Injection of sodium hypochlorite into soft tissues of the oral cavity: A literature review with clinical preventive recommendations.

Injection of sodium hypochlorite (NaOCl) solution instead of local anaesthetic (LA) solution is an iatrogenic error with serious consequences including medico-legal implications. Such cases have been reported despite recommended precautionary measures. The purpose of this article is to review the literature on such cases and present clinical preventive recommendations. Electronic search was conducted in PubMed/Medline, Google Scholar, Cochrane, Scopus, Lilacs, ScienceDirect, and Crossref databases for articles reporting accidental or mistaken or inadvertent injection of NaOCl instead of LA during dental or endodontic treatment. Articles reporting NaOCl accident due to extrusion or injection of NaOCl beyond root confines were excluded. A total of 11 articles were found and reviewed. Data pertaining to the patient, injected NaOCl, cause, clinical manifestations, management, hospitalization, healing and recovery, and long-term or residual effects were extracted, compiled, and analysed for interpretation and discussion. Injection of NaOCl instead of LA into the soft tissues leads to varying clinical manifestations with unpredictable extent, outcome, and recovery period. The onus lies with the clinician to prevent it. Therefore, a clinician must take all the precautionary measures and confirm the identity of LA and NaOCl solutions before delivering them. The presented clinical recommendations assist clinicians to prevent it, including its potential medico-legal consequences. However, in case of such an unfortunate event, it is crucial to immediately identify and quickly manage it to limit the tissue damage or complications.

The Use of Botulinum Toxin in Raynaud Phenomenon: A Comprehensive Literature Review.

BACKGROUND: Raynaud phenomenon (RP) is a vasospastic condition of the digits that can be primary or secondary to systemic disease. Symptoms are triggered by cold or stress and can cause pain and skin color changes. The chronic ischemia may lead to necrosis, ulceration, and amputation. There are no Food and Drug Administration-approved treatments and cases refractory to pharmacologic and surgical treatments are difficult to control. Local botulinum toxin injections have been increasingly used in the treatment of Raynaud disease and have shown promising results. AIM OF THE STUDY: To examine the outcomes, techniques, and complications of botulinum toxin use for the treatment of Raynaud disease. METHODS: The PubMed database was queried using "botulinum toxin" AND "Raynaud phenomenon" as title key words. Preferred reporting items for systematic reviews and meta-analysis criteria were used. Additional articles were selected while reviewing the references of the articles from PubMed. No time restrictions were followed. Articles of all languages were included. Articles were analyzed for study type, demographics, diagnosis/inclusion criteria, treatment methods, outcome measures, length of follow-up, results, and complications. A positive outcome was defined as subjective improvement in symptoms and/or improvement in the outcome measures. A poor outcome was defined as harm done to the patient by the injection that would not have occurred otherwise. RESULTS: Forty-two clinical studies describing the use of botulinum toxin for Raynaud's phenomenon were found. A total of 425 patients with primary or secondary Raynaud's were treated, with ages ranging from 14 to 91 years. There were 342 women and 81 men, with a female-to-male ratio of 38:9. Outcomes were positive in 96.2% of patients. There were 14.2% of the studies that reported 3.5% of all patients showing no subjective improvement. A single study reported a poor outcome for 1 patient. There were 40.5% of the studies that reported complications, affecting 20.2% of all patients. The most frequently reported complication was transient hand weakness, affecting 44.2% of patients with complications and 8.9% of total patients. Weakness resolved in hours to months after injection. Pain at the injection site lasting minutes to days was reported in 40.7% of patients with complications, and 8.2% of total patients. CONCLUSIONS: Botulinum toxin treatment for RP is effective. Complications are minor and self-limiting.

Four-Point Injection Technique of Polyacrylate/Polyalcohol Copolymer in Vesicoureteral Reflux After KidneyTransplant.

OBJECTIVES: Vesicoureteral reflux after kidney transplant is mostly asymptomatic, but recurrent urinary tract infections can cause graft rejection. Although the gold standard treatment is open surgical repair, we believe that endoscopic treatment can be further improved. Here, we investigated the long-term outcomes of 4-point endoscopic injection of polyacrylate/polyalcohol copolymer in patients with vesicoureteral reflux after kidney transplant. MATERIALS AND METHODS: Patients who had undergone 4-point endoscopic injectionofpolyacrylate/polyalcohol copolymer for symptomatic vesicoureteral reflux after kidney transplant and were followed for atleast 3 years were included. Patients with dysfunctional and/or obstructive voiding patterns, unsuccessful primary endoscopic treatment, concomitant injection of native kidney reflux, and incomplete follow-up were excluded. We evaluated patient characteristics, perioperative data, and clinical and radiological outcomes. Urine culture, serum creatinine, and renal ultrasonography were assessed every 3 months. Voiding cystourethrography was performed at month 3 and when recurrence was suspected. Clinical success was defined as absence of febrile urinary tract infection during follow-up, and radiological success was defined as absence of vesicoureteral reflux in the voiding cystourethrography. RESULTS: Of 21 study patients, 14 (66.6%) were female and 7 (33.3%) were male patients. Average age was 37.1 years (range, 12-62 years). According to preoperative voiding cystourethrography, 3 patients (14.2%) had grade II, 13 patients (61.9%) had grade III, and 5 patients (23.8%) had grade IV vesicoureteral reflux. Eighteen patients (85.7%) had clinical success with the first injection, and 20 patients (95.2%) had success with the second injection. Eleven patients (52.3%) demonstrated radiological success. The reflux degree of all patients, except 2, had partially or completely regressed. Ureteral balloon dilatation and double J stent implantation was performed in 1 patient (4.7%) due to ureteral obstruction. CONCLUSIONS: The 4-point injection of polyacrylate/- polyalcohol copolymer provided long-term permanent success for symptomatic vesicoureteral reflux after kidney transplant.

[Insulin-derived amyloidosis (insulin ball) and skin-related complications of insulin therapy].

Skin-related complications of insulin therapy have long been a problem as a factor interfering with insulin therapy. Among the traditional skin-related complications, lipoatrophy and insulin allergy have decreased markedly with the development of insulin preparations, but lipohypertrophy is still common in insulin-treated patients. Recently, there have been more reports of a skin-related complication called insulin-derived amyloidosis or insulin ball. Insulin-derived amyloidosis is a condition in which injected insulin becomes amyloid protein and is deposited at the injection site. Insulin-derived amyloidosis causes poor glycemic control and increased insulin dose requirements, which are caused by decreased insulin absorption. Lipohypertrophy also decreases insulin absorption, but insulin-derived amyloidosis causes a more significant decrease in insulin absorption and has a greater clinical impact. Therefore, it is important to make a differential diagnosis between insulin-derived amyloidosis and lipohypertrophy, but sometimes it is difficult to distinguish the two and imaging studies are required. The diagnosis of insulin-derived amyloidosis is often difficult in the general practice, and its pathogenesis and prevalence have not been fully clarified. Recently, it has been reported that insulin-derived amyloidosis can be toxic, suggesting an association with minocycline use. The treatment of insulin-derived amyloidosis and lipohypertrophy is to avoid the site of amyloidosis or lipohypertrophy and inject insulin, but the dose of insulin injection should be reduced. Prevention of both insulin-derived amyloidosis and lipohypertrophy is important, and for this purpose, observations of the insulin injection site and instruction on appropriate insulin injection techniques are necessary, and multidisciplinary cooperation is extremely important.

Death from Pulmonary Embolism Caused by Vaginal Injection of Hyaluronic Acid: a Case Report and a Literature Review.

A 40-year-old woman underwent vaginoplasty with intramural injection of fillers from an illegal medical practitioner. Approximately 2 h after the injection, she developed lower abdominal pain. The patient was taken to the hospital approximately 5 h later due to worsening pain. When the patient was admitted for physical examination, she suddenly experienced cardiac and respiratory arrest. She was resuscitated but remained in a coma. Unfortunately, the patient died approximately 12 h after being admitted to the hospital. The forensic autopsy revealed extensive amorphous basophilic emboli in the small interstitial vascular lumen of both lungs, and a large amount of the same type of substances were also found in the vaginal wall. Hyaluronidase digestion and Alcian blue staining confirmed that most components of the injection were hyaluronic acid (HA). HA is widely used as a cosmetic filler in the field of plastic surgery and is generally considered to have few adverse effects. This paper reports the first anatomical case of fatal pulmonary embolism caused by vaginal injection of HA. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

PRESTO 2: An International Survey to Evaluate Patients' Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly.

INTRODUCTION: Real-world data evaluating patients' injection experiences using the latest devices/formulations of the long-acting (LA) somatostatin analogs (SSAs) lanreotide Autogel/Depot (LAN; Somatuline®) and octreotide LA release (OCT; Sandostatin®) are limited. METHODS: PRESTO 2 was a 2020/2021 e-survey comparing injection experience of adults with neuroendocrine tumors (NETs) or acromegaly treated with LAN prefilled syringe versus OCT syringe for > 3 months in Canada, Ireland, the UK and the USA (planned sample size, 304). PRIMARY ENDPOINT: the proportion of patients with injection-site pain lasting > 2 days after their most recent injection, analyzed using a multivariate logistic regression model. Secondary endpoints included interference with daily life due to injection-site pain and technical injection problems in patients with current SSA use for ≥ 6 months. RESULTS: There were 304 respondents (acromegaly, n = 85; NETs, n = 219; LAN, n = 168; OCT, n = 136; 69.2% female; mean age, 59.6 years). Fewer patients had injection-site pain lasting > 2 days after the most recent injection with LAN (6.0%) than OCT (22.8%); the odds of pain lasting > 2 days were significantly lower for LAN than OCT, adjusted for disease subgroup and occurrence of injection-site reactions (odds ratio [95% confidence interval]: 0.13 [0.06-0.30]; p < 0.0001). Injection-site pain interfered with daily life "a little bit" or "quite a bit" in 37.2% and 3.8% (LAN) versus 52.5% and 7.5% (OCT) of patients, respectively. Among patients with ≥ 6 months' experience with current SSA (92.4% of patients), technical injection problems never occurred in 76.8% (LAN) and 42.9% (OCT) of patients. CONCLUSIONS: Compared with OCT, significantly fewer patients using LAN had injection-site pain lasting > 2 days after their most recent injection. Also, fewer LAN-treated patients experienced technical problems during injection. These findings demonstrate the importance of injection modality for overall LA SSA injection experience for patients with acromegaly or NETs.

Patients with neuroendocrine tumors or acromegaly often receive long-term monthly treatment with somatostatin analogs. These injectable drugs stop the body from making an excess of certain hormones. Understanding patients' experiences of these injections helps to provide better care. The PRESTO 2 online study surveyed 304 patients in Canada, Ireland, the UK and the USA with neuroendocrine tumors or acromegaly who were being treated with a somatostatin analog, either lanreotide Autogel/Depot (LAN) or octreotide long-acting release (OCT). The survey asked about injection experience, including injection-site pain lasting > 2 days and how it affected patients' lives, anxiety before injections and technical problems during injections (like syringe blockages). The survey showed fewer patients receiving LAN than OCT had injection-site pain that lasted > 2 days, and fewer said that the pain interfered with their daily lives. There were fewer technical injection problems with LAN than with OCT. However, more patients receiving LAN than OCT felt anxious before their injection. In some countries (including Canada, Ireland and the UK, but not the USA), the patient (or family member/friend) can inject LAN if they are on a stable dose, their doctor agrees, and they received training. A nurse/doctor must inject OCT. In PRESTO 2, about 40% of non-US patients who were eligible injected themselves (or were helped by a family member/friend). This may explain why more patients reported anxiety in the LAN group. PRESTO 2 provides important insights into patients' experiences of receiving somatostatin analogs and helps identify areas for improving patient care.

When Is It Safe to Operate After Therapeutic Carpal Tunnel Injections?

BACKGROUND: Recent studies suggest increased complications when surgery closely follows corticosteroid injection. The purpose of this study was to understand the occurrence of surgical site infection (SSI), wound complications, and reoperation rates after carpal tunnel release (CTR) when corticosteroid injections were given within 180 days preoperatively. METHODS: Data were collected from the Truven MarketScan database from 2009 to 2018. Cohorts were created based on preoperative timing of injection (<30, 30-60, 61-90, 91-180 days) and number of injections (0, 1, 2, 3+). Logistic regression was performed to assess the contribution of preoperative injections on 90-day surgical site complications and 1-year reoperation while controlling for demographics and comorbidities. RESULTS: Overall, 223 899 patients underwent CTR. Of these, 17 391 (7.76%) had a preoperative injection in the 180 days preceding surgery. Univariate analysis demonstrated a relationship between timing of injections and noninfectious wound complications (P = .006) and rate of 1-year reoperation (P = .045). Univariate analysis demonstrated a relationship between number of injections and 1-year reoperation (P < .001). On multivariate analysis, those receiving injections within 30 days preoperatively had increased rates of SSI (P = .034) and noninfectious wound complications (P = .006) compared with those with no injection or at other time points. Patients with 2 (P = .002) or 3 or more injections (P < .001) in the 180-day preoperative period had increased odds of 1-year reoperation. CONCLUSION: Our study suggests increased risk of SSI, wound complications, and 1-year reoperation when corticosteroid injections are administered in the 30-day preoperative period. In addition, multiple steroid injections may increase the risk of 1-year reoperation.

Safety of Botulinum Toxin A Injections for Facial Rejuvenation: A Meta-Analysis of 9,669 Patients.

PURPOSE: To quantitatively evaluate safety profile for botulinum toxin A (BTX-A) injections among patients undergoing treatment for cosmetic indications is produced, with special attention to clinically relevant covariates and their relative impact on safety. METHODS: A systematic literature search was performed using PubMed (1996-January 2020) and Embase (1947-January 2020) to identify all randomized controlled trials (RCTs) that reported safety data for patients receiving BTX-A for cosmetic indications compared to placebo. A meta-analysis was performed to determine pooled risk ratios (RR) for treatment-related adverse events (TRAEs) and for specific adverse events. Meta-regression and additional analyses were performed for significant and/or clinically relevant covariates. RESULTS: Following the review of 8,690 studies, 32 RCTs involving 9,669 patients were included. The pooled RR of any TRAE occurring after BTX-A injection compared to placebo injection was 1.53 (95% CI, 1.33-1.77; p < 0.001). Statistically significant covariates included individual injection volume and total injection volume. The type of BTX-A formulation, treatment site, total BTX-A units, and BTX-A units per injection were not significant. Specific adverse events more likely to occur following BTX-A injection rather than placebo injection included eyelid/eyebrow malposition (RR 3.55; p < 0.001), facial paresis (RR 2.42; p = 0.316), and headache (RR 1.45; p = 0.003). Injection site reactions and injection site bruising occurred at similar rates in both groups. CONCLUSIONS: The overall safety profile of BTX-A is acceptable and consistent with previous publications. The authors' additional analyses provide a relative comparison of the impact of various treatment parameters on safety.

Inflammatory immune-mediated adverse reactions induced by COVID-19 vaccines in previously injected patients with soft tissue fillers: A case series of 20 patients.

BACKGROUND: Adverse events (AE) after COVID-19 vaccines, particularly, but not solely, with those messenger RNA (mRNA)-based vaccines, have rarely been reported in patients previously treated with dermal fillers (DF). OBJECTIVE: To evaluate the morphology, clinical characteristics, the timing of presentation, and outcomes of inflammatory AE appeared in patients injected with DF, after anti-COVID-19 vaccination. METHODS: Descriptive study of a case series of 20 consecutive patients collected after the occurrence of AE in previously filled areas post COVID-19 vaccination. RESULTS: From January 2021 to July 2021, we analyzed 20 AE reactions triggered by COVID-19 vaccines in the previously mentioned cohort. They were vaccinated with Pfizer/Biontech (11; 55%), Moderna (5; 25%), Astra-Zeneca (3; 15%), and Sputnik (1; 5%). The most common manifestations were oedema/swelling, angioedema, erythema, skin induration, and granuloma. Less common reactions included myalgia and lymphadenopathy. In 13/20 (65%) cases, the AE appeared after the first dose of vaccine. These inflammatory AE appeared more rapidly after the second dose than after the first one. In 13/20 (65%) cases, the symptomatology subsided with anti-inflammatory/antihistaminic drugs, while spontaneously in 3/20 (15%). The manifestations are ongoing.in the remaining four cases (20%). CONCLUSION: Although probably rare, both RNA-based and adenovirus-based anti-COVID-19 vaccines can cause inflammatory bouts in patients previously treated with DF. In these cases, caution should be paid on subsequent vaccine doses, considering a tailored risk/benefit for any case before next vaccination.

Painful Purulent Nodules Caused by Mycobacterium at Site of Lipodissolve Injections.

ABSTRACT: "Lipodissolve" (LD) is a non-FDA-approved solution of phosphatidylcholine in deoxycholate that was developed around 2004. A study of its safety reported minor and uncommon side effects including pain, tender nodules, pigmentary alterations, and ulceration at the site of injection. We present a 53-year-old woman who received LD injections bilaterally to her proximal arms. One week later, she developed painful nodules at each injection site. She was treated with a 10-day course of trimethoprim/sulfamethoxazole without improvement. An incisional biopsy was performed and showed deep dermal suppurative inflammation with numerous neutrophils and granulomas. Stains for bacteria, fungus, and acid-fast organisms were negative. Cultures for acid-fast bacilli grew Mycobacterium abscessus, sensitive to amikacin and clarithromycin. The patient was subsequently treated with intravenous amikacin, azithromycin, and bedaquiline with symptom resolution. Investigation revealed 3 similar infections linked to LD injections originating from the same physician's office. The most common organism implicated in injection infections is Staphylococcus aureus. Infections at injection sites caused by atypical mycobacteria have been reported to occur after tattooing, other types of injections, and implants. Of atypical mycobacteria, M. abscessus accounts for the greatest number of postinjection or iatrogenic infections. Common antitubercular drugs are not effective for treating atypical mycobacteria, making species identification and sensitivity testing imperative for treatment. This case highlights an unusual infection caused by cosmetic injections of LD, previously reported to be associated with minimal side effects, and the importance of examination for acid-fast bacilli and follow-up with culture, even in the absence of organisms identified on stained sections.

Clinical Management of Complications Following Filler Injection.

AIM: Dermal fillers have been progressively used for cosmetic procedures. Concurrently, the rates of filler complications have also increased. The aim of this study is to describe the clinical management and treatment we performed in patients with complications occurred after filler injection. METHODS: From March 2000 to February 2020, 197 patients have been evaluated for complications due to filler injection. For each patient type of material, symptoms and signs were recorded. Ultrasound evaluation was used to obtain information about the type, amount and location of the injected material. Magnetic Resonance Imaging was performed in those patients who were candidate for surgery. Based on the clinical manifestations, we performed a targeted therapy. RESULTS: The local and systemic medical therapy allowed us a complete remission of the clinical signs and symptoms in all patients presented with edema and erythema. We obtained optimal results with surgery, where a complete removal of the injected material was possible. In all the cases in which the complete removal of the infiltrated area could have led to functional impairments, we performed partial removal with poor outcomes. CONCLUSION: We observed complex clinical manifestations in the patients subjected to permanent fillers. An accurate knowledge upon the effects of the materials on tissues, a specific instrumental evaluation and a targeted therapy are crucial. We suggest the use of absorbable fillers. Patient should be subjected to filler implant in authorized structures by an expert specialist with experience in filler injection and with a thorough knowledge of the anatomical structures. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Stability indicating Rp-UPLC method development and validation for the simultaneous estimation of fosnetupitant and palonosetron in bulk and injection dosage form

Abstract A stability indicating UPLC method has been developed and validated for the simultaneous determination of fosnetupitant and palonosetron in bulk and in injection dosage form. This combination is used for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy for cancer. The chromatographic analysis was performed on an HSS, RP C18 column (2.1 x 100 mm, 1.8 µm) with an isocratic mobile phase composed of 0.25 M potassium dihydrogen orthophosphate buffer (pH 6.5), pH adjusted with dilute sodium hydroxide:acetonitrile (55:45 v/v), at a flow rate of 0.5 mL/min, and the eluents were monitored at an isosbestic point of 286 nm. The developed method was validated according to the ICH guidelines pertaining to specificity, precision, accuracy, linearity and robustness, and the stability indicating nature of the method was established by forced degradation studies. The retention times of fosnetupitant and palonosetron were observed at 1.390 and 2.404 min, respectively. The developed method proved to be accurate and precise. Linearity was established between 4.70 and 14.10 µg/mL for fosnetupitant and between 0.05 and 0.15 µg/mL for palonosetron. The LOD and LOQ were 0.115 and 0.385 µg/mL, respectively, for fosnetupitant, and 0.005 and 0.016 µg/mL, respectively, for palonosetron. Therefore, the proposed UPLC method was reliable, reproducible, precise and sensitive for the quantification of fosnetupitant and palonosetron.

Techniques to Relieve Pain Associated With Botulinum Injections for Palmar and Plantar Hyperhidrosis.

BACKGROUND: Palmar and plantar hyperhidrosis (HH) is a common condition characterized by excessive sweating of the palms and soles. Botulinum neurotoxin (BTX) is a very effective and safe treatment. However, the associated intense injection pain is a major limiting factor deterring patients from selecting this treatment. OBJECTIVE: The aim of this study was to review the numerous techniques used to minimize pain accompanying injections for palmoplantar HH. Additionally, the advantages and limitations of each modality will be discussed. MATERIALS AND METHODS: The authors performed a comprehensive literature search in PubMed/MEDLINE, Embase, Cochrane Central, and Google Scholar on randomized controlled trials, cohort studies, and case series on techniques to relieve pain of BTX injections for treatment of palmar and plantar HH. RESULTS: Current available techniques in reducing botulinum injection with merits and drawbacks are nerve blocks, Bier blocks, cryoanalgesia, needle-free anesthesia, topical anesthetics, and vibration anesthesia. CONCLUSION: Topical anesthesia, ice, and vibration are the safest and most convenient noninvasive available methods to relieve pain associated with botulinum injection. Nerve blocks, Bier block, and needle-free anesthesia provide better anesthesia but are limited by the need for training and equipment.

Diagnostic accuracy of optical coherence tomography for surgical margin assessment of feline injection-site sarcoma.

The invasive, locally aggressive nature of feline injection-site sarcomas (FISSs) poses a unique challenge for surgeons to obtain complete margins with surgical excision. Optical coherence tomography (OCT), an imaging technology that uses light waves to generate real-time views of tissue architecture, provides an emerging solution to this dilemma by allowing fast, high-resolution scanning of surgical margins. The purpose of this study was to use OCT to assess surgical margins of FISS and to evaluate the diagnostic accuracy of OCT for detecting residual cancer using six evaluators of varying experience. Five FISSs were imaged with OCT to create a training set of OCT images that were compared with histopathology. Next, 25 FISSs were imaged with OCT prior to histopathology. Six evaluators of varying experience participated in a training session on OCT imaging after which each of the evaluators was given a dataset that included OCT images and videos to score on a scale from cancerous to non-cancerous. Diagnostic accuracy statistics were calculated. The overall sensitivity and specificity for classification of OCT images by evaluators were 78.9% and 77.6%, respectively. Correct classification rate of OCT images was associated with experience, while individual sensitivities and specificities had more variation between experience groups. This study demonstrates the ability of evaluators to correctly classify OCT images with overall low levels of experience and training and also illustrates areas where increased training can improve accuracy of evaluators in interpretation of OCT surgical margin images.

Comparison of Subureteral Endoscopic Injection of Dextranomer/Hyaluronic Acid and Lich-Gregoir Ureteral Reimplantation in the Treatment of Pediatric Primary Vesicoureteral Reflux: A Prospective Randomized Study.

Background: The gold standard of surgical intervention of vesicoureteral reflux (VUR) is open ureteral reimplantation with high success and low complication rates. However, in recent years, endoscopic injection, dextranomer/hyaluronic acid (Dx/HA), has become an effective therapy for VUR. It is noted that limited prospective randomized trials compare the different surgical techniques of especially endoscopic injection versus open procedures. We aimed to compare the outcomes of endoscopic injection of Dx/HA and Lich-Gregoir open technique of ureteral reimplantation for grades III and IV primary VUR in pediatric patients. Materials and Methods: Between January 2016 and December 2018, 60 pediatric patients with grades III and IV primary VUR were included in a prospective randomized trial. Thirty cases with 45 refluxing ureters managed by endoscopic injection of Dx/HA comprised group A. Open Lich-Gregoir technique used in the other 30 cases with 48 refluxing ureters composed of group B. Renal ultrasound, voiding cystourethrography, and renal scintigraphy were used for follow-up. The surgical success rate, cost-effectiveness, and occurrence of complications were evaluated and compared in both groups. Results: Sixty pediatric patients with 93 refluxing ureters (41 females and 19 males) were included in the trial. The mean follow-up for all patients was 17.7 ± 7.1 months. Overall reflux resolution was 80% (36/45) of the ureters in group A after a single injection and 93.75% (45/48) of the ureters in group B. The difference between the two groups was not statistically significant concerning clinical or anatomical preoperative factors and surgical success rate. There was a statistically significant difference between the two groups in terms of operative time and hospital stay. Conclusion: This comparative study demonstrated a high success rate of open ureteral reimplantation (Lich-Gregoir) procedure over the endoscopic injection of Dx/HA therapy to manage primary VUR grades III-IV. Clinical Trial Number: NCT04798443.

Associations of insulin-induced lipodystrophy in children, adolescents, and young adults with type 1 diabetes mellitus using recombinant human insulin: a cross-sectional study.

OBJECTIVE: Insulin-induced lipodystrophy is of two types, lipohypertrophy and lipoatrophy. Lipodystrophy often leads to worsening of glycemic control in type 1 diabetes mellitus. Our objective was to identify the clinical, immunological, and other factor(s) associated with the development of lipodystrophy. METHODS: In this observational cross-sectional hospital-based study, 95 children, adolescents, and young adults with type 1 diabetes mellitus were observed for the development of lipodystrophy. Injection technique, insulin dose, and glycemic parameters were noted. Serum TNF-α, IL-1ß, and anti-insulin antibody levels were measured. Histopathological examination of the lipodystrophic area was done in a small number of people. RESULTS: Among the participants, 45.2% of participants had lipohypertrophy and 4.2% had lipoatrophy exclusively; 3.1% of participants had coexisting lipohypertrophy and lipoatrophy. Improper injection site rotation technique was more common in participants with lipohypertrophy in comparison to those without lipodystrophy. The age of onset of diabetes, duration of insulin use, and the number of times of needle reuse were not significantly different between the lipohypertrophy and nonlipodystrophy groups. Serum TNF-α, IL-1ß, and anti-insulin antibody levels; HbA1c; rate of hypoglycemia; and body weight-adjusted dose requirement were higher among the participants with lipohypertrophy. On histopathology, scant, or no inflammatory infiltrate was found in lipoatrophic and lipohypertrophic areas, respectively. CONCLUSION: Improper insulin injection technique and higher levels of proinflammatory cytokines and anti-insulin antibody are associated with lipodystrophy in type 1 diabetes mellitus. HbA1c and rate of hypoglycemia are higher in people with lipodystrophy.