Reduction in lower urinary tract mucosal microtrauma as an effect of reducing eyelet sizes of intermittent urinary catheters.

Intermittent catheterization (IC) utilizing conventional eyelets catheters (CECs) for bladder drainage has long been the standard of care. However, when the tissue of the lower urinary tract comes in close proximity to the eyelets, mucosal suction often occurs, resulting in microtrauma. This study investigates the impact of replacing conventional eyelets with a drainage zone featuring multiple micro-holes, distributing pressure over a larger area. Lower pressures limit the suction of surrounding tissue into these micro-holes, significantly reducing tissue microtrauma. Using an ex vivo model replicating the intra-abdominal pressure conditions of the bladder, the intra-catheter pressure was measured during drainage. When mucosal suction occurred, intra-catheter images were recorded. Subsequently affected tissue samples were investigated histologically. The negative pressure peaks caused by mucosal suction were found to be very high for the CECs, leading to exfoliation of the bladder urothelium and breakage of the urothelial barrier. However, a micro-hole zone catheter (MHZC) with a multi-eyelet drainage zone showed significantly lower pressure peaks, with over 4 times lower peak intensity, thus inducing far less extensive microtraumas. Limiting or even eliminating mucosal suction and resulting tissue microtrauma may contribute to safer catheterizations in vivo and increased patient comfort and compliance.

Wound-healing properties of Stryphnodendron adstringens (barbatimão) in skin and mucosa injuries: a scoping review protocol.

OBJECTIVE: This review will map the literature on the types of research and methods used to investigate the wound-healing properties of Stryphnodendron adstringens ( barbatimão ) in skin and mucosa injuries. INTRODUCTION: Barbatimão is a Brazilian native plant and its wound-healing properties have been described in literature since the colonial period. It is one of the 71 plants included in the Brazilian health system's national list of medicinal plants of interest. However, existing literature reviews on the subject are limited, not comprehensive, lack a search strategy, and lack peer review. INCLUSION CRITERIA: This scoping review will include all types of published and unpublished sources that investigate the wound-healing properties of barbatimão to treat any type of skin or mucosa injury in humans, animals, or in vitro, in any context. METHODS: A scoping review will be conducted following JBI methodology. The main databases to be searched will include Embase (EBSCOhost), CINAHL (EBSCOhost), Scopus, PubMed (EBSCOhost), ScienceDirect, Lilacs, SciELO, CUIDEN, MOSAICO, Web of Science, Epistemonikos, and Google Scholar. Unpublished studies will also be considered. Two independent reviewers will examine titles and abstracts and select and read full-text sources for possible inclusion. Subsequently, the reviewers will extract and synthesize the data, which will be presented as a map, diagram, or table, according to the review objectives. REVIEW REGISTRATION: Open Science Framework osf.io/w57m4.

Accurate diagnosis of endoscopic mucosal healing in ulcerative colitis using deep learning and machine learning.

BACKGROUND: In clinical applications, mucosal healing is a therapeutic goal in patients with ulcerative colitis (UC). Endoscopic remission is associated with lower rates of colectomy, relapse, hospitalization, and colorectal cancer. Differentiation of mucosal inflammatory status depends on the experience and subjective judgments of clinical physicians. We developed a computer-aided diagnostic system using deep learning and machine learning (DLML-CAD) to accurately diagnose mucosal healing in UC patients. METHODS: We selected 856 endoscopic colon images from 54 UC patients (643 images with endoscopic score 0-1 and 213 with score 2-3) from the endoscopic image database at Tri-Service General Hospital, Taiwan. Endoscopic grading using the Mayo endoscopic subscore (MES 0-3) was performed by two reviewers. A pretrained neural network extracted image features, which were used to train three different classifiers-deep neural network (DNN), support vector machine (SVM), and k-nearest neighbor (k-NN) network. RESULTS: DNN classified MES 0 to 1, representing mucosal healing, vs MES 2 to 3 images with 93.8% accuracy (sensitivity 84.6%, specificity 96.9%); SVM had 94.1% accuracy (sensitivity 89.2%, specificity 95.8%); and k-NN had 93.4% accuracy (sensitivity 86.2%, specificity 95.8%). Combined, ensemble learning achieved 94.5% accuracy (sensitivity 89.2%, specificity 96.3%). The system further differentiated between MES 0, representing complete mucosal healing, and MES 1 images with 89.1% accuracy (sensitivity 82.3%, specificity 92.2%). CONCLUSION: Our DLML-CAD diagnosis achieved 94.5% accuracy for endoscopic mucosal healing and 89.0% accuracy for complete mucosal healing. This system can provide clinical physicians with an accurate auxiliary diagnosis in treating UC.

Vaginal laceration leading to air embolism during consensual sexual intercourse.

Vaginal injuries with clinical complications apart from local bleeding following sexual intercourse are thought to be rare events that have recently fostered a discussion on the topic. We report a case of a vaginal laceration resulting in death caused by air embolism in a non-pregnant woman during consensual sexual intercourse with digital and penile penetration. Hysterectomy and a preexisting vaginal injury were additional risk factors present in this case. Besides case history and autopsy findings, histological examination of the vaginal lesion and postmortem computer tomography (PMCT) helped in diagnosing the cause of death and underlying pathophysiological mechanisms.

Skin and Mucosal Damage in Patients Diagnosed With COVID-19: A Case Report.

Patients admitted to the intensive care unit (ICU) are at a high risk for developing pressure injuries. A patient requiring multiorgan support is at a higher risk for pressure injuries related to immobility, sedation, vasopressors, and hypoxia. To mitigate pressure injuries, our hospital utilizes a bundle approach to prevent skin injury. However, despite efforts to prevent pressure injuries, we found our patients in the ICU with the diagnosis of COVID-19 went on to develop significant pressure and mucosal injuries. This is a case report of 4 patients diagnosed with COVID-19 who developed significant skin and mucosal injuries during their ICU admissions in the month of March 2020. We found that patients developed skin conditions that were initially thought to be deep-tissue injuries (DTIs) early in the admission. The DTIs progressed over the course of the admission in the ICU and evolved to thick adherent eschar that appeared to be unstageable pressure injuries, which extended beyond the soft tissue directly over the bony prominence. We also found that skin damage to the mucosa of the nares, tongue, lips, and urethra presented first as inflammation and then progressed to thick eschar. Despite maximum pressure relief with the use of a pressure-relieving turn and position system, bordered foam dressings, fluidized positioners, specialty beds, and leadership support for twice-a-week skin checks, our patients diagnosed with COVID-19 developed extensive skin damage across the fleshy portion of the buttocks and on the mucosa of the nares, tongue, lips, and urethra during minimal exposure to pressure. Although the initial presentation of the skin damage appeared to be related to pressure, the extent of the skin damage suggests a vascular inflammatory process beyond skin damage related to pressure.

Desgarro perineal con mucosa vaginal íntegra tras primera relación sexual / Perineal tear with intact vaginal mucosa after first sexual intercourse

RESUMEN Las lesiones del tracto genital femenino tras relaciones sexuales son un problema frecuente en las urgencias de ginecología, pero poco estudiado salvo su aspecto médico-legal. Su incidencia es desconocida ya que muchas mujeres no llegan a consultar por miedo o pudor. El reconocimiento precoz de estas lesiones y su correcto tratamiento puede evitar la parición de secuelas que acompañarán a nuestra paciente durante el resto de su vida. Presentamos el caso de una paciente de 18 años con un desgarro perineal con mucosa vaginal íntegra tras su primera relación sexual.

ABSTRACT Injuries to the female genital tract after sexual intercourse are a frequent problem in gynecological emergencies, but little studied except for their medico-legal aspect. Its incidence is unknown since many women do not go to their specialist out of fear or embarrassment. Early recognition of these injuries and their correct treatment may prevent the appearance of sequelae that will accompany our patient for the rest of her life. We present the case of an 18-year-old patient with a perineal tear with intact vaginal mucosa after her first sexual intercourse.

Mucosal barrier injury-associated bloodstream infections in pediatric oncology patients.

BACKGROUND: Single-center reports of central line-associated bloodstream infection (CLABSI) and the subcategory of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) in pediatric hematology oncology transplant (PHO) patients have focused on the inpatient setting. Characterization of MBI-LCBI across PHO centers and management settings (inpatient and ambulatory) is urgently needed to inform surveillance and prevention strategies. METHODS: Prospectively collected data from August 1, 2013, to December 31, 2015, on CLABSI (including MBI-LCBI) from a US PHO multicenter quality improvement network database was analyzed. CDC National Healthcare Safety Network definitions were applied for inpatient events and adapted for ambulatory events. RESULTS: Thirty-five PHO centers reported 401 ambulatory and 416 inpatient MBI-LCBI events. Ambulatory and inpatient MBI-LCBI rates were 0.085 and 1.01 per 1000 line days, respectively. Fifty-three percent of inpatient CLABSIs were MBI-LCBIs versus 32% in the ambulatory setting (P  <  0.01). Neutropenia was the most common criterion defining MBI-LCBI in both settings, being present in ≥90% of events. The most common organisms isolated in MBI-LCBI events were Escherichia coli (in 28% of events), Klebsiella spp. (23%), and viridans streptococci (12%) in the ambulatory setting and viridans streptococci (in 29% of events), E. coli (14%), and Klebsiella spp. (14%) in the inpatient setting. CONCLUSION: In this largest study of PHO MBI-LCBI inpatient events and the first such study in the ambulatory setting, the burden of MBI-LCBI across the continuum of care of PHO patients was substantial. These data should raise awareness of MBI-LCBI among healthcare providers for PHO patients, help benchmarking across centers, and help inform prevention and treatment strategies.

Histopathologic Evaluation of the Effects of Intraurethral Platelet Rich Plasma in Urethral Trauma Experimentally Induced in Rat Model.

OBJECTIVE: To determine the efficacy of platelet rich plasma applied early initialization after urethral trauma for preventing inflammation and spongiofibrosis. MATERIALS AND METHODS: Twenty-three rats were randomized and divided into 3 groups, with 10 rats in 2 groups. Only sham group had 3 rats. The urethras of all rats were traumatized with a pediatric urethrotome knife at 6- and 12-o'clock. For 15 days, group I was given platelet rich plasma (PRP) once a day without urethral injury (sham group), group II (n = 10) was not given any medical treatment only urethral injury group (UI-PRP), group III (n = 10) was given PRP once a day intraurethrally as instillation using a 22 ga catheter sheath with urethral injury (UI+PRP). On day 15, the penises of the rats were degloved to perform penectomy. RESULTS: A significant difference was detected in all parameters when the sham, UI-PRP, UI+PRP groups were compared (respectively, P = .001, / <.001, / .008 / .007) and a significant difference was observed among mucosal inflammation, fibrosis, and edema parameters when UI-PRP and UI+PRP groups were compared. (Respectively; P <.001, / <.001 / .006). CONCLUSION: In this study, it was shown that intraurethral PRP applied after urethral trauma significantly decreased mucosal inflammation, spongiofibrosis, and edema. Depending on the results we acquired in this study, we think that PRP may be a promising option in urethral stricture treatment.

Prospective Initiative to Reduce Mucosal Barrier Injuries and Bloodstream Infections in Patients With Hematologic Malignancy Receiving Inpatient Chemotherapy.

PURPOSE: Mucosal barrier injury (MBI) occurs during periods of prolonged neutropenia in patients receiving cytotoxic chemotherapy for hematologic malignancies. This can lead to laboratory-confirmed bloodstream infections (LCBIs) and subsequent complications, including sepsis, organ failure, and possible death. There are no published prevention strategies for MBI. The purpose of our proposal was to decrease our MBI-LCBI events per month by 25%. METHODS: A multidisciplinary team was assembled to achieve this proposal. Cause-and-effect diagrams in addition to Pareto charts were used to investigate potential interventions. Using Plan-Do-Study-Act (PDSA) cycles, multiple tests of change were designed over the course of 3 years. RESULTS: The number of baseline events per month for MBI-LCBIs was 1.1. With the completion of the first PDSA cycle, the MBI-LCBI events dropped to 1.0 event per month. A second PDSA cycle involving implementation of an oral care kit improved to 0.35 events per month. This unfortunately was not sustained, and a root cause analysis demonstrated that physician noncompliance with ordering the oral kit was the main reason. After the change of a physician-driven protocol to a nurse-driven protocol, the third PDSA cycle resulted in a decrease in MBI-LCBI events to 0.89 events per month. CONCLUSION: To our knowledge, this is the first published report of an intervention to prevent MBI-LCBI events. Through a multidisciplinary approach and with quality improvement tools, we were able to demonstrate a significant reduction in MBI-LCBI events.

Incidence, Risk Factors, and Outcomes of Patients Who Develop Mucosal Barrier Injury-Laboratory Confirmed Bloodstream Infections in the First 100 Days After Allogeneic Hematopoietic Stem Cell Transplant.

Importance: Patients undergoing hematopoietic stem cell transplant (HSCT) are at risk for bloodstream infection (BSI) secondary to translocation of bacteria through the injured mucosa, termed mucosal barrier injury-laboratory confirmed bloodstream infection (MBI-LCBI), in addition to BSI secondary to indwelling catheters and infection at other sites (BSI-other). Objective: To determine the incidence, timing, risk factors, and outcomes of patients who develop MBI-LCBI in the first 100 days after HSCT. Design, Setting, and Participants: A case-cohort retrospective analysis was performed using data from the Center for International Blood and Marrow Transplant Research database on 16 875 consecutive pediatric and adult patients receiving a first allogeneic HSCT from January 1, 2009, to December 31, 2016. Patients were classified into 4 categories: MBI-LCBI (1481 [8.8%]), MBI-LCBI and BSI-other (698 [4.1%]), BSI-other only (2928 [17.4%]), and controls with no BSI (11 768 [69.7%]). Statistical analysis was performed from April 5 to July 17, 2018. Main Outcomes and Measures: Demographic characteristics and outcomes, including overall survival, chronic graft-vs-host disease, and transplant-related mortality (only for patients with malignant disease), were compared among groups. Results: Of the 16 875 patients in the study (9737 [57.7%] male; median [range] age, 47 [0.04-82] years) 13 686 (81.1%) underwent HSCT for a malignant neoplasm, and 3189 (18.9%) underwent HSCT for a nonmalignant condition. The cumulative incidence of MBI-LCBI was 13% (99% CI, 12%-13%) by day 100, and the cumulative incidence of BSI-other was 21% (99% CI, 21%-22%) by day 100. Median (range) time from transplant to first MBI-LCBI was 8 (<1 to 98) days vs 29 (<1 to 100) days for BSI-other. Multivariable analysis revealed an increased risk of MBI-LCBI with poor Karnofsky/Lansky performance status (hazard ratio [HR], 1.21 [99% CI, 1.04-1.41]), cord blood grafts (HR, 2.89 [99% CI, 1.97-4.24]), myeloablative conditioning (HR, 1.46 [99% CI, 1.19-1.78]), and posttransplant cyclophosphamide graft-vs-host disease prophylaxis (HR, 1.85 [99% CI, 1.38-2.48]). One-year mortality was significantly higher for patients with MBI-LCBI (HR, 1.81 [99% CI, 1.56-2.12]), BSI-other (HR, 1.81 [99% CI, 1.60-2.06]), and MBI-LCBI plus BSI-other (HR, 2.65 [99% CI, 2.17-3.24]) compared with controls. Infection was more commonly reported as a cause of death for patients with MBI-LCBI (139 of 740 [18.8%]), BSI (251 of 1537 [16.3%]), and MBI-LCBI plus BSI (94 of 435 [21.6%]) than for controls (566 of 4740 [11.9%]). Conclusions and Relevance: In this cohort study, MBI-LCBI, in addition to any BSIs, were associated with significant morbidity and mortality after HSCT. Further investigation into risk reduction should be a clinical and scientific priority in this patient population.

Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study.

Aspirin (acetylsalicylic acid, ASA) can lead to gastrointestinal mucosal injury through disruption of its protective phospholipid bilayer. A liquid formulation of a novel pharmaceutical lipid-aspirin complex (PL-ASA) was designed to prevent this disruption. We sought to determine the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of PL-ASA compared with immediate release aspirin (IR-ASA). In this active-control crossover study, 32 healthy volunteers were randomized to receive 1 of 2 dose levels (a single dose of 325 mg or 650 mg) of either PL-ASA or IR-ASA. After a 2-week washout period between treatment assignments, subjects received a single dose of the alternative treatment, at the same dose level. The primary objectives of the study were to assess, for PL-ASA and IR-ASA at 325 mg and 650 mg dose levels, PK and PD bioequivalence, and safety, over a 24-h period after administration of both drugs. PK parameters were similar for PL-ASA and IR-ASA, and met FDA-criteria for bioequivalence. Regarding PD, both drugs also showed Cmin TxB2 values below 3.1 ng/mL (cut-off associated with decreased cardiovascular events) and > 99% inhibition of serum TxB2 ( ≥ 95% inhibition represents the cut-off for aspirin responders) along with similar results in several secondary PK/PD parameters. There were no serious adverse events or changes from baseline in vital signs or laboratory values in either of the 2 treatment groups. PL-ASA's novel liquid formulation has similar PK and PD performance compared with IR-ASA, supporting functional and clinical equivalence. These data coupled with the improved gastric safety of PL-ASA suggest that this novel formulation may exhibit an improved benefit-risk profile, warranting evaluation in future trials.Clinical trial registration: http://www.clinicaltrials.gov . Unique Identifier: NCT04008979.

Effectiveness of Low-Level Laser Therapy with a 915 Nm Wavelength Diode Laser on the Healing of Intraoral Mucosal Wound: An Animal Study and a Double-Blind Randomized Clinical Trial.

Background and objectives: Diode laser has been the most popular low-level laser therapy (LLLT) technique in dentistry due to its good tissue penetration, lower financial costs, small size for portable application, and convenience to use. A series of recent studies with 940 nm or 980 nm lasers demonstrated that LLLT showed positive effects after third molar extraction or periodontal flap surgery. However, the effects of LLLT on intraoral mucosal wound healing after surgical incision have not yet been determined in human clinical study. Materials and Methods: The present study was performed to determine the efficacy and safety of 915 nm wavelength low-level laser therapy (LLLT) in mucosal wound healing. A total of 108 Sprague-Dawley rats were used. They were divided into three groups: Abrasive wound group, immediate LLLT once group, and daily LLLT group. As a clinical study, a total of 16 patients with split-mouth design subjected to bilateral mandibular third molar extraction were allocated into the LLLT group and placebo group. The process of LLLT was performed on postoperative days 0, 1, and 7, and parameters related to wound healing were analyzed on days 1, 7, and 14. Results: Repeated laser irradiation promoted mucosal wound healing of the rats. In the clinical study, although there were no significant statistical differences between the LLLT and placebo groups in all inflammatory parameters, the early stage mucosal healing tendency of wound dehiscence was higher in the LLLT group than in the placebo group clinically on postoperative day 1. Conclusions: The present results showed that 915 nm LLLT could be applied safely as an auxiliary therapy for mucosal wound healing.

Symptoms and Upper Gastrointestinal Mucosal Injury Associated with Bisphosphonate Therapy.

Objective The incidence of osteoporosis is increasing with the rapid aging of the Japanese population. Bisphosphonates are first-line agents used for the treatment of osteoporosis, but they can cause upper gastrointestinal mucosal injury. This study investigated symptoms and upper gastrointestinal mucosal injury associated with oral bisphosphonates. Methods Symptoms were evaluated using the F-scale questionnaire, and esophageal mucosal injury and gastroduodenal ulceration were assessed by endoscopy. Patients were stratified by the type of bisphosphonate (alendronate, risedronate, or minodronate), treatment schedule (once weekly or every four weeks), and the concomitant use of other medications [antithrombotic agents, nonsteroidal anti-inflammatory drugs (NSAIDs), or acid suppressants]. Patients The subjects included 221 patients treated with oral bisphosphonates for at least one month. Results The median F-scale total score was 4 (0-34), reflux score was 2 (0-20), and the mean dyspepsia score was 2 (0-16). Endoscopy showed esophageal mucosal injury of Grade A or worse (Los Angeles classification) in 22/221 patients (10.0%) and gastroduodenal ulcers in 9 patients (4.1%). The dyspepsia score in patients who took minodronate every four weeks was significantly lower (p<0.05) in comparison to patients who took other bisphosphonates. The dyspepsia score was significantly higher (p<0.05) and mucosal injury was significantly more frequent in patients who also used antithrombotic agents and NSAIDs. Conclusion Symptoms and upper gastrointestinal mucosal damage were not necessarily frequent or severe in patients treated with bisphosphonates. However, the concomitant use of bisphosphonates with antithrombotic agents and NSAIDs increased both symptoms and mucosal injury. The symptoms were milder in patients using minodronate once monthly.

The effects of different packing materials on healing and hearing after trauma to middle ear mucosa, an experimental study in rats.

PURPOSE: To compare the performance of Spongostan, Otopore, Spongostan soaked with dexamethasone and Spongostan soaked with Hyaluronic acid (HA) as middle ear packing material after mucosal trauma. METHODS: Twenty rats were divided into 4 groups. In control group (group 1), the middle ear cavities of animals were bilaterally packed with Spongostan; in group 2, with Otopore; in group 3, with Spongostan soaked with dexamethasone; and in group 4, with Spongostan soaked with HA. Auditory brainstem responses (ABRs) were performed preoperatively and 1 and 6 weeks postoperatively. Histological analyses were performed to evaluate the inflammatory reaction and wound healing in the middle ear cavity. RESULTS: ABR recordings demonstrate that threshold level changes from baseline were minor in Otopore and Spongostan soaked with dexamethasone packed ears. Threshold levels were higher in the Spongostan and Spongostan soaked with HA packed ears compared with both Otopore and Spongostan soaked with dexamethasone packed ears. Histological analyses showed that Spongostan caused inflammation more intense than Otopore and Spongostan soaked with dexamethasone. Residual material at postoperative week 6, new bone formation and adhesion were common in the Spongostan group compared with other groups. Fibrosis was more common in Spongostan group compared with other groups but the difference was not significant. CONCLUSION: Otopore appears to be safe and effective for use in otologic surgery. The inflammation, adhesion and new bone formation decreased when Spongostan was used with steroid or HA, when compared to Spongostan alone.

Urolithiasis and intracorporeal lithotripsy in 37 Military Hospital, Accra, Ghana.

OBJECTIVE: The purpose of this study was to determine the indications and complications of intracorporeal lithotripsy in our institution. METHODS: Retrospective study carried out at the urology unit of the 37 Military Hospital between 2012-2015. 42 patients had intracorporeal lithotripsy out of 359 patients who had surgery within the period. Records of all patients who had intracorporeal lithotripsy between December 2012 to December 2015 were collected and analysed. An endourology log sheet was used to record data of patient's name, age, sex, indication for operation, location of stone, intraoperative complications, type of instruments/materials used, stone analysis and follow-up dates. All patients between the ages of six months to seventy years presenting with urinary stones diseases within the period were included, whilst patients with urinary stone disease who were managed with open surgery were excluded.Ethical clearance was obtained from the 37 Military Hospital institutional review board. RESULTS: Lithotripsy constituted 42/359(11.7%) of the methods used in the surgical cases done within the period.The commonest age of presentation was between 31-40 years (26.2%), with a male to female ratio of 2:1. The commonest indications for lithotripsy were pain (92.8%) and hydronephrosis (61.9%). Ureteric stones are more common (50%), followed by renal stones (45%) with the commonest site being the proximal ureter. The commonest procedure was ureteroscopy. Ureteral mucosal injury (5/43) (11.62%), was the commonest intraoperative complication. Postoperative complications were reno-cutaneous fistula (1/43) (2.32%), severe bleeding (1/43) (2.32%) haematuria (4/43) (9.30%). CONCLUSION: Pain was the commonest indication for intra-corporeal lithotripsy (92.8%) and also the commonest post-operative complication (9.30%). FUNDING: None declared.

Endoscopic dilatation improves long-term dysphagia following head and neck cancer therapies: a randomized control trial.

Long-term pharyngeal dysphagia is a common complication following head and neck cancer (HNC) therapies. High-level evidence for pharyngoesophageal junction (POJ) dilatation as a treatment in this population is lacking. We aimed to evaluate the safety and efficacy of POJ dilatation in dysphagic HNC survivors. This single-center, single-blind, placebo-controlled trial (St George Hospital, Sydney, Australia) randomly assigned (1:1) HNC survivors with long-term dysphagia (≥12 months postcompleted HNC therapies) to receive either graded endoscopic dilatations or sham dilatation (placebo). Patients were blinded to intervention types. Two strata were used for permuted randomization: (1) HNC therapies (total laryngectomy vs. chemoradiation alone); (2) Prior POJ dilatation (nil vs. previous dilatation). The primary endpoint was a short-term clinical response in swallowing function (3 months), defined as (1) a decrease in Sydney Swallow Questionnaire score by ≥200 or a score ≤ ULN; and (2) satisfactory global clinical assessment. The secondary endpoints were dysphagia relapse and serious adverse events. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000707369). Between 13 January 2013 and 16 January 2017, 41 patients were randomly assigned to endoscopic dilatation (n = 21) or placebo (n = 20). The short-term response rate in the endoscopic dilatation group was 76% (n = 16), compared with 5% (n = 1) in the placebo group (P < 0.001). There were no serious adverse events. The finding of a mucosal tear postdilatation was associated strongly with clinical response (OR 13.4, 95% CI [2.4, 74.9], P = 0.003). Kaplan-Meier estimate of dysphagia relapse is 50% by 9.6 months (95% CI [6.0, 19.2]) from completion of dilatation. Endoscopic dilatation of the POJ is a safe and efficacious therapy for the treatment of long-term dysphagia in HNC survivors. Close follow-up and repeat dilatation are necessary given the high dysphagia relapse rate.

Patient with mediastinitis caused by delayed mucosal damage after peroral endoscopic myotomy.

Peroral endoscopic myotomy (POEM) is a groundbreaking procedure for treating esophageal achalasia, and many reports from various facilities have described its safety and efficacy. However, there have been few reports on adverse events. Here, we report a case of a patient with mediastinitis caused by delayed mucosal damage after POEM. This case was the most severe among all POEM cases at our hospital. A 58-year-old man had experienced dysphagia and chest tightness since he was around 50 years old. At a previous hospital, he had been diagnosed with nonerosive reflux disease and had undergone fundoplication. As his symptoms did not improve, he was referred to our department. POEM was able to be finished but a stable visual field could not be maintained throughout procedure because of strong esophageal contractions. From findings of endoscopy and esophagography after POEM, the patient was diagnosed mediastinitis caused by delayed esophageal perforation. In this case, conservative treatment (fasting, antibiotic therapy, and enteral feeding) was successful. However, the option to administer surgical treatment, such as drainage, must not be overlooked.