To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. SUMMARY BACKGROUND DATA: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. METHODS: Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates. RESULTS: Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeon's preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon's preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and £2308 (s.d. £1228) for the surgeon's preference group (mean difference +£430, P=0.0174). The average total quality adjusted life years (QALYs) gained was marginally higher in the fistula plug group. The fistula plug was 35% to 45% likely to be cost-effective across a willingness to pay threshold of £20,000 to £30,000 / QALY. CONCLUSIONS: The Biodesign Surgisis anal fistula plug is associated with similar FIQoL and healing rates to surgeon's preference at 12 months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

Recorded Flexible Nasolaryngoscopy for Neonatal Vocal Cord Assessment in a Prospective Cohort.

OBJECTIVE: Assessing vocal cord mobility by flexible nasolaryngoscopy (FNL) can be difficult in neonates. To date, prospective studies evaluating the incidence and diagnostic accuracy of vocal cord paralysis (VCP) after surgical patent ductus arteriosus (PDA) ligation are limited. It is unknown whether video FNL improves diagnosis in this population. This study compared video recordings with bedside evaluation for diagnosis of VCP and determined inter-rater reliability of the diagnosis of VCP in preterm infants after PDA ligation. METHODS: Prospective cohort of preterm neonates undergoing bedside FNL within two weeks of extubation following PDA ligation. In a subset, FNL was recorded. Two pediatric otolaryngologists, blinded to the initial diagnosis, reviewed the FNL video recordings. RESULTS: Eighty infants were enrolled and 37 with a recorded FNL were included in the cohort. Average gestational age at birth was 25.2 weeks (SD: 1.2) and postmenstrual age at FNL was 37.0 weeks (SD: 4.5), which was 9.5 days (SD: 14.7) after extubation following PDA repair. There were 6 diagnosed with left VCP (16.2%; 95% CI: 4.3-28.1%) at bedside, and 9 diagnosed by video review (24.3%; 95% CI: 10.5-38.1%) (P = .56). Videos confirmed all 6 VCP diagnosed initially, but also identified 3 additional cases. Though imperfect, reviewing FNL by video showed substantial reliability (kappa = .75), with 91.9% agreement. CONCLUSION: Video recorded FNL most often confirms a bedside diagnosis of VCP, but may also identify discrepancies. Physicians should consider the limitations of diagnosis especially when infants persist with symptoms such as weak voice or signs of postoperative aspiration. LEVEL OF EVIDENCE: 2b.

[Analysis on clinical efficacy, safety and economy of Shaobei injection and elastic band ligation in the treatment of grade II or III hemorrhoids].

Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids. Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month. Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ(2)=0.035, P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. Conclusions: Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.