A Systematic Review to Summarise and Appraise the Reporting of Surgical Innovation: a Case Study in Robotic Roux-en-Y Gastric Bypass.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

The synthetic TRPML1 agonist ML-SA1 rescues Alzheimer-related alterations of the endosomal-autophagic-lysosomal system.

Abnormalities in the endosomal-autophagic-lysosomal (EAL) system are an early event in Alzheimer's disease (AD) pathogenesis. However, the mechanisms underlying these abnormalities are unclear. The transient receptor potential channel mucolipin 1(TRPML1, also known as MCOLN1), a vital endosomal-lysosomal Ca2+ channel whose loss of function leads to neurodegeneration, has not been investigated with respect to EAL pathogenesis in late-onset AD (LOAD). Here, we identify pathological hallmarks of TRPML1 dysregulation in LOAD neurons, including increased perinuclear clustering and vacuolation of endolysosomes. We reveal that induced pluripotent stem cell (iPSC)-derived human cortical neurons expressing APOE ε4, the strongest genetic risk factor for LOAD, have significantly diminished TRPML1-induced endolysosomal Ca2+ release. Furthermore, we found that blocking TRPML1 function in primary neurons by depleting the TRPML1 agonist PI(3,5)P2 via PIKfyve inhibition, recreated multiple features of EAL neuropathology evident in LOAD. This included increased endolysosomal Ca2+ content, enlargement and perinuclear clustering of endolysosomes, autophagic vesicle accumulation and early endosomal enlargement. Strikingly, these AD-like neuronal EAL defects were rescued by TRPML1 reactivation using its synthetic agonist ML-SA1. These findings implicate defects in TRPML1 in LOAD EAL pathogenesis and present TRPML1 as a potential therapeutic target.

A 2-year Comparative Analysis of Outcomes and Endovascular Interventions in Radio-Cephalic vs. Brachio-Cephalic Fistulae.

BACKGROUND: Arterio-venous fistulae are often compromised by complications, notably thrombosis. We assess the 2 year follow-up data of a cohort of patients from a single vascular centre in the UK who underwent BCF or RCF creation with the objective of assessing the outcome differences and intervention rates between fistula types. MATERIALS AND METHODS: We retrospectively assessed a cohort of 195 patients who underwent creation of arterio-venous fistula (100 BCF, 95 RCF) between January 2016 and December 2018, following them up for 2 years assessing the outcomes and interventions on their AVFs. The outcomes assessed were primary and cumulative patency at 6 weeks, 6, 12 and 24 months. Multinomial logistic regression to account for confounding variables age, gender, procedure, side, anticoagulant, vessel size and co-morbidities was performed. A Kaplan-Meier analysis of time to endovascular intervention was also performed comparing RCF and BCF. RESULTS: Cumulative patency rates for BCF vs RCF were 91% vs. 89% at 6 weeks (X2 (3, N = 194) = 4.70, P = .19), 83% vs. 76% at 6 months (X2 (3, N = 188) = 7.72, P = .05), 78% vs. 69% at 12 months (X2 (4, N = 175) = 5.37, P = .25) and 68% vs. 65% at 24 months (X2 (4, N = 161) = 5.24, P = .24). Endovascular intervention rate becomes divergent at 5 months, with the steepest difference between 6 and 12 months. Comparative endovascular intervention rates between BCF and RCF were 20% vs. 31% at 6 months, 41% vs. 40% at 12 months and 40% vs. 49% at 24 months. CONCLUSION: RCF seem to have significantly lower patency at 6 months and have higher endovascular intervention rates compared to BCF. A focussed surveillance protocol could prove effective in improving outcomes for RCF.

A systematic review of robot-assisted anti-reflux surgery to examine reporting standards.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration's framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons' prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

A systematic review of robot-assisted cholecystectomy to examine the quality of reporting in relation to the IDEAL recommendations: systematic review.

INTRODUCTION: Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. METHODS: Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. RESULTS: Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. CONCLUSION: The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.

Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices.

OBJECTIVE: Outcome selection and reporting in studies of novel surgical procedures and devices lacks standardisation, hindering safe and effective evaluation. A core outcome set (COS) to measure and report in all studies of surgical innovation is needed. We explored outcomes in a specific sample of innovative surgical device case studies to identify outcome domains specifically relevant to innovation to inform the development of a COS. DESIGN: A targeted review of 11 purposive selected case studies of innovative surgical devices. METHODS: Electronic database searches in PubMed (July 2018) identified publications reporting the introduction and evaluation of each device. Outcomes were extracted and categorised into domains until no new domains were conceptualised. Outcomes specifically relevant to evaluating innovation were further scrutinised. RESULTS: 112 relevant publications were identified, and 5926 outcomes extracted. Heterogeneity in study type, outcome selection and reporting was observed across surgical devices. Categorisation of outcomes was performed for 2689 (45.4%) outcomes into five broad outcome domains. Outcomes considered key to the evaluation of innovation (n=66; 2.5%) were further categorised as surgeon/operator experience (n=40; 1.5%), unanticipated events (n=15, 0.6%) and modifications (n=11; 0.4%). CONCLUSION: Outcome domains unique to evaluating innovative surgical devices have been identified. Findings have been combined with multiple other data sources relevant to the evaluation of surgical innovation to inform the development of a COS to measure and report in all studies evaluating novel surgical procedures/devices.

Significance of preoperative thrombus burden in the prediction of a persistent type II and reintervention after infrarenal endovascular aneurysm repair.

BACKGROUND: Persistent type II endoleak has necessitated prolonged surveillance and is a reason for reintervention after infrarenal endovascular aneurysm repair (EVAR). The aim of this study was to assess the association of thrombus burden (TB) within the aneurysmal sac in the prediction of a persistent type II endoleaks. METHODS: Consecutive patients who underwent infrarenal EVAR from October 2009 to October 2017 in a single vascular network were included. TB was assessed on preoperative computed tomography angiogram and was defined as a percentage of thrombus across the maximal sac diameter in comparison with the luminal diameter measured orthogonally at the same level. Patients were categorized into three groups: low TB (<25%), medium TB (25%-50%), and high TB (>50%). All patients underwent postoperative EVAR surveillance comprising computed tomographic angiography or duplex ultrasound imaging. Type II endoleak observed for more than 1 year was defined as persistent type II endoleak. Odds ratio (OR) and Student's t-test were used to determine significance. RESULTS: Some 275 EVARs were performed in the study period. A total of 45 procedures were excluded because of either iliac-only intervention (n = 9), no preoperative information (n = 7), abandoned (n = 1), or less than 1 year's follow-up data (n = 28). For the 230 procedures included, the median follow-up was 43 (12-102) months. There were no significant differences between the groups for age, gender, and comorbidities nor preoperative sac diameter. There was high interobserver reliability with a kappa value of 0.89 (0.84-0.94) with a total discordance of 7% across the cohorts. Persistent type II endoleak occurred significantly more frequently with reduced TB: 41% of the low TB cohort compared with 4% of the high TB cohort (OR, 15.36 [3.5-67.3]; P = .0003). Reintervention was also significantly more likely to occur in the presence of a persistent type II endoleak compared with its absence; n = 12 of 13 (92%) patients who underwent reintervention had a persistent type II endoleak (OR, 43.4 [5.5-242]; P = .0003). Sac size reduction was significantly greater in medium TB and high TB cohorts when compared with low TB: -25% and -27% vs -15% (P = .0046 and P < .0001). Decreased TB was associated with a significant increase in inferior mesenteric artery (IMA) patency, the mean TB, where the IMA was patent, being 29% compared with 40% where the IMA was occluded P < .0001. When considered together, patients with a low TB and a patent IMA were even more likely to have a persistent type II endoleak when compared with those with a high TB and an occluded IMA (OR, 34.1 [1.99-583]; P = .015). CONCLUSIONS: Low TB is associated with increased rates of persistent type II endoleak, especially in the presence of a patent IMA. High TB is associated with increased sac regression and low reintervention rates. TB can be assessed reliably and could be used for risk stratification in the planning of infrarenal EVAR. Pre-emptive embolization of IMA or lumbar vessels in those with low TB may be beneficial. TB could be a useful tool for designing a post-EVAR surveillance regimen.

Vessel diameter and close surveillance helps predict early patency in native arteriovenous fistulas.

INTRODUCTION: Arteriovenous fistulas are the preferred method of vascular access for haemodialysis. Data suggests patency rates can be low and may be related to vessel diameters prior to creation. We use specific size criteria for fistula selection. We aimed to establish patency rates in relation to vessel size and whether other factors affect fistula patency. METHODS: Consecutive patients undergoing radiocephalic (RCF) or brachiocephalic (BCF) creation between 2016 and 2018 were analysed. Preoperative arterial and venous diameters were collected. Six-week and six-month primary and secondary patency rates were analysed to establish any impact of vessel size on patency and re-intervention rates between groups. A univariate analysis was performed. RESULTS: Ninety four RCFs and 101 BCFs were created. Median artery and vein size for RCF were 2.7 and 3.0 mm respectively. For BCF, they were 4.6 and 4.3 mm respectively. At 6-weeks, overall satisfactory patency for RCF and BCF combined was 91.8%. 89.7% demonstrated primary patency; 2.1% secondary patency. At 6-months, overall patency was 78.7%; 58.5% demonstrated primary patency, 20.2% secondary patency. A univariate analysis, for both groups, revealed vein size was a significant predictor of overall satisfactory patency at 6-weeks, with larger veins more likely to remain patent (p = 0.025 RCF, p = 0.007 BCF). However, artery size was not predictive (p = 0.1 RCF, p = 0.5 BCF). At 6-months, neither artery nor vein diameter were predictive in either group. When comparing size of vessel based on fistula type, vessels used to create RCFs were smaller than those for BCFs (p < 0.001). RCFs were more likely to receive endovascular intervention or occlude when compared to BCFs (p = 0.014). DISCUSSION: Excellent patency and maturation rates can be achieved using fairly strict vessel size criteria. Vein size might be the more important predictor of early success. RCFs can be challenging due to smaller vessels, but maturation rates can be optimised by close surveillance and aggressive re-intervention.

Safety and Validity of the Proposed European Society for Vascular Surgery Infrarenal Endovascular Aneurysm Repair Surveillance Protocol: A Single Centre Evaluation.

OBJECTIVE: Long term surveillance after endovascular aneurysm repair (EVAR) is essential to detect late complications, but there is variation in practice. The European Society for Vascular Surgery (ESVS) made a recommendation for a new surveillance protocol; one element involves risk stratifying patients depending on sac size reduction and presence of endoleak at their 30 day computed tomography angiogram into low risk groups (delayed imaging to five years) or higher risk groups (continue with the current protocol). The aim was to test this suggested protocol retrospectively within an EVAR patient cohort. METHODS: Data on EVARs performed from October 2009 to October 2019 were collected. Information gathered from an existing surveillance programme was used to assess the proposed ESVS protocol. All patients who underwent re-intervention were reviewed to see whether adopting the proposed ESVS protocol would have detected these events. RESULTS: In total, 309 procedures were included. Altogether, 219 of these patients had no endoleak (70.9%) and 86 had a type II (27.8%) endoleak. Only four developed a type I or III endoleak. No patient in the low risk cohort (no initial endoleak or sac shrinkage > 1 cm) required secondary intervention. Five year follow up data were available for 103 patients. In the type II endoleak group, there were 28 secondary interventions in 22 patients. No patient experienced a ruptured aneurysm within five years post-operatively. Had the proposed ESVS protocol been followed, all patients requiring a secondary intervention or with increasing sac size would have been detected/captured. Further, adherence to the ESVS guidelines would have resulted in 103 patients with a five year follow up history qualifying for reduced surveillance. A further 120 patients who had reached the three and four year follow up timepoints could have qualified for a reduced surveillance, reducing imaging cost further. CONCLUSION: Adopting the proposed ESVS EVAR surveillance protocol safely identified "low risk" patients who did not go on to require a secondary intervention. These patients could benefit from reduced surveillance scanning.

Detrimental effect of zwitterionic buffers on lysosomal homeostasis in cell lines and iPSC-derived neurons.

Good's buffers are commonly used for cell culture and, although developed to have minimal to no biological impact, they cause alterations in cellular processes such as autophagy and lysosomal enzyme activity. Using Chinese hamster ovary cells and induced pluripotent stem cell-derived neurons, this study explores the effect of zwitterionic buffers, specifically HEPES, on lysosomal volume and Ca2+ levels. Certain zwitterionic buffers lead to lysosomal expansion and reduced lysosomal Ca2+. Care should be taken when selecting buffers for growth media to avoid detrimental impacts on lysosomal function.

Feeding growth restricted premature neonates: a challenging perspective.

Nutrition in the postnatal period is essential to achieve optimal growth and maintain biochemical normality. Feeding growth-restricted premature neonates remains a big challenge for pediatricians and neonatologists. The choice of milk is one of the biggest challenges. Breast milk is recommended, although feeding with preterm formulas can ensure a more consistent delivery of optimal levels of nutrients. The timing of introduction of feeds and the rate of advancement of those feeds in preterm infants are both topics of significant controversy. Early feeding is advantageous because it improves the functional adaptation of the gastrointestinal tract and reduces the duration of total parenteral nutrition. A faster rate of advancement will also reduce the duration of need for parenteral nutrition. Despite this, enteral feeding is often delayed and is often slowly increased in high-risk infants because of a possible increased risk of necrotizing enterocolitis (NEC). Growth-restricted neonates are at increased risk of developing NEC due to a combination of antenatal and postnatal disturbances in gut perfusion. If enteral feeding is introduced earlier and advanced more quickly, this may lead to increased risk of NEC, but slower feeds extend the duration of parenteral nutrition and its risks and may have adverse consequences for survival, growth, and development. Premature infants pose a significant nutritional challenge. Overall, we would suggest the preferential use of human breast milk, early minimal enteral feeds, and standardized feeding protocols with cautious advancements of feeds to facilitate gastrointestinal adaptation and reduce the risk of NEC, however further research is needed.

Lack of a standardised UK care pathway resulting in national variations in management and outcomes of paediatric small area scalds.

INTRODUCTION: There is a paucity of evidence guiding management of small area partial thickness paediatric scalds. This has prevented the development of national management guidelines for these injuries. This research aimed to investigate whether a lack of evidence for national guidelines has resulted in variations in both management and outcomes of paediatric small area scalds across England and Wales (E&W). METHODS: A national survey of initial management of paediatric scalds ≤5% Total Body Surface Area (%TBSA) was sent to 14 burns services in E&W. Skin graft rates of anonymised burns services over seven years were collected from the international Burns Injury Database (iBID). Average skin grafting rates across services were compared. Length of stay and proportion of patients receiving general anaesthesia for dressing application at each service were also compared. RESULTS: All 14 burns services responded to the survey. Only 50% of services had a protocol in place for the management of small area burns. All protocols varied in how partial thickness paediatrics scalds ≤5% TBSA should be managed. There was no consensus as to which scalds should be treated using biosynthetic dressings. Data from iBID for 11,917 patients showed that the average reported skin grafting rate across all burns services was 2.3% (95% CI 2.1, 2.6) but varied from 0.3% to 7.1% (P<0.001). Service provider remained associated with likelihood of skin grafting when variations in the %TBSA case mix seen by each service were controlled for (χ(2)=87.3, P<0.001). The use of general anaesthetics across services varied between 0.6 and 35.5% (P<0.001). The median length of stay across services varied from 1 to 3 days (P<0.001). DISCUSSION: A lack of evidence guiding management of small-area paediatric scalds has resulted in variation in management of these injuries across E&W. There is also significant variation in outcomes for these injuries. Further research is indicated to determine if care pathways and outcomes are linked. An evidence-based national policy for the management of small area paediatric scalds would ensure that high quality, standardised care is delivered throughout E&W and variations in outcome are reduced.

Recognition and management of febrile convulsion in children.

Febrile convulsion is characterised by convulsion associated with fever in an infant or child aged between six months and six years. The febrile illness causing the convulsion should not be secondary to an intracranial infection (meningitis or encephalitis) or acute electrolyte imbalance. Most cases of febrile convulsion are short lived and self-terminating. However, a few cases of prolonged febrile convulsion may need anticonvulsant medication to stop the seizure. Management is mainly symptomatic, although anticonvulsants may have a role in a small number of children with complex or recurrent febrile convulsion. Referral to paediatric neurologists may be necessary in cases of complex or recurrent febrile convulsion, or in those where a pre-existing neurological disorder exists. One third of children will develop a further febrile convulsion during subsequent febrile illness. Nurses have a vital role in managing children with febrile convulsion, educating parents about the condition and dispelling myths. This article outlines the presentation, management, investigations and prognosis for febrile convulsion, indicating how nurses working in different clinical areas can help to manage this common childhood condition.

Coeliac disease in children.

Coeliac disease is an immune-mediated systemic disorder caused by ingestion of gluten. The condition presents classically with gastrointestinal signs including diarrhoea, bloating, weight loss and abdominal pain, but presentations can include extra-intestinal symptoms such as iron-deficiency anaemia, faltering growth, delayed puberty and mouth ulcers. Some children are at higher risk of developing coeliac disease, for example those with a strong family history, certain genetic disorders and other autoimmune conditions. If coeliac disease is suspected, serological screening with anti-tissue transglutaminase titres should be performed and the diagnosis may be confirmed by small bowel biopsy while the child remains on a normal (gluten-containing) diet. Modified European guidelines recommend that symptomatic children with anti-tissue transglutaminase titres more than ten times the upper limit of normal, and positive human leucocyte antigen (HLA)-DQ2 or HLA-DQ8 status, do not require small bowel biopsy for diagnosis of coeliac disease. Management of the disease involves strict adherence to a lifelong gluten-free diet, which should lead to resolution of symptoms and prevention of long-term complications. Healthcare professionals should be aware of the varied presentations of coeliac disease to ensure timely screening and early initiation of a gluten-free diet.