Prospective Controlled Trial Research Articles

Virtual Surgical Guidance Improves Quality of Life Following Scapular Free-Flap Reconstruction of Maxillary Defects

BackgroundThe best way for maxillary reconstruction remains the subject of debate, with negative impacts on the patient’s quality of life (QOL). PurposeThis study was designed to evaluate the QOL outcomes following maxillary reconstruction using a scapular-free flap, with and without the computer-aided design and computer-aided manufacturing (CAD/CAM) technique. Study design and patientsA prospective randomized controlled clinical trial was performed following the CONSORT checklist. To be included, patients suffering from maxillary defects without previous surgery or lymph node involvement were selected. Patients with poor oncological prognosis, deficient performance status, preoperative chemotherapy, or radiotherapy, besides vascular contraindications, were excluded. Predictor variableThe predictor variable was the reconstruction technique, grouped into two equal categories. Patients were randomly assigned to reconstruction with a scapular-free flap, with the control group not utilizing a guide and the study group utilizing a CAD/CAM-customized guide. Outcome variableThe primary outcome variable was the various domains of QOL, measured using the University of Washington-QOL (UW-QOL) score, 12 months after reconstruction. Covariatesage; sex; scapular flap side; and maxillary defect tumour type, histopathology, side, length, class, sagittal, and axial differential areas were considered. AnalysesShapiro-Wilk and Kolmogorov-Smirnov tests were performed for normality. For comparisons between the two groups, Student’s t-test and Mann-Whitney test were used. The category variables were compared using the chi-square test. p ≤ 0.05 was considered statistically significant. ResultsThe sample was composed of twenty-two eligible patients, eleven in each group. The mean age of the control group was (50.09±17.14) years, and 45.45% were male, while in the study group, the mean age was (48.36±14.14) years, with 36.36% male. All the patients were evaluated, showing statistically significant differences between control and study groups in terms of pain, appearance, chewing, swallowing, speech, and shoulder (p ≤ 0.05), indicating that the scapular-free flap with a CAD/CAM osteotomy guide had improved the patient's QOL. ConclusionsThe findings of this study indicate that VSP with a CAD/CAM customized osteotomy guide using a scapular-free flap can improve QOL in maxillary reconstruction in terms of pain, appearance, chewing and swallowing food, pronouncing words, and shoulder QOL outcomes.

Abstract 2: Intracranial Hemorrhage Managed By A Mobile Stroke Unit

Background: Mobile stroke units (MSUs) improve outcomes in thrombolytic-eligible ischemic stroke patients. Outcomes of MSU management in patients with intracranial hemorrhage (ICH) have not been reported. Methods: We conducted a retrospective review of ICH patients enrolled in the Benefits of Stroke Treatment Using a Mobile Stroke Unit (BEST-MSU), a prospective multicenter controlled trial comparing MSU with standard EMS management (SM). The primary outcome was utility weighted modified Rankin Scale (uw-mRS) at 90 days; secondary outcomes were hematoma expansion, length of inpatient stay, favorable discharge disposition or 90-day mRS, and mortality. Groups were compared using Chi-square or Fisher’s exact tests for categorical variables, and two sample t-test or Wilcoxon rank sum test for continuous variables. Adjusted analysis was performed to evaluate the relationship between the intervention group and uw-mRS at 90 days. Kaplan-Meier curves and log-rank test were used to compare the survival by 90 days between groups. Results: 201 ICH patients were identified; 102 in the MSU and 99 in the SM groups. MSU patients had more antiplatelet/antithrombotic (AP/AT) use (30.4% vs 15.2%, p=0.016); edema was more frequent in the SM group (72.7% vs 52.0%, p = 0.004). Initial ICH volume was similar between MSU and SM groups (11.50 mL [5.0, 22.0] vs. 9.0 mL [5.0, 20.0], p = 0.62). Anti-hypertensives were given earlier on the MSU (39.0 min [31.00, 45.00] vs 61.0 min [46.50, 75.25], p<0.001), and resulted in shorter time to systolic blood pressure (SBP) < 150mmHg (52 min vs. 121 min, p<0.001). The mean uw-mRS at 90 days was 0.364 ± 0.361 in the MSU and 0.465 ± 0.360 in the SM group (p=0.50, adjusted for AP/AT and edema). There was no difference in hematoma expansion, length of stay, discharge disposition or 90-day mRS. Higher mortality was noted after 5 days post-ictus in the MSU group (26.5% vs. 14.1%, p = 0.04). Conclusion: In ICH patients, MSU management resulted in faster treatment and time to target SBP with similar clinical outcomes except higher late mortality. Further study of the impact of prehospital ICH management including BP reduction and AT/AP reversal are required.

DOP29 Capsule endoscopy-guided proactive treatment versus standard treatment of patients with quiescent Crohn’s Disease: The CURE-CD randomized controlled trial

Abstract Background Optimal strategies for treat-to-target in Crohn’s disease (CD) are still being sought. We aimed to examine the value of capsule endoscopy (CE) to guide proactive treatment optimization in patients with CD Methods A prospective randomized controlled clinical trial with temporally-restricted blinding. Patients with CD involving the small bowel who were in clinical remission (CDAI<150) for over three months were enrolled. Baseline clinical, biomarker, imaging, patency capsule and CE assessments were performed. ‘High risk’ patients, defined as CE Lewis score ≥350 were randomized to either proactive treatment optimization or continued standard care for 24 months. ‘Low risk’ patients with Lewis score<350 continued their standard care. All patients repeated CE every six months for 24 months. Primary outcome was the rate of clinical exacerbation (CDAI increase>70 points and CDAI>150 or hospitalization/surgery) in the standard-care versus the proactive-care sub-groups of high-risk patients, at 24 months. Secondary outcomes included risk of flare in the low-risk versus the standard-care high-risk arms, and predictive profiles for flare of calprotectin, MRI, intestinal ultrasound and Lewis score. Results Out of 118 screened patients, 60 were enrolled (20 in each of the three arms). Treatment intensification in CE-determined high-risk group, who were allocated to proactive treatment, comprised biologic dose-escalation (n=11/20), starting a biologic (8/20) or swapping a biologic (1/20) at study entry. Notably, 9/20 proactive-group patients underwent a second optimization following detected inflammation on subsequent semi-annual CE studies. Clinical exacerbation by 24 months (primary outcome) occurred in 5/20 (25%) of the high-risk proactive-treatment group versus 14/20 (70%) of the high-risk standard-care group (OR=0.14, 95%CI 0.04-0.57, p=0.006). For secondary outcomes, the rate of clinical flare in the standard-care low-risk group was numerically but not significantly lower than in standard-care high-risk group (9/20 versus 14/20, respectively, OR 0.3, 0.1-1.3, P=0.11). Among all patients continuing standard care, baseline CE Lewis score was higher among relapsers versus non-relapsers (median 450, IQR [225-900] versus 225, [135-600], respectively, p=0.03). Of 251 CE ingested, there was a single (0.4%) temporarily-retained CE, which resolved spontaneously. Conclusion In a randomized strategy-finding controlled trial, proactive treatment optimization based on CE findings in patients with CD in remission, proved safe and superior for prevention of disease exacerbation compared with continued standard care. NCT03555058

Effectiveness of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait: A prospective randomized control trial

BackgroundIn-toeing gait is defined as the internal rotation of the long axis of the foot to the line of progression. Although most of the time it is corrected spontaneously but sometimes causes torsional misalignment syndrome and maybe patellofemoral instability and arthritis of the knee. Research questionWhat is the effect of gait plate insoles and lateral sole wedged shoes on foot progression angle (FPA) in children with in-toeing? MethodIn this study, a randomized control trial was conducted with 11 participants (18 feet) who were girls aged between seven and ten years old. They were randomly assigned to either the gait plate group (6 girls, 11 feet) or the lateral sole wedge group (5 girls, 11 feet). The foot progression angle was measured using the RS scanner pressure platform before and after four weeks of intervention, both with and without interventions. The interaction effects of time and group on outcomes were analyzed using Mixed ANOVA and post-hoc complementary tests with a confidence interval of 95%. ResultsIt was observed that none of the interventions had an immediate impact on the FPA (P > 0.05). However, after four weeks, the FPA increased by 9.96 degrees with the lateral sole wedge and by 3.51 degrees with the gate plate insole. During the immediate and short-term evaluation, no significant difference was noticed between the two groups (P > 0.05). However, there was a large effect size (eta square = 0.269) observed in the time group interaction between the two groups (P = 0.028). SignificanceConservative methods like using a gait plate insole or modifying shoes with a lateral sole wedge can improve the foot progression angle in children with in-toeing gait. However, longer studies with larger sample sizes are needed to reach a conclusion.

COMPARISON OF PAIN AND EXTENT OF ANAESTHESIA IN DIGITAL BLOCKS FOR ISOLATED FINGER LACERATIONS: A RANDOMIZED CONTROLLED TRIAL

BackgroundDigital injuries are among the most common presentations to the emergency department. In order to sufficiently examine and manage these injuries, adequate, prompt, and predictable anaesthesia is essential. In this trial, we aim to primarily compare the degree of pain and anaesthesia onset time between the two-injection dorsal block technique (TD) and the single-injection volar subcutaneous block technique (SV). Further, we describe the temporal and anatomical effects of both techniques for an accurate delineation of the anesthetized regions.MethodsA single-centre prospective randomized controlled trial involving patients presenting with isolated wounds to the fingers requiring primary repair under local anaesthesia. Patients were randomized to either the SV or TD blocks. The primary outcome was procedure-related pain (Numerical Rating Scale). Further, we assessed the extent of anaesthesia along with the anaesthesia onset time.ResultsA total of 100 patients were included in the final analysis, 50 on each arm of the study. The median pain score during injection was significantly higher in patients who received TD block than patients who received SV block (median [interquartile range] = 4 [2.25, 5] vs. 3 [2, 4], respectively, P = 0.006). However, anaesthesia onset time was not statistically different among the groups (P = 0.39). The extent of anaesthesia was more predictable in the dorsal block compared to the volar block.ConclusionThe single-injection volar subcutaneous blocks are less painful with a similar anaesthesia onset time. Injuries presenting in the proximal dorsal region may benefit from the two-injection dorsal blocks, given the anatomical differences and timely anaesthesia of the region.

MANAGEMENT OF PROXIMAL HUMERUS FRACTURES IN ADULTS

Introduction: Proximal humerus fractures, more common in women and increasingly prevalent with age due to falls, pose a challenge in orthopaedic care, often leading to persistent pain and reduced shoulder function. This systematic review aims to evaluate diverse management strategies for these fractures in adults, analysing their effectiveness, complications, and patient-reported outcomes to guide treatment decisions. Methods: The researchers in this study followed the 2020 Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines to ensure that their work met the required standards. This was done to ensure the precision and reliability of the conclusions derived from the research. Result Our search produced 13 results. After looking at the titles and summaries, we found several papers that fit our criteria. At first, we excluded few articles because they were written in review and case report style. But after reading the full papers carefully, we included five papers in our final analysis. These papers included prospective, retrospective studies, and prospective randomized control trial study. Conclusion: This comprehensive study compared ORIF, HA, and RSA in PHF patients, revealing that ORIF was preferred in younger patients with simpler fractures, while RSA was favoured in older patients with complex fractures. ORIF demonstrated better motion than HA, but higher reoperation rates were noted for ORIF and HA compared to RSA, essential information for patient discussions. Postoperative fractures were prevalent, highlighting a need for counselling to prevent future falls and fractures post-PHF treatment. Despite prior inconclusive studies, the need to reduce unnecessary surgeries, especially in the elderly, remains crucial to minimize complications and healthcare costs amidst the shifting treatment landscape.

Reducing the incidence of surgical site infection after ventral hernia repair: Outcomes from the RINSE randomized control trial

BackgroundThe clinical and financial impact of surgical site infection after ventral hernia repair is significant. Here we investigate the impact of dual antibiotic irrigation on SSI after VHR. MethodsThis was a multicenter, prospective randomized control trial of open retromuscular VHR with mesh. Patients were randomized to gentamicin ​+ ​clindamycin (G ​+ ​C) (n ​= ​125) vs saline (n ​= ​125) irrigation at time of mesh placement. Primary outcome was 30-day SSI. ResultsNo significant difference was seen in SSI between control and antibiotic irrigation (9.91 vs 9.09 ​%; p ​= ​0.836). No differences were seen in secondary outcomes: SSO (11.71 vs 13.64 ​%; p ​= ​0.667); 90-day SSO (11.1 vs 13.9 ​%; p ​= ​0.603); 90-day SSI (6.9 vs 3.8 ​%; p ​= ​0.389); SSIPI (7.21 vs 7.27 ​%, p ​= ​0.985); SSOPI (3.6 vs 3.64 ​%; p ​= ​0.990); 30-day readmission (9.91 vs 6.36 ​%; p ​= ​0.335); reoperation (5.41 vs 0.91 ​%; p ​= ​0.056). ConclusionDual antibiotic irrigation with G ​+ ​C did not reduce the risk of surgical site infection during open retromuscular ventral hernia repair.

Maternal recorded voice played to preterm infants in incubators reduces her own depression, anxiety and stress: a pilot randomized control trial

Objective To study the effects of playing mother’s recorded voice to preterm infants in the NICU on their mothers’ mental health as measured by the Depression, Anxiety and Stress Scale −21 (DASS-21) questionnaire. Design/Methods This was a pilot single center prospective randomized controlled trial done at a level IV NICU. The trial was registered at clinicaltrials.gov (NCT 04559620). Inclusion criteria were mothers of preterm infants with gestational ages between 26wks and 30 weeks. DASS-21 questionnaire was administered to all the enrolled mothers in the first week after birth followed by recording of their voice by the music therapists. In the interventional group, recorded maternal voice was played into the infant incubator between 15 and 21 days of life. A second DASS-21 was administered between 21 and 23 days of life. The Wilcoxon rank-sum test was used to compare DASS-21 scores between the two groups and Wilcoxon signed-rank test was used to compare the pre- and post-intervention DASS-21 scores. Results Forty eligible mothers were randomized: 20 to the intervention group and 20 to the control group. The baseline maternal and neonatal characteristics were similar between the two groups. There was no significant difference in the DASS-21 scores between the two groups at baseline or after the study intervention. There was no difference in the pre- and post-interventional DASS-21 scores or its individual components in the experimental group. There was a significant decrease in the total DASS-21 score and the anxiety component of DASS-21 between weeks 1 and 4 in the control group. Conclusion In this pilot randomized control study, recorded maternal voice played into preterm infant’s incubator did not have any effect on maternal mental health as measured by the DASS-21 questionnaire. Data obtained in this pilot study are useful in future RCTs (Randomized Controlled Trial) to address this important issue.

Minimizing Redislocation Rates and Restoring Function After Patella Dislocation: A Critically Appraised Topic.

Patella dislocation is a common knee injury resulting in decreased function, increased knee pain, and a higher risk of recurrent patella dislocation. Patients with patella instability are treated surgically or conservatively with physical therapy to minimize redislocation risk and restore function. In individuals with a patella dislocation, how does treatment (conservative therapy versus medial patellofemoral ligament [MPFL] surgery) affect redislocation rates and patient-perceived function? This critically appraised topic included 3 studies assessing outcomes in individuals with patella instability treated with MPFL surgery or conservative management. Outcomes included comparing redislocation rates and Kujala scale perceived knee function between participant groups. Surgery included MPFL reconstruction (MPFL-R) in 1 randomized controlled trial and 1 prospective controlled trial and MPFL repair in another randomized controlled trial. Conservative treatment included physical therapy and bracing. All 3 studies demonstrated significantly lower redislocation rates in individuals managed with surgery versus conservative treatment. Reported knee function was significantly higher in the MPFL-R group compared with individuals conservatively managed at 2-year follow-up but not at 1year. No significant difference in knee function was present between individuals receiving MPFL repair or conservative management at a 2-year follow-up. There is moderate-level evidence to support a significant decrease in patella redislocation rates in individuals managed with MPFL surgery compared with conservative treatment. The reviewed studies suggest a significant improvement in patient-perceived knee function at 2years following MPFL-R but no difference at 1year following MPFL-R or 2years after MPFL repair. Strength of Recommendations: Grade B evidence supports lower patella redislocation rates with MPFL surgery compared with nonsurgical treatment. Furthermore, this evidence suggests a potential benefit in perceived knee function 2years after MPFL-R compared with conservative management.

The impact of ketorolac and paracetamol on post-operative pain and analgesic consumption post-dental extraction

Background: Despite being very popular, there is limited direct comparative research that has evaluated their efficacy in post-extraction pain control between ketorolac and paracetamol. Those undertaken have shown varied results; some show that ketorolac is superior in pain relief and duration of action and others show no significant difference in efficacy between the two. This discrepancy underlines the need for further research that is important in determining the relative efficacy of the two analgesics in those patients undergoing dental extractions, something that is very important in guiding the choice of analgesic for the clinician to use in the emergency room for dental patients. Aims and Objectives: This study aimed to compare the analgesic efficacy of paracetamol (500 mg) and ketorolac (10 mg) in managing acute pain following dental extractions. Materials and Methods: A prospective, randomized, and double-blind controlled trial was conducted on 80 patients undergoing single tooth extraction. Participants were allocated to receive either paracetamol 500 mg or ketorolac 10 mg orally post-extraction. Pain intensity was assessed using the visual analog scale at predetermined intervals post-extraction. Secondary outcomes included time to first analgesic request besides total analgesic consumption over 24 h. Results: Patients from Group II (ketorolac) demonstrated lower intensity pain scores at all-time points post-extraction compared to Group I (paracetamol). On the other hand, Group-I (ketorolac) demonstrated an extended time to the first analgesic request (P = 0.914) and lower total analgesic consumption (P = 0.0001) in the first 24-h post-extraction than Group-I (paracetamol). Conclusion: Ketorolac (10 mg) functioned better for pain than paracetamol (500 mg) in reducing pain intensity following dental extractions, with a longer duration of analgesic effect and reduced need for additional analgesia. These findings suggest that ketorolac may be preferred over paracetamol for immediate post-operative pain management within dental extractions, considering patient-specific contraindications and risk factors.

Simulation to become a better neurosurgeon. An international prospective controlled trial: The Passion study

IntroductionSurgical training traditionally adheres to the apprenticeship paradigm, potentially exposing trainees to an increased risk of complications stemming from their limited experience. To mitigate this risk, augmented and virtual reality have been considered, though their effectiveness is difficult to assess. Research questionThe PASSION study seeks to investigate the improvement of manual dexterity following intensive training with neurosurgical simulators and to discern how surgeons' psychometric characteristics may influence their learning process and surgical performance. Material and methodsSeventy-two residents were randomized into the simulation group (SG) and control group (CG). The course spanned five days, commencing with assessment of technical skills in basic procedures within a wet-lab setting on day 1. Over the subsequent core days, the SG engaged in simulated procedures, while the CG carried out routine activities in an OR. On day 5, all residents' technical competencies were evaluated. Psychometric measures of all participants were subjected to analysis. ResultsThe SG demonstrated superior performance (p < 0.0001) in the brain tumour removal compared to the CG. Positive learning curves were evident in the SG across the three days of simulator-based training for all tumour removal tasks (all p-values <0.05). No significant differences were noted in other tasks, and no meaningful correlations were observed between performance and any psychometric parameters. Discussion and conclusionA brief and intensive training regimen utilizing 3D virtual reality simulators enhances residents' microsurgical proficiency in brain tumour removal models. Simulators emerge as a viable tool to expedite the learning curve of in-training neurosurgeons.

The impact of cycling exercise on motor and functional recovery of patients in acute and subacute stroke phase

Introduction/Objective. Neurological impairment and immobility in stroke patients can lead to numerous complications. This study aimed to evaluate the effect of cycling exercises with visual feedback combined with conventional rehabilitation on neurological and motor recovery, balance, walking speed and endurance, and activities of daily living (ADL) in patients after acute and subacute stroke. Methods. A randomized prospective controlled trial was applied to this research. One hundred and twenty-seven hemiplegic stroke patients who received in-hospital rehabilitation were randomly assigned into two groups. Both groups received conventional rehabilitation treatment. The experimental group had an extra 30 minutes of cycling exercises for the upper and lower extremities on a stationary ergocycle MOTOmed muvi. Both groups? neurological status, upper and lower limb function, independence in ADL, balance, walking speed, and endurance were observed before and after the rehabilitation treatment. Outcome measures used were the National Institute of Health Stroke Scale (NIHSS), the modified Ashworth scale (MAS), the Brunnstrom Motor Evaluation Scale (BMES), upper and lower Fugl-Meyer assessment (FMA), the Barthel index (BI), the Berg Balance Scale (BBS), the six-minute walk test (6MWT) and the Timed Up and Go test (TUG). Results. The neurological recovery on the NIHSS scale, spasticity of the knee extensor measured by the MAS, the BMES and FMA-LE subscale for the affected leg, and the 6MWT presented more significant improvement in the experimental group than in the control group after the treatment (p &lt; 0.05 for all three analyses). Conclusion. Cycling exercises with visual feedback combined with conventional rehabilitation could promote neurological recovery and improve the motor function of the affected leg and walking speed in patients recuperating after acute and subacute stroke.

CURATE.AI—Artificial Intelligence‐Derived Personalized Tacrolimus Dosing for Pediatric Liver Transplant: A Retrospective Study

AbstractTacrolimus is the cornerstone of immunosuppressive therapy after pediatric liver transplantation. However, reliance on the physician's experience for dose titration, coupled with tacrolimus's narrow therapeutic window and inter‐ and intrapatient variability, often results in frequent under or overdosing events with detrimental patient outcomes. Existing predictive dose personalization models are not readily feasible for clinical implementation, as they require multiple measurements each day while the standard frequency is once daily. CURATE.AI, a small‐data artificial intelligence‐derived platform, is developed as a clinical decision support system to dynamically personalize doses using the patient's own data obtained once a day. Retrospective dose personalization with CURATE.AI on 16 patients’ data demonstrates potential to enable more patients to reach therapeutic range within the first week. The findings support the testing of CURATE.AI in a prospective controlled trial as an aid for the physician's decision on tacrolimus dose personalization after pediatric liver transplantation.

Complementary health education and clinical guidance for treating women experiencing infertility along with unexplained resistant hyperprolactinemia

This study prospective randomized controlled trial aims to test the impact of adding health education, awareness of some contributing factors and clinical guidance to therapeutic cabergoline given to infertile women with unexplained resistant hyperprolactinemia. It comprised 120 infertile women with unexplained persistent hyperprolactinemia not responding to therapeutic doses of cabergoline 1.5-2 mg/week who were subjected to proper history taking to exclude concomitant drug intake or possible brain problems in all cases. They were classified into group A (60 cases) who received health education and clinical guidance to search for possible contributing factors and were instructed to avoid them in addition to proper therapeutic doses of cabergoline, while group B (60 cases) received proper therapeutic doses of cabergoline only without clinical guidance. After 1 month, serum prolactin (PRL) was measured for all cases. All cases had high PRL level at the start of the study (79.9±28.4 [39-195] and 78.2±19.9 [42-189] in group A and B, respectively) without any significant difference. Pretreatment counselling revealed that lifestyle factors, sexual behaviors or feeding habits may contribute to resistant hyperprolactinemia in all cases without a significant difference between both groups. Serum PRL dropped significantly more in group A (20.14±10.31 [11-45] vs. 49.32±37.03 [12-100]) after combined health education, clinical guidance of the couple and proper treatment. It is concluded that lifestyle factors, sexual behaviors, and feeding habits would affect the response of hyperprolactinemia to treatment. Health education and clinical guidance with some advice to avoid them, would concomitantly improve the response of resistant hyperprolactinemia to therapeutic doses of dopamine agonists.

Immediate Unprotected Weightbearing vs 2 Weeks Nonweightbearing After Open Reduction Internal Fixation of Ankle Fractures.

Postoperative care protocols for ankle fracture surgery remain controversial with variability among care providers. This prospective controlled trial compared 12-week postoperative outcomes for immediate unprotected weightbearing (IMWB) vs nonweightbearing (NWB) for 2 weeks in a splint followed by weightbearing as tolerated (WBAT) in a boot after surgical fixation of selected low-energy ankle fractures without superior articular involvement. Eighty-seven patients undergoing surgical fixation of ankle fractures at a single level 1 trauma center were recruited according to specific criteria and enrolled by presentation date. The first 43 eligible patients were allocated to the control group, with NWB in a splint for 2 weeks followed by WBAT in a walker boot. The next 44 patients recruited were allocated to the IMWB group. The primary outcome was the Olerud-Molander score (OMAS). Secondary outcome measures included the Euroquol-5D (EQ5D) score and Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) scores, ankle range of motion (ROM), wound complications, time to return to work, radiograph measurements, and fracture reduction loss. In this perioperative-focused study, we collected data on patients until 12 weeks postoperation. The IMWB group had 5 superficial wound complications vs 1 in the control group. At 12 weeks, we found no difference in OMAS, EQ5D, WPAI:SHP scores, ROM, time to return to work, or radiographic measurements. In this short-term and relatively small prospective trial, we found more wound complications among patients treated with immediate unprotected weightbearing compared with patients treated with 2 weeks of NWB followed by protected weightbearing. Given the low incidence and small sample size, we do not know if these observed findings are generalizable. However, we also found no difference in functional outcomes at 12 weeks postoperation between these 2 groups. In light of that, we do not recommend IMWB after open reduction internal fixation of low-energy ankle fractures with plate and/or screw fixation. Level II, prospective controlled trial.

Effect of Teneligliptin in comparison with Voglibose as an add on therapy in reducing microvascular complications in type II Diabetes Mellitus patients – A Prospective randomized control trial

Background: The strict glycaemic control postpones all the microvascular and macrovascular complications. In type 2 diabetes the initiation of metformin is the cornerstone in reducing blood sugar. The next option is either insulin or oral hypoglycaemic agents. The DPP-4 inhibitors like gliptins have the advantages of less incidence of hypoglycaemia, good safety profile and can be combined to any oral hypoglycaemics. The meta-analysis showed that teneligliptin has less adverse profile in number of Japanese and Korean studies. It was proved that the fasting glucose and postprandial glucose substantially reduced with a potential benefit of reducing cholesterol, thereby reducing the risk of cardiovascular diseases. The advantage of using this drug as is does not worsen the hepatic and renal status. Voglibose an α-glycosidase inhibitors delay the glucose absorption from GIT hence effective in reducing postprandial hyperglycaemia. Methods: This prospective randomized controlled study was designed to compare the efficacy of teneligliptin and voglibose as an add on therapy on patients with uncontrolled blood sugar in addition to metformin 500mg BD and glimepiride 2 mg OD. Totally 80 patients were included between the age groups of 40 to 70 years. Patients were divided into two groups 40 patients each, group A were given teneligliptin and group B patients were given voglibose for a period of 6 months. At the end of 3rd month and 6th month investigations were done for FBS, PPBS and HbA1c.Statisticalmethods: Data were tabulated and results were analysed by using Analysis of Variance. AP value of &lt;0.05 was considered as statistically significant. Results: At the end ofsix months group II showed significant reduction in fasting blood sugar and post-prandial blood sugar level. A significant reduction in FBS, PPBS, HbA1c is seen in both the groups, where teneligliptin has a favourable glucose reduction along with voglibose. Conclusions: Our study concludes that teneligliptin is better than voglibose as the 2nd line add on therapy to sulphonylureas, metformin or insulin.

Analgesia in Transcutaneous Laryngeal Botulinum Toxin Injections: A Randomized Crossover Trial.

There is an absence of data in the literature regarding methods to improve the patient experience during the performance of awake in-office laryngeal injections. This study sought to evaluate whether the use of local anesthetic or a vibrating instrument decreased overall pain experienced by patients with laryngeal dystonia, frequently referred to as spasmodic dysphonia (SD), undergoing transcervical botulinum toxin injections. This was an unblinded, prospective randomized control trial with a crossover design where each patient received transcutaneous transcricothyroid injection of botulinum toxin with alternating use of no anesthesia, local anesthesia (2% lidocaine in 1:100,000 epinephrine), and vibrating instrument in three consecutive laryngeal injections to treat adductor SD. Patients were randomized to the order they received these treatments. Patients measured pain on a 0-10 visual analogue scale (VAS) and selected their preferred technique after receiving all three analgesic modalities. Thirty-two patients completed the study. There was no statistically significant difference in pain between the three analgesic techniques (p = 0.38). The most preferred analgesic technique was the vibrating wand (44% (14/32)). Lidocaine was the second most preferred (37% (12/32)) and 19% (6/32) of patients preferred nothing. When combining the wand and nothing groups, 63% of patients preferred one of these two methods (95% exact CI: 44%-79%). There was no statistically significant difference in median pain experienced by patients during laryngeal botulinum toxin injection between these different analgesic modalities. More than half of the patients selected a preference for a technique that did not include lidocaine. This data supports individualization of analgesia during transcutaneous laryngeal injections. 2 Laryngoscope, 134:2277-2281, 2024.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

OFFSPRING: A SPRING Follow-Up Study Assessing the Efficacy of Maternal Probiotics and Allergic Disease in the Child

Introduction: There are a variety of factors that contribute to the development of allergic diseases in children, including environmental exposures during the maternal prenatal period. It has been proposed that probiotic supplementation during pregnancy could be used as a possible preventative measure to target childhood allergic disease. Methods: Participants from a previously conducted prospective double-blind randomised control trial of probiotics versus placebo study (Study of PRrobiotics IN Gestation) were sent electronic questionnaires to complete about their child, who are now between 3 and 7 years of age. Demographic data and rates of allergic diseases were compared between the two groups. Results: One hundred and seven women responded to the questionnaires. Between the two groups, there was no difference in the frequency of allergic diseases, with similar rates of eczema, asthma, and hospital presentations seen. Conclusion: In this follow-up study, infants of mothers who were exposed to probiotics during their pregnancy do not appear to have any paediatric health advantages in terms of allergic diseases.

Effects of a Healthy Diet on Reducing Symptoms of Premenstrual Syndrome and Improving Quality of Life among Omani Adolescents: A Randomized Controlled Open-Label Trial.

Premenstrual syndrome (PMS) continues to impact the health outcomes and emotional well-being of reproductive-age women, globally. Several studies have provided conflicting evidence concerning the role of dietary approaches in improving PMS symptoms. Accordingly, this study aimed to evaluate the possible influence of a healthy diet and motivational strategies on PMS symptoms and health-related quality of life among Omani adolescents. This open-label, randomized, prospective controlled trial was conducted at two randomly selected secondary schools, in Al Seeb Willayah, in Muscat region. Adolescents with PMS symptoms, who were in grade 10 or 11, aged 16 years or above, had regular menstrual cycles, and were not known to have psychiatric disorder were included in this study. Participants in the intervention group received an individual face-to-face dietary consultation and motivational phone consultation. The health outcomes, including the PMS symptoms in both groups, and quality of life, were recorded using the Daily Record of Severity of Problems questionnaire (DRSP) and the 14-item Self-Reporting-Based Perceived Stress Scale tools, respectively. The primary outcome was the difference in the mean premenstrual symptom scores between the two groups. Secondary outcomes included the quality of life and stress levels of participants. The study period was from 1 February and ended 30 June 2021. SPSS was used to analyze the data, and intention-to-treat analysis was utilized. A total of 72 adolescents with PMS were randomized into intervention and control groups (n = 36 each). Both groups were similar at baseline (p-value > 0.05). No significant association was found between a healthy diet and PMS symptoms (p-value > 0.05). In addition, no significant association was found between a healthy diet and quality of life at follow-up (p-value = 0.216). The outcomes of this study refuted any possible relationships between a healthy diet and PMS symptoms. Accordingly, dietary consultations may not facilitate the clinical management of PMS symptoms in adolescent females.