Associations Between Hypoglycemia Awareness Status and Symptoms of Hypoglycemia Among Adults with Type 1 or Insulin-Treated Type 2 Diabetes Using the Hypo-METRICS Smartphone Application.

Introduction: This study examined associations between hypoglycemia awareness status and hypoglycemia symptoms reported in real-time using the novel Hypoglycaemia-MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone application (app) among adults with insulin-treated type 1 (T1D) or type 2 diabetes (T2D). Methods: Adults who experienced at least one hypoglycemic episode in the previous 3 months were recruited to the Hypo-METRICS study. They prospectively reported hypoglycemia episodes using the app for 10 weeks. Any of eight hypoglycemia symptoms were considered present if intensity was rated between "A little bit" to "Very much" and absent if rated "Not at all." Associations between hypoglycemia awareness (as defined by Gold score) and hypoglycemia symptoms were modeled using mixed-effects binary logistic regression, adjusting for glucose monitoring method and diabetes duration. Results: Of 531 participants (48% T1D, 52% T2D), 45% were women, 91% white, and 59% used Flash or continuous glucose monitoring. Impaired awareness of hypoglycemia (IAH) was associated with lower odds of reporting autonomic symptoms than normal awareness of hypoglycemia (NAH) (T1D odds ratio [OR] 0.43 [95% confidence interval {CI} 0.25-0.73], P = 0.002); T2D OR 0.51 [95% CI 0.26-0.99], P = 0.048), with no differences in neuroglycopenic symptoms. In T1D, relative to NAH, IAH was associated with higher odds of reporting autonomic symptoms at a glucose concentration <54 than >70 mg/dL (OR 2.18 [95% CI 1.21-3.94], P = 0.010). Conclusion: The Hypo-METRICS app is sensitive to differences in hypoglycemia symptoms according to hypoglycemia awareness in both diabetes types. Given its high ecological validity and low recall bias, the app may be a useful tool in research and clinical settings. The clinical trial registration number is NCT04304963.

A Comparison of the Rates of Clock-Based Nocturnal Hypoglycemia and Hypoglycemia While Asleep Among People Living with Diabetes: Findings from the Hypo-METRICS Study.

Introduction: Nocturnal hypoglycemia is generally calculated between 00:00 and 06:00. However, those hours may not accurately reflect sleeping patterns and it is unknown whether this leads to bias. We therefore compared hypoglycemia rates while asleep with those of clock-based nocturnal hypoglycemia in adults with type 1 diabetes (T1D) or insulin-treated type 2 diabetes (T2D). Methods: Participants from the Hypo-METRICS study wore a blinded continuous glucose monitor and a Fitbit Charge 4 activity monitor for 10 weeks. They recorded details of episodes of hypoglycemia using a smartphone app. Sensor-detected hypoglycemia (SDH) and person-reported hypoglycemia (PRH) were categorized as nocturnal (00:00-06:00 h) versus diurnal and while asleep versus awake defined by Fitbit sleeping intervals. Paired-sample Wilcoxon tests were used to examine the differences in hypoglycemia rates. Results: A total of 574 participants [47% T1D, 45% women, 89% white, median (interquartile range) age 56 (45-66) years, and hemoglobin A1c 7.3% (6.8-8.0)] were included. Median sleep duration was 6.1 h (5.2-6.8), bedtime and waking time ∼23:30 and 07:30, respectively. There were higher median weekly rates of SDH and PRH while asleep than clock-based nocturnal SDH and PRH among people with T1D, especially for SDH <70 mg/dL (1.7 vs. 1.4, P < 0.001). Higher weekly rates of SDH while asleep than nocturnal SDH were found among people with T2D, especially for SDH <70 mg/dL (0.8 vs. 0.7, P < 0.001). Conclusion: Using 00:00 to 06:00 as a proxy for sleeping hours may underestimate hypoglycemia while asleep. Future hypoglycemia research should consider the use of sleep trackers to record sleep and reflect hypoglycemia while asleep more accurately. The trial registration number is NCT04304963.

Retrospective Comparison of Commercially Available Automated Insulin Delivery With Open-Source Automated Insulin Delivery Systems in Type 1 Diabetes.

BACKGROUND: Automated insulin delivery (AID) systems have shown to improve glycemic control in a range of populations and settings. At the start of this study, only one commercial AID system had entered the Austrian market (MiniMed 670G, Medtronic). However, there is an ever-growing community of people living with type 1 diabetes (PWT1D) using open-source (OS) AID systems. MATERIALS AND METHODS: A total of 144 PWT1D who used either the MiniMed 670G (670G) or OS-AID systems routinely for a period of at least three to a maximum of six months, between February 18, 2020 and January 15, 2023, were retrospectively analyzed (116 670G aged from 2.6 to 71.8 years and 28 OS-AID aged from 3.4 to 53.5 years). The goal is to evaluate and compare the quality of glycemic control of commercially available AID and OS-AID systems and to present all data by an in-depth descriptive analysis of the population. No statistical tests were performed. RESULTS: The PWT1D using OS-AID systems spent more time in range (TIR)70-180 mg/dL (81.7% vs 73.9%), less time above range (TAR)181-250 mg/dL (11.1% vs 19.6%), less TAR>250 mg/dL (2.5% vs 4.3%), and more time below range (TBR)54-69 mg/dL (2.2% vs 1.7%) than PWT1D using the 670G system. The TBR<54 mg/dL was comparable in both groups (0.3% vs 0.4%). In the OS-AID group, median glucose level and glycated hemoglobin (HbA1c) were lower than in the 670G system group (130 vs 150 mg/dL; 6.2% vs 7.0%). CONCLUSION: In conclusion, both groups were able to achieve satisfactory glycemic outcomes independent of age, gender, and diabetes duration. However, the PWT1D using OS-AID systems attained an even better glycemic control with no clinical safety concerns.

A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery - PREMIVALVE a cohort study.

The most common age-related heart valve diseases include aortic valve stenosis and mitral valve insufficiency. The suture material is not the focus of most studies. The aim of the study was to assess the performance of PremiCron suture material for cardiac valve reconstruction and/or replacement under clinical routine. Performance was evaluated using the incidence of major adverse cardiac and cerebrovascular events (MACCE) combined with endocarditis. Materials and methods: The study was designed as an international, prospective, bicentric, observational, single-arm study to evaluate the PremiCron suture material in cardiac valve surgery and compare the outcome with literature data regarding postoperative complications. The primary endpoint was a composite of MACCE acquired in the hospital, combined with endocarditis occurring up to 6 months postoperatively. The secondary parameters were intraoperative handling of the suture, incidence of MACCE and other relevant complications and quality of life up to 6 months after surgery. Patients were examined at discharge, 30 days, and 6 months postoperatively. Results: A total of 198 patients were enrolled in two centers in Europe. The cumulative primary endpoint event rate was 5.0%, lower than the reference value of 8.2% from the literature. Comparison of the incidence of individual MACCE until discharge and endocarditis rate 6 months postoperatively also showed that our data were within the range of the published rates. Quality of life significantly increased from preoperatively to 6 months after surgery. Ease of handling of the suture material was rated as very good. Conclusion: The PremiCron suture material is safe and very eligible for cardiac valve replacement and/or cardiac valve reconstruction in a broad patient population with a cardiac valve disorder treated under daily clinical practice.

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app.

INTRODUCTION: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. MATERIALS AND METHODS: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. RESULTS: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. CONCLUSION: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial.

BACKGROUND: Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. METHODS: A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. RESULTS: The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). CONCLUSION: The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).

Comparative Effectiveness of 4 Exercise Interventions Followed by 2 Years of Exercise Maintenance in Multiple Sclerosis: A Randomized Controlled Trial.

OBJECTIVE: To determine the effects of exergaming (EXE) on quality of life (QOL), motor, and clinical symptoms in multiple sclerosis (MS). We compared the effects of EXE, balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group on clinical and motor symptoms and quality of life (QOL) in people with MS (PwMS) and determined the effects of subsequent maintenance programs for 2 years in a hospital setting. DESIGN: A randomized controlled trial, using before-after test design. SETTING: University hospital setting. PARTICIPANTS: Of 82 outpatients with MS, 70 were randomized (N=70), and 68 completed the study. INTERVENTIONS: The initial high-intensity and high-frequency interventions consisted of 25 one-hour sessions over 5 weeks. After the 5-week-long initial intervention, the 2-year-long maintenance programs followed, consisting of 3 sessions per week, each for 1 hour. MAIN OUTCOME MEASURES: The primary outcome: Multiple Sclerosis Impact Scale (MSIS-29). SECONDARY OUTCOMES: Measures 5 aspects of health-related QOL (EuroQol 5-Dimension questionnaire), Beck Depression Inventory, 6-minute walk test (6MWT), Berg Balance Scale (BBS), Tinetti Assessment Tool (TAT), and static BAL (center of pressure). RESULTS: MSIS-29 improved most in EXE (11 points), BAL (6), and CYC (6) (all P<.05). QOL improved most in EXE (3 points), CYC, and BAL (2) (all P<.05). TAT and BBS improved significantly (P<.05) but similarly (P>.05) in EXE, BAL, and CYC. 6MWT improved most in EXE (57m), BAL (32m), and CYC (19m) (all P<.001). Standing sway did not change. Maintenance programs further increased the initial exercise-induced gains, robustly in EXE. CONCLUSIONS: A total of 25 sessions of EXE, BAL, CYC, and PNF, in this order, improved clinical and motor symptoms and QOL, and subsequent 2-year-long thrice weekly maintenance programs further slowed symptom worsening and improved QOL. EXE was the most and PNF was the least effective to improve clinical symptoms, motor function, and QOL in PwMS.

Eso-Sponge® for anastomotic leakage after oesophageal resection or perforation: outcomes from a national, prospective multicentre registry.

BACKGROUND: Anastomotic leakage (AL) after oesophagectomy and oesophageal perforations are associated with significant morbidity and mortality. Minimally invasive endoscopy is often used as first-line treatment, particularly endoluminal vacuum therapy (EVT). The aim was to assess the performance of the first commercially available endoluminal vacuum device (Eso-Sponge®) in the management of AL and perforation of the upper gastrointestinal tract (GIT). METHODS: The Eso-Sponge® registry was designed in 2014 as a prospective, observational, national, multicentre registry. Patients were recruited with either AL or perforation within the upper GIT. Data were collected with a standardized form and transferred into a web-based platform. Twenty hospitals were enrolled at the beginning of the study (registration number NCT02662777; http://www.clinicaltrials.gov). The primary endpoint was successful closure of the oesophageal defect. RESULTS: Eleven out of 20 centres recruited patients. A total of 102 patients were included in this interim analysis; 69 patients with AL and 33 with a perforation were treated by EVT. In the AL group, a closure of 91 per cent was observed and 76 per cent was observed in the perforation group. The occurrence of mediastinitis (P = 0.002) and the location of the defect (P = 0.008) were identified as significant predictors of defect closure. CONCLUSIONS: The Eso-Sponge® registry offers the opportunity to collate data on EVT with a uniform, commercially available product to improve standardization. Our data show that EVT with the Eso-Sponge® is an option for the management of AL and perforation within the upper GIT.

Efficient and safe glycaemic control with basal-bolus insulin therapy during fasting periods in hospitalized patients with type 2 diabetes using decision support technology: A post hoc analysis.

AIM: To evaluate the efficacy and safety of basal-bolus insulin therapy in managing glycaemia during fasting periods in hospitalized patients with type 2 diabetes. MATERIALS AND METHODS: We performed a post hoc analysis of two prospective, uncontrolled interventional trials that applied electronic decision support system-guided basal-bolus (meal-related and correction) insulin therapy. We searched for fasting periods (invasive or diagnostic procedures, medical condition) during inpatient stays. In a mixed model analysis, patients' glucose levels and insulin doses on days with regular food intake were compared with days with fasting periods. RESULTS: Out of 249 patients, 115 patients (33.9% female, age 68.3 ± 10.3 years, diabetes duration 15.1 ± 10.9 years, body mass index 30.1 ± 5.4 kg/m2 , HbA1c 69 ± 20 mmol/mol) had 194 days with fasting periods. Mean daily blood glucose (BG) was lower (modelled difference [ModDiff]: -0.5 ± 0.2 mmol/L, P = .006), and the proportion of glucose values within the target range (3.9-10.0 mmol/L) increased on days with fasting periods compared with days with regular food intake (ModDiff: +0.06 ± 0.02, P = .005). Glycaemic control on fasting days was driven by a reduction in daily bolus insulin doses (ModDiff: -11.0 ± 0.9 IU, P < .001), while basal insulin was similar (ModDiff: -1.1 ± 0.6 IU, P = .082) compared with non-fasting days. Regarding hypoglycaemic events (BG < 3.9 mmol/L), there was no difference between fasting and non-fasting days (χ2 0.9% vs. 1.7%, P = .174). CONCLUSIONS: When using well-titrated basal-bolus insulin therapy in hospitalized patients with type 2 diabetes, the basal insulin dose does not require adjustment during fasting periods to achieve safe glycaemic control, provided meal-related bolus insulin is omitted and correction bolus insulin is tailored to glucose levels.

Criterion validity and reliability of the International Physical Activity Questionnaire - Hungarian short form against the RM42 accelerometer.

BACKGROUND: Physical inactivity is a global phenomenon in European welfare countries. Proper monitoring is essential to measure the physical activity level of the population. METHODS: In the Hungarian cohort of the European Physical Activity and Sport Monitoring System (EUPASMOS) project, our participants (N = 598) completed sociodemographic questions and the International Physical Activity Questionnaire - short form (IPAQ-SF) survey. The validity and reliability of the subjective measurement tool were examined, IPAQ-SF outcomes were contrasted against triaxial RM42 accelerometer wore for 7 consecutive days. RESULTS: The IPAQ-SF showed moderate internal consistency (Cronbach Alpha = 0.647). The concurrent validity of the IPAQ-SF to triaxial accelerometer indicated a significant weak-to-moderate correlation (R = 0.111-0.338, p = 0.042; p < 0.001). The test-retest reliability showed a significant correlation between two measurements (R = 0.788-0.981, p < 0.001). CONCLUSION: The Hungarian version of the IPAQ-SF had excellent test-retest reliability, but low-to-fair concurrent validity for moderate and vigorous physical activity, walking and sitting time, as compared to the objective criterion measure among Hungarian adults.

Assessment of health-related quality of life and patient's knowledge in chronic non-specific low back pain.

BACKGROUND: Chronic non-specific low back pain syndrome (cnsLBP) is a severe health problem in developed countries, which has an important effect on patients' quality of life and is highly determined by socio-demographic factors and low back pain specific knowledge. We examined patients' health-related quality of life according to the results of the Short Form Health Survey (SF-36), low back pain knowledge (LBPKQ) and the social determinants of the participants. METHODS: We carried out our research in the first half of 2015 in Southern Transdanubia, Hungary. The examination included 1155 respondents living with chronic non-specific low back pain. The confidence interval of 95% was used, and the level of. significance was p < 0.05 using SPSS 22.0 software. RESULTS: The SF-36 questionnaire is suitable for the examination of patients' health-related quality of life (Cronbach's Alpha> 0.76), as the LBPKQ's Cronbach's Alpha was 0.726 also, which showed good validity. Longer-term disease meant a lower health-related quality of life (p < 0.05). A greater decrease of function (Roland Morris scores (RM)) accounts for a lower HRQoL and higher knowledge level. We found significant differences in LBPKQ scores according to sociodemographic parameters. The general health status was positively correlated with LBPKQ (p = 0.024) adjusted for demographic and pain and functional status. CONCLUSION: The negative effect of the symptoms on patients' quality of life is proved, which is determined by different socio-demographic parameters furthermore by knowledge. Above all could be useful information for professionals to adopt the right interventions.

Patients with healed diabetic foot ulcer represent a cohort at highest risk for future fatal events.

Patients with previous diabetic foot ulcer are prone to re-ulceration and (re)amputation, to various comorbidities, have significantly impaired quality of life and increased mortality. We aimed to evaluate the risk of foot related complications and mortality in a high-risk population of patients with healed diabetic foot syndrome over a decade. 91 patients with recently healed diabetic foot ulcer were invited for follow-up at 1, 6 and 11 years after inclusion. Patient characteristics at inclusion were: 40 women, 65 ± 11 years, diabetes type 1 (n = 6) or 2 (n = 85), BMI 28.5 ± 4.4 kg/m2, and HbA1c 68 ± 17 mmol/mol. Comorbidities included neuropathy (n = 91), peripheral artery disease (PAD), history of minor (n = 25) or major (n = 5, 5.5%) amputation, nephropathy (n = 40) and retinopathy (n = 53). Ulceration recurred in 71 (65%) patients, time to first recurrence was 1.8 ± 2.4 years (mean ± SD). 21 patients had to undergo (re)amputation (minor n = 19, major n = 2), time to amputation was 3.6 ± 1.9 years. Over time, 3 further major amputations were required in patients with an initial minor amputation. Thirty-three (36%) of the initially included patients completed the follow-up period of 11.0 ± 0.6 years. 58 patients (64%) died during the observational period, time to death was 5 ± 3 years in this group. We found overall high mortality of 64% throughout the follow-up period of 11 years in high-risk patients with healed diabetic foot syndrome. Presence of PAD, prior amputation and nephropathy as well as poor glycemic control were significantly predictive for death.

Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

BACKGROUND: This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures. METHODS: This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handling characteristics of the suture. Patients and professionals used the Patient-Observer-Scar-Assessment-Scale (POSAS) to rate scar quality. Adverse events were monitored until 3 months postoperatively. RESULTS: Handling characteristics of Novosyn® Quick were in median rated very good by both general surgeons and paediatric surgeons. Patient components of POSAS (six questions; ten-level Likert scale; best possible score six) scored in median (range) 8.5 (6-28) in the paediatric group versus 12 (6-38) in the adult group, P = 0.01. Patients` overall opinions of POSAS were similar in both groups [mean (SD), 1.86 (0.99) in the paediatric group versus 2.08 (1.35) in the adult group, P = 0.3536]. Observer component of POSAS (six parameters; ten-level numeric rating scale, best possible score six) scored comparably in both groups [median (range), 8 (6-29) in the paediatric group versus 10 (6-28) in the adult group, P = 0.1403]. Observers overall opinion of POSAS favoured the paediatric patients group [mean (SD), 1.48 (0.61) versus 1.92 (1.06) in the adult group, P = 0.0131]. Adverse events in relation to wound healing were not observed in both patient groups. CONCLUSIONS: Our findings indicate, that Novosyn® Quick is safe and reliable for skin closure in adults and paediatric patients and can be regarded as a viable alternative to Vicryl® Rapide. TRIAL REGISTRATION: This trial was registered prospectively with ClinicalTrials.gov under the registration number NCT02680886 on 5 February 2016. The trial was approved by the Institutional Review Boards of both study locations (France: CCTIRS N° 16-103 and CNIL:MMS/CWR/AR163920; Germany: 398/15).

Lower plasma insulin levels during overnight closed-loop in school children with type 1 diabetes: Potential advantage? A randomized cross-over trial.

BACKGROUND: Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model-based closed-loop algorithm compared to an open-loop administration. METHODS: Fifteen children with type 1 diabetes, 6-12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper. RESULTS: Results of paired sample t-tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l; t(13) = 2.13, p = .03, effect size d = 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l; t(13) = 1.24, p = .12, d = 0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop (mean difference 0.10 UI; t(12) = 2.45, p = .02, d = 0.68). CONCLUSIONS: Lower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels, whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective.

Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study.

INTRODUCTION: Coronary artery bypass grafting (CABG) is performed to improve quality of life and to reduce cardiac-related mortality and morbidity in patients with coronary artery disease (CAD). The aim of the present observational study was to assess the performance of a new suture material (Optilene) for anastomosis construction in CABG surgery using a routine clinical procedure. Performance was assessed using the incidence of major adverse cardiac and cerebrovascular events (MACCE). METHODS: The study was designed as an international, multi-centre, prospective cohort study to evaluate the safety and efficacy of a new non-absorbable monofilament for CABG surgery compared to data published in a previous meta-analysis. Optilene suture was used to create the distal and proximal coronary artery anastomoses. The primary endpoint was the cumulative MACCE rate up to discharge. Secondary parameters were intraoperative handling of the suture material and QoL up to 3 months after surgery. Patients were examined 30 days and 3 months postoperatively. RESULTS: In total, 199 patients were enrolled in 3 centres in Europe. The cumulative CABG adverse event rate up to the day of discharge was 3%, in contrast to the 8.46% given by the data generated by Nalysnyk et al. A t-test showed that our CABG rate was significantly lower. QoL significantly increased from preoperatively until 3 months after surgery. Ease of handling the suture material was rated as very good. CONCLUSION: Optilene suture material represents a safe and effective alternative to existing sutures used in CABG surgery for anastomosis construction.

Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study.

INTRODUCTION: Various suture materials and suture techniques are used to perform gastrointestinal anastomosis after tumour resection, but the best combination is still a matter of debate. METHODS: This multi-centre, international, single-arm, prospective observational study aimed at demonstrating the non-inferiority of a mid-term absorbable monofilament in comparison to braided sutures in gastrointestinal anastomosis. Monosyn suture was used to create the gastrointestinal anastomosis and the frequency of anastomotic leakage until day of discharge was chosen as the primary parameter. The outcome was compared to the results published for braided sutures in the literature. Secondary parameters were the time to perform the anastomosis, length of hospital stay, costs, and postoperative complications. RESULTS: The anastomosis leakage rate was 2.91%, indicating that Monosyn suture was not inferior to braided sutures used in gastrointestinal anastomosis. Of the reported anastomotic suture techniques, the single layer continuous method was the fastest and most economical technique in the present observational study. CONCLUSION: Monosyn suture is safe and effective in gastrointestinal anastomosis and represents a good alternative to other sutures used for gastrointestinal anastomosis. With regard to safety, time and cost-efficiency, the single-layer continuous technique should be considered a preferred method. The transfer of results from clinical studies into daily practice with regard to surgical techniques for gastrointestinal anastomosis should be further evaluated in larger studies or in nationwide registries.

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes.

Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo- and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland-Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non-esterified-fatty-acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197:2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs ± standard deviation in the entire glycaemic range were 13.2% ± 10.9% (Abbott), 16.8% ± 12.3% (Dexcom) and 21.4% ± 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.

A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412].

BACKGROUND: Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy. METHODS: In this prospective, controlled, randomized, patient-blinded, monocenter phase I-II study, 62 patients received either the hydrogel A-Part-Gel(®) as an anti-adhesive barrier or were untreated after primary elective median laparotomy. Primary endpoint was the occurrence of peritonitis and/or wound healing impairment 28 ± 10 days postoperatively. As secondary endpoints anastomotic leakage until 28 days after surgery, adverse events and adhesions were assessed until 3 months postoperatively. RESULTS: A lower rate of wound healing impairment and/or peritonitis was observed in the A-Part Gel(®) group compared to the control group: (6.5 vs. 13.8 %). The difference between the two groups was -7.3%, 90 % confidence interval [-20.1, 5.4 %]. Both treatment groups showed similar frequency of anastomotic leakage but incidence of adverse events and serious adverse events were slightly lower in the A-Part Gel(®) group compared to the control. Adhesion rates were comparable in both groups. CONCLUSION: A-Part Gel(®) is safe as an adhesion prophylaxis after abdominal wall surgery but no reduction of postoperative peritoneal adhesion could be found in comparison to the control group. This may at least in part be due to the small sample size as well as to the incomplete coverage of the incision due to the used application. TRIAL REGISTRATION: NCT00646412.

Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

BACKGROUND: Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication. Trauma to the abdominal wall can be reduced by improvements in suture technique as well as suture material. Several factors, such as stitch length, suture tension, elasticity, and tensile strength of the suture material are discussed and currently under investigation. A Swedish randomized controlled trial showed a significant reduction in the incisional hernia rate by shortening the stitch length. However, a non-elastic thread was used and follow-up ended after 12 months. Therefore, we designed a multicenter, international, double-blinded, randomized trial to analyze the influence of stitch length, using an elastic, extra-long term absorbable monofilament suture, on the long term clinical outcome of abdominal wall closure. METHODS: In total, 468 patients undergoing an elective, median laparotomy will be randomly allocated to either the short stitch or the long stitch suture technique for abdominal wall closure in a 1:1 ratio. Centers located in Germany and Austria will participate. The primary endpoint measure is the incisional hernia rate 1 year postoperatively, as verified by ultrasound. The frequency of short term and long term complications as well as costs, length of hospital stay and patients' quality of life (EQ-5D-5 L) will be considered as secondary parameters. Following hospital discharge, patients will be examined after 30 days and 1, 3, and 5 years after surgery. DISCUSSION: This study will provide further evidence on whether a short stitch suture technique in combination with an elastic, extra-long term absorbable monofilament suture can prevent incisional hernias in the long term, compared with the long stitch suture technique. TRIAL REGISTRATION: NCT01965249 .