Prospective Controlled Trial Research Articles

Nipple-Areolar complex sensory recovery based on incision placement after Nipple-Sparing mastectomy; a prospective Non-randomized controlled trial

Nipple-Areolar complex sensory recovery based on incision placement after Nipple-Sparing mastectomy; a prospective Non-randomized controlled trial

Field therapies for actinic keratosis: an Australian cost‐effectiveness analysis

AbstractBackgroundActinic keratoses have a high prevalence in the older Australian population, with most patients presenting with field actinic damage. Despite this high prevalence, no field therapies are subsidised under the Pharmaceutical Benefits Scheme.ObjectivesTo determine which therapy for field actinic damage is the most cost‐effective when comparing 5‐fluorouracil (5‐FU), imiquimod (IMQ), and methyl‐aminolevulinate photodynamic therapy (MAL‐PDT) at 12 months post‐treatment.MethodsA decision tree was constructed using TreeAge Pro, representing the likely clinical trajectories of patients with field actinic damage treated with 5‐FU, IMQ, and MAL‐PDT. The cost‐effectiveness analysis was performed from the patient perspective, assuming an outpatient setting. Efficacy data was derived from a single‐blinded, multi‐centre prospective randomised control trial. Cost data were derived from Australian dermatology clinics and pharmacies. One‐way and probabilistic sensitivity analyses were conducted.Results5‐FU was the most cost‐effective treatment. It was cheaper and more effective than all other treatments, with a cost‐effectiveness ratio of AU$201 per patient achieving ≥75% clearance in field actinic damage. The cost‐effectiveness ratios of IMQ, and MAL‐PDT were AU$940, and AU$8058 per patient achieving ≥75% clearance respectively. Both sensitivity analyses showed certainty in 5‐FU's dominance over the other treatments.Conclusions5‐FU is the most cost‐effective treatment option for Australian patients presenting with actinic field damage on the head area.

Identification and Categorization of Technical Errors and Hazard-zones of Robotic versus Laparoscopic total Gastrectomy for Gastric Cancer: A Single Center Prospective Randomized Controlled Study.

The current research aimed to conduct a detailed analysis of intraoperative surgical performance, short-term outcomes, identify and categorize technical errors, and hazard-zones enacted during total gastrectomy performed robotically and laparoscopically by surgeons. Prospective research is needed to determine whether the technical advantages of robotic surgery translate to patient outcomes. Identify and process risk areas in robot-assisted total gastrectomy (RTG) and laparoscopic total gastrectomy (LTG) to get the best patient results. Patients undergoing RTG and LTG were recruited and randomized into the study. Six consultant/attending surgeons participated in this study and all surgical procedures were recorded. The unedited surgical video-recordings were handed over to third-party experts for granular analysis of the procedures using objective clinical human reliability analysis (OC-HRA) for the quality of intraoperative performance, technical errors, intraoperative complications. This study is a single center prospective randomized controlled trial. 82 patients were recruited and participated in this study with 40 cases undergoing RTG and 42 cases for LTG. RTG vs LTG. Determine whether RTG or LTG can provide the better intraoperative technical performance and identify the most hazardous zone (area) during total gastrectomy (TG). The technical errors enacted and identified in the RTG and the LTG were (46.11±5.63 VS 58.79±8.45, P＜0.001) respectively. The highest number of technical errors was identified during the dissection of the supra-pancreatic lymph nodes (Task Zones3, TZ3), including No.5, 7, 8a, 9, 11p, and 12a to complete the nodal clearance around the celiac artery and its trifurcation (7.29±1.88 VS 9.43±2.24, P <0.001) in both RTG and LTG. The number of lymph nodes harvested with RTG was higher than LTG (35.36±7.51 VS 30.54±6.95, P=0.016), especially in the upper margin of the pancreas (13.32±4.17 VS 9.36±3.81, P＜0.001). The total cost of hospitalization in the RTG group cost 3% more than LTG group ($15953.41±3533.91 VS $12198.26±2761.27, P＜0.001). This study offers compelling OC-HRA evidence demonstrating that RTG facilitates significantly superior technical performance compared to LTG. Whether examining short-term clinical outcomes or intraoperative operations, the robotic surgery system consistently outperforms laparoscopic surgery. Lymph node dissection in the supra-pancreatic region emerged as a major hazard zone in both procedures. chictr.org.cn: ChiCTR2000039193.

Long-term effects of metformin on fat depots and insulin-glucose parameters in patients with prediabetes and chronic heart failure

Introduction. Chronic heart failure with preserved ejection fraction (CHpEF) is a heterogeneous syndrome with a variety of pathophysiological factors, including obesity and impaired carbohydrate metabolism associated with an increase in visceral adipose tissue. Due to the positive effect of metformin on weight loss, in recent years special attention has been paid to its effect on fat depots.Aim. To study the effects of metformin XR after 12 months of administration on various fat depots and glucose metabolism parameters in patients with CHpEF, prediabetes and abdominal obesity (AO).Materials and methods. A single-center open-label randomized prospective controlled trial included 64 people (50% men, median age 58 [55.25; 59.75] years) with CHpEF, prediabetes and AO. All patients (groups A and B) received optimal CHpEF therapy. In group A (n = 32), metformin XR 1000–1500 mg/day was additionally prescribed. All patients underwent general clinical examination, calculation of insulin resistance indices, ultrasound lipometry with determination of the size of epicardial, preperitoneal and subcutaneous fat, in addition, the thickness of epicardial fat was assessed using magnetic resonance imaging (MRI) of the heart.Results. In group A, after 12 months of the study, fasting plasma glucose levels decreased from baseline by 7.7% (p &lt; 0.0001), glycated hemoglobin by 3.3% (p = 0.008), fasting insulin by 20% (p = 0.004) and HOMA-IR and FIRI indices by 25.3% (p = 0.001). In the control group, on the contrary, the values of glycated hemoglobin increased by 3.4% (p = 0.021), fasting insulin by 45% (p = 0.031), HOMA-IR and FIRI by 52.4% (p = 0.020). In group A, the thickness of epicardial fat decreased by 6.1% (p = 0.020) according to ultrasound and MRI lipometry by 16.7% (p = 0.029), preperitoneal fat by 3.0% (p = 0.009), subcutaneous fat by 11.2% (p = 0.001).Conclusion. Metformin XR therapy for 12 months in patients with prediabetes, CHpEF and AO against the background of optimal basic CHpEF therapy had a beneficial effect on glucose metabolism (decrease in fasting plasma glucose and insulin, glycated hemoglobin, insulin resistance indices HOMA-IR, FIRI) and on subcutaneous and visceral adipose tissue depots: epicardial and preperitoneal.

Efficacy and safety of ciprofol for general anesthesia induction in female patients with frailty: a prospective randomized controlled trial

BackgroundCiprofol, a recently developed anesthetic agent, is not inferior to propofol in terms of efficacy and safety. However, most previous clinical experience with ciprofol was based on a robust population. This study aimed to investigate the efficacy and safety of ciprofol for anesthesia induction in female patients with frailty.MethodsThis prospective randomized controlled trial included patients with frailty undergoing elective general anesthesia for gynecological surgery. Frailty was assessed using the modified frailty index. The patients were randomly administered propofol (2 mg/kg) or ciprofol (0.5 mg/kg) during anesthesia induction. The depth of anaesthesia was continually monitored by the bispectral index. The primary outcome was the lowest systolic blood pressure (SBP) during anesthesia induction. Secondary outcomes included the incidence of general anesthesia induction failure and adverse events.ResultsAmong the 69 enrolled patients with frailty, 67 were included in the final analysis. The success rate of anesthesia induction was 100% in both groups. The lowest SBP was significantly higher in the ciprofol group than in the propofol group (103 [96–110] vs. 90 [85–98] mmHg, respectively; P < 0.001), suggesting that the former caused less inhibition of hemodynamics during anesthesia induction in patients with frailty. The incidence of injection pain was lower in the ciprofol group than in the propofol group (3 [8.8%] vs. 11 patients [33.3%], respectively; P = 0.014).ConclusionsThe results of this study suggest that the efficacy of ciprofol for inducing general anesthesia in patients with frailty is comparable to that of propofol, with more stable hemodynamics.Trial registrationThe trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry (www.chictr.org.cn) (Clinical trial number: ChiCTR2300075271; https://www.chictr.org.cn/showproj.html?proj=205160, principal investigator’s name: Zifeng Xu, date of registration: 31/08/2023).

A Moving Target: Studying the Effect of Continuous Transcutaneous CO2 Monitoring in ELBW Infants During an Equipoise Shift.

Objectives: To assess whether continuous non-invasive pCO2 monitoring by transcutaneous pCO2 monitor (TCpCO2) among extremely low birth weight (ELBW) premature infants, during the first week of life, will decrease the rate of high-grade intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) or the combined outcome of IVH/PVL and death. Methods: This was a prospective, observational, multicenter study. Due to ethical constraints, allocation was based on TCpCO2 monitor availability. ELBW infants were either monitored by TCpCO2 monitor (Sentec, Therwil, Switzerland) (study group), or recruited to the control group if a TCpCO2 monitor was not available. Results: A total of 132 ELBW infants participated in the study. The size of the study group (106 infants) and the control group (26 infants) differed because monitor availability increased during the study period reflecting change in standard of care. The groups had comparable gestational age and baseline characteristics. No difference was found in the rate of IVH/PVL in the study vs. control groups (10% vs. 4%; p = 0.7, respectively), or in the combined outcome of PVL/IVH and death (16% vs. 15%; p = 1.0, respectively). Conclusions: This study demonstrates the challenges in conducting a prospective controlled trial in a rapidly evolving medical field. While the study began with a clear equipoise, this balance shifted as the care team gained more experience with TCpCO2 monitoring among the study population, despite the absence of new clinical evidence to justify such a shift. Consequently, the small control group limited our ability to draw definitive conclusions regarding the study's objective. However, our findings may increase awareness of continuous non-invasive pCO2 monitoring in extremely premature infants.

Feasibility Trial of an Online Expressive Writing Intervention for Young Adult Cancer Survivors.

Purpose: Many young adult (YA) breast cancer survivors (BCS) experience psychosocial distress during and after treatment, but do not utilize supportive care resources to maximize their health outcomes. The purpose of this pilot study was to test the feasibility and acceptability of a brief, internet-based expressive writing (EW) intervention intended to improve psychosocial health among YA BCS. Methods: Thirty YA BCS were remotely recruited via a hospital patient database and randomly assigned to the EW (n = 20) or neutral writing (n = 10) group. The EW intervention included delivery of positive messages and a weekly 30-minute EW activity for 3 weeks. Feasibility, acceptability, patient-reported satisfaction, and health outcomes were evaluated at baseline and 1-month follow-up. Results: The database-focused recruitment strategies (40% response) appeared to be feasible. Almost all (93%) participants adhered to at least one writing task and 67% to at least two writing tasks. Participants perceived the study as enjoyable and helpful for reducing stress. The difference in QOL of the intervention versus control group was medium to large (d = 0.73). Conclusion: This is the first study to test the feasibility of an internet-based EW for YA BCS. The online EW pilot intervention demonstrated evidence of feasibility and acceptability to YA BCS; its potential to improve health outcomes should be evaluated in an adequately powered prospective randomized controlled trial (RCT). Online EW may be offered to YA BCS in low-resource settings to address their unique physical and psychological challenges.

Efficacy and Complications of Full Dose versus Half Dose of Botulinum Toxin Type A Injection in Benign Essential Blepharospasm

Objective: To compare the effectiveness, patient satisfaction, and complications associated with pretarsal botulinum toxin type A (BTX-A) injections using half versus full doses of benign essential blepharospasm (BEB). Materials and Methods: A prospective double-masked randomized control trial was conducted in 20 patients. Each patient was randomized to receive either 40 or 80 units of BTX-A injections at Thammasat Hospital between April 2022 and August 2023. The primary outcome measures were frequency and severity using the Jankovic Rating Scale (JRS), latency to response, self-response scale, and patient satisfaction scale at four weeks and 12 weeks post-injection. The secondary outcome measures were complications of injection in each visit. Results: There were no significant differences between the groups receiving half-dose and full-dose BTX-A injections in the self-response scale at 2.60±0.52 versus 2.00±1.15, (p=0.277), patient satisfaction scale at 8.30±1.57 versus 7.00±1.49, (p=0.063) at four weeks and JRS frequency at 1.00±0.82 versus 1.20±0.92, (p=0.687), JRS severity at 1.30±1.16 versus 1.40±0.97, (p=0.784), latency to response at 5.80±1.99 versus 6.80±1.93, (p=0.214), self-response scale at 2.70±0.48 versus 2.20±0.63, (p=0.067), and patient satisfaction scale at 8.10±1.60 versus 8.30±1.49, (p=0.776) at 12 weeks. Complications, including epiphora, dry eye, and lagophthalmos, were observed in both groups. Conclusion: The present study indicated no significant differences between half-dose and full-dose BTX-A injections. Either dose showed comparable efficacy and safety in treating BEB. Trial registration: The present study protocol was registered at the Thai Clinical Trials Registry (TCTR20240320002; date March 20, 2024).

Outcomes at mean follow-up of four years following AO type-C distal humerus fractures managed with fixation or arthroplasty.

To compare outcomes between open reduction internal fixation (ORIF), total elbow replacement (TER) and distal humerus hemiarthroplasty (DHH) for AO type-C (AOC) fractures of the distal humerus in patients aged 50 years or older. A retrospective analysis of acute AOC distal humerus fractures in patients aged 50 years or older between 2016 and 2022. Outcomes measured: Oxford Elbow Score (OES), Mayo Elbow Performance Score (MEPS), complication rate, re-operation rate and range of movement (ROM). Sixty-five patients met the inclusion criteria (20 males, 45 females). Mean age was 64.4, 77.1 and 61.3 years old for ORIF, TER and DHH respectively. Logistic model analysis revealed a statistically significant increased complication rate in the ORIF group compared to the TER and DHH groups (ORIF vs TER p = 0.01; ORIF vs DHH p = 0.048). There was a higher re-operation rate in the ORIF group compared to the DHH group (p = 0.03). There were no differences in OES, MEPS or ROM between groups. This supports the use of TER in elderly patients with AOC distal humerus fractures. In the younger patient, DHH may have lower rates of complications and re-operations compared to ORIF, but function remains similar. We propose a prospective randomised control trial.

Is the phoenix sign phenomenon due to vasodilation? A double-blinded, randomized controlled trial comparing motor function recovery after diagnostic common fibular nerve block with lidocaine and papaverine

BackgroundFocal entrapment of the common fibular (peroneal) nerve (CFN) is the most common nerve entrapment in the lower extremity. Accurate diagnosis can be difficult due to co-existent pathology such as low back pathology. A 1% lidocaine block of CFN is often used to confirm the local entrapment pathology and demonstrate possibility of pain relief. A surprising, unexpected and temporary strengthening of CFN supplied ankle and foot muscles is occasionally produced, termed the Phoenix sign. Aetiology of this phenomenon has been puzzling, but restoration of neural circulation and nutrition via improved local blood flow has been postulated to be responsible.MethodsThis is a double-blinded, randomized, prospective controlled trial of 20 patients, comparing 2 vasodilating agents and their ability to produce the Phoenix effect. Ultrasound guided infiltration of 0.3 mL 1% lidocaine or papaverine HCl 10 mg/mL was executed adjacent to CFN. Motor strength pre- infiltration and 4 min post-infiltration were measured for anterior compartment muscles utilizing MRC manual motor testing reported on a 0–5 scale. The extensor hallucis longus (EHL) muscle proved to be the most significant.ResultsAverage motor strength of the EHL improved from 2.2 (+/-0.40) to 4.9 (+/-0.32).) in the lidocaine group. In the papaverine group, pre-infiltration EHL motor strength averaging 2.1 (+/-0.93) improved to 4.4 (+/- 1.01) post-infiltration. Papaverine and lidocaine produced similar statistically significant increases in muscle strength (p = < 0.05).ConclusionThere was no difference between small local infiltrations of lidocaine or papaverine in production of increased anterior compartment EHL motor strength. It is most likely that the Phoenix Effect is explained by temporary local improvements in the microcirculation of the CFN vasa nervorum.Trial RegistrationNCT06637046 10/10/2024 Retrospectively registered.

Implementation and outcomes of an enhanced recovery after surgery pathway for laparoscopic cholecystectomy in East and Central Africa: A prospective non-randomized controlled trial in Rwanda's Tertiary Teaching Hospital.

Enhanced recovery after surgery (ERAS) programs have demonstrated efficacy in optimizing perioperative care and improving patient outcomes in various surgeries. However, their implementation and outcomes in resource-limited settings remain underexplored. This study aimed to assess the implementation of an ERAS protocol for laparoscopic cholecystectomy in such a setting. This prospective non-randomized controlled trial involved 100 patients undergoing laparoscopic cholecystectomy at the University Teaching Hospital of Kigali, Rwanda. The first 50 patients on the ERAS pathway were prospectively evaluated and retrospectively compared to the last 50 patients operated on before ERAS implementation. Data on demographics, preoperative information, intraoperative compliance, postoperative events, and patient feedback were collected and analyzed. ERAS implementation resulted in a significant reduction in hospital length of stay (LOS) (p<0.001) without increase in complications. Compliance with ERAS principles, including preoperative education and perioperative management, was more than 90%. ERAS also reduced costs due to quicker recovery and shorter hospital LOS. The implementation of ERAS for laparoscopic cholecystectomy in a limited-resource setting is feasible and safe, suggesting the possibility of its potential adoption in other abdominal procedures. A high level of adherence to the ERAS pathway can be achieved with effective patient education and the dedication of healthcare providers.

Utilization of NIRS Monitor to Compare the Regional Cerebral Oxygen Saturation Between Dexmedetomidine and Propofol Sedation in Mechanically Ventilated Critically ill Patients with Sepsis- A Prospective Randomized Control Trial.

Delirium frequently occurs in the acute phase of sepsis and is associated with increased ICU and hospital length of stay, duration of mechanical ventilation, and higher mortality rates. We utilized the Near-Infrared Spectroscopy monitor to measure and compare the regional cerebral oxygen saturation in mechanically ventilated patients of sepsis receiving either dexmedetomidine or propofol sedation and assessed the association between delirium and regional cerebral oxygen saturation. A single center prospective randomized control trial conducted over a period of two years, 54 patients were included, equally divided between propofol and dexmedetomidine groups. Patients received a blinded study drug, propofol (10 mg/mL) or dexmedetomidine (5 mcg/mL) via infusion pump according to randomization. Infusion rates were adjusted every 10 min based on weight-based titration tables, aiming for target sedation (RASS -2 to 0). Management components included pain monitoring using the CPOT score and delirium assessment using CAM-ICU score. Dexmedetomidine group showed higher mean regional cerebral oxygen saturation as compared to propofol group (P = .036). No significant differences were found in mechanical ventilation or ICU stay durations, delirium-free days, or sedation cessation reasons. Delirium occurred in 36 patients, with lower mean regional cerebral oxygen saturation as compared to non-delirious patients. The dexmedetomidine group had higher regional cerebral oxygen saturation compared to the propofol group. Delirious patients showed lower cerebral oxygen saturation than non-delirious patients, suggesting a link between sedation type, cerebral oxygenation, and delirium.CTRI registration: REF/2021/11/048655 N.

Robotic-Assisted Navigation in Single-Level Transforaminal Lumbar Interbody Fusion Reduces Surgeons’ Mental Workload Compared With Fluoroscopic and Computed Tomographic Techniques: A Nonrandomized Prospective Controlled Trial

Background: Pedicle screw placement during spine fusion is physically and mentally demanding for surgeons. Consequently, spine surgeons can become fatigued, which has implications for both patient safety and surgeon well-being. Purpose: We sought to assess the cognitive workload of surgeons placing pedicle screws using robotic-assisted navigation compared with fluoroscopic and computed tomography (CT)-assisted placement. Methods: We performed a nonrandomized prospective controlled trial to compare the cognitive workload of 3 surgeons performing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) using robotic, CT, or fluoroscopic navigation on 25 patients (15 in the robotic navigation group and 10 in the nonrobotic group). Immediately after each procedure, surgeons submitted the National Aeronautics and Space Administration–Task Load Index (NASA-TLX), which has 6 subscales: mental demands, physical demands, temporal demands, performance, effort, and frustration. Four tasks associated with pedicle screw placement were assessed independently: (1) screw planning, (2) calibrating robot/obtaining imaging/registration, (3) pedicle cannulation, and (4) screw placement. Patient demographics and surgical characteristics were obtained and reviewed. Results: Surgeons’ self-reported cognitive workload was significantly reduced when using robotic-assisted navigation versus CT/fluoroscopic navigation. Workload was reduced for screw planning, pedicle cannulation, and screw placement. In addition, there were significant reductions in each subdomain for these 3 tasks, encompassing mental demand, physical demand, temporal demand, effort, and frustration with improved task performance. Conclusions: This study found significant reductions in mental workload with improved perceived performance for robotic-assisted pedicle screw placement compared with fluoroscopic and CT-navigation techniques. Lowering the cognitive burden associated with screw placement may allow surgeons to address the remainder of the operative case with less decision fatigue, prevent complications, and increase surgeon wellness.

Evaluation of patients with central retinal vein occlusion using optical coherence tomography angiography

Background Retinal vein occlusion (RVO) is the second most prevalent retinal vascular disorder after diabetic retinopathy, it may be categorized as central, hemi-central, and branch RVO. The most important risk factors are hypertension, diabetes mellitus, and hyperlipidaemia. Aim The objective of the research is to assess the ocular condition of patients with central retinal vein occlusion (CRVO) using optical coherence tomography angiography (OCT-A). Patient and methods This prospective cross-sectional controlled trial was conducted on a total of 44 individuals, who were separated into two distinct groups: group 1: 24 eyes of 24 patients with central RVO, group 2: 20 eyes of 20 healthy persons. Results Foveal avascular zone (FAZ) was significantly larger in both superficial and deep plexi levels in CRVO cases in comparison to the values of the same levels in normal subjects with predominance FAZ enlargement in the deep plexus than superficial plexus. Measurement of vascular density was significantly less in both superficial and deep plexi levels in CRVO cases in comparison to the same levels in normal subjects. Central macular thickness (CMT) detected by OCT was significantly more in CRVO cases in comparison to normal subjects. There were negative correlation between best-corrected visual acuity in decimal and CMT, Increased CMT was associated with diminish best-corrected visual acuity. Conclusion OCTA has the advantage of being a non-invasive method in assessing CRVO patients which makes it more practical than FFA in some clinical situations like patients with chronic kidney disease.

Adults who Smoke Should Have Pulmonary Function Testing Before and After Coronary Artery Bypass Grafting (CABG)

Background: Recent research has shown that coronary artery bypass grafting (CABG) has a mortality rate of 0.6–3.0%, making it a popular and generally safe cardiac operation. The purpose of this study is to examine the relationship between sex, age, and diabetes in the early changes in lung volumes measured by pulmonary function tests before and after coronary artery bypass grafting (CABG) in individuals who smoke. Subjects and procedures: Elective coronary artery bypass surgery was the procedure of choice for 200 consecutive patients in this prospective controlled trial. Participants who were not part of the trial were those who were in an emergency or who had a valve operation done alongside a CABG procedure. Based on the data from the operation, the cardiopulmonary bypass time was 98.89 minutes with a standard deviation of 25.14 minutes. The average time for cardiac ischemia was 67.8 minutes with a standard deviation of 26.6 minutes and a range of 25 to 227 minutes. The total time spent in the intensive care unit was 53.54 hours with a standard deviation of 27.98 hours and a range of 4 to 102 hours. Thirteen patients, or 6.5%, were cold, while the remaining patients were warm. Thirteen patients, or 6.5%, used ice slush as a topical cooling method. The results of the pulmonary function tests taken before and after surgery were significantly different. Conclusion: Postoperative obstructive and restrictive breathing problems are associated with cigarette smoking's detrimental effects on pulmonary functioning. Patients with a smoking history who are scheduled for elective revascularization surgery should have their pulmonary status evaluated before surgery, and they should be strongly encouraged to quit smoking as soon as possible before surgery to minimize the risk of respiratory complications after surgery.

Open versus robotic retromuscular ventral hernia repair: outcomes of the ORREO prospective randomized controlled trial.

Robotic retromuscular ventral hernia repair (rRMVHR) potentially combines the best features of open and minimally invasive VHR: myofascial release with abdominal wall reconstruction (AWR) with the lower wound morbidity of laparoscopic VHR. Proliferation of this technique has outpaced the data supporting this claim. We report 2-year outcomes of the first randomized controlled trial of oRMVHR vs rRMVHR. Single-center randomized control trial of open vs rRMVHR. 100 patients were randomized (50 open, 50 robotic). We included patients > 18 y/o with hernias 7-15cm with at least one of the following: diabetes, chronic obstructive pulmonary disease (COPD), body mass index (BMI) ≥ 30, or current smokers. Primary outcome was occurrence of a composite outcome of surgical site infection (SSI), non-seroma surgical site occurrence (SSO), readmission, or hernia recurrence. Secondary outcomes were length of stay, any SSI or SSO, SSI/SSOPI, operative time, patient reported quality of life, and cost. Analysis was performed in an intention-to-treat fashion. Study was funded by a grant from Society of American Gastrointestinal and Endoscopic Surgeons. 90 patients were available for 30-day and 62 for 2-year analysis (rRMVHR = 46 and 32, oRMVHR = 44 and 30). Hernias in the open group were slightly larger (10 vs 8cm, p = 0.024) and more likely to have prior mesh (36.4 vs 15.2%; p = 0.030), but were similar in length, prior hernia repairs, mesh use, and myofascial release. There was no difference in primary composite outcome between oRMVHR and rRMVHR (20.5 vs 19.6%, p = 1.000). Median length of stay was shorter for rRMVHR (1 vs 2days; p < 0.001). All patients had significant improvement in quality of life at 1 and 2years. Other secondary outcomes were similar. There is no difference in a composite outcome including SSI, SSOPI, readmission, and hernia recurrence between open and robotic RMVHR.

A Prospective Randomized Control Trial of Lingual Frenuloplasty with Myofunctional Therapy in Patients with Maxillofacial Deformity in a Polish Cohort.

Introduction: There are few publications concerning ankyloglossia in mixed-aged groups utilizing myofunctional therapy and frenuloplasty in patients undergoing orthodontic treatment and maxillofacial surgery. While it is well known that ankyloglossia is mainly diagnosed in babies, research on functional and structural disorders in different age groups is less common. Thus, there is a high need for specific information about the influence and effectiveness of frenuloplasty with myofunctional therapy on the stomatognathic function and final treatment outcome for a wider variety of patients, especially those with maxillofacial deformities. Aim: This paper aims to evaluate the impact of lingual frenuloplasty as an adjunct to myofunctional therapy for the treatment of ankyloglossia in children and adults with maxillofacial deformity. Methods: Prospective randomized control trial with 155 subjects. Methods were based on visual observation and examination of the oral cavity. There were two groups: myofunctional therapy vs. myofunctional therapy and lingual frenuloplasty. Patients were randomized based on order of entry into the study. χ2 test, Kruskal-Wallis, ANOVA, Student's t-test and others were used for statistical analyses. Results: The presented protocol with myofunctional therapy and surgical procedures proved to be significantly more effective in improving tongue mobility and stomatognathic functions such as swallowing, breathing, and oral resting postures as compared to the reference group who underwent myofunctional therapy only. Conclusions: Lingual frenuloplasty with myofunctional therapy is highly effective in restoring the equilibrium of the orofacial muscles and the skeleton, which is often disturbed and may lead to unstable functional effects among patients considering orthodontic and orthognathic treatments for maxillofacial deformities.

968P HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors for advanced HCC with portal vein tumor thrombosis: A prospective controlled trial

968P HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors for advanced HCC with portal vein tumor thrombosis: A prospective controlled trial

The long-term efficacy and safety of balloon dilation eustachian tuboplasty combined with tympanostomy tube insertion for patients with otitis media with effusion: study protocol for a prospective randomized controlled trial

BackgroundOtitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure.Methods and analysisThis is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs).DiscussionThis is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial’s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy.Trial registrationChinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452.

Assessment of the Potential Role of Preoperative Dental Clearance in Total Joint Arthroplasty Optimization: A Pilot Study.

Periprosthetic joint infection (PJI) is a serious complication after total joint arthroplasty (TJA) and is associated with significant morbidity, mortality, and cost. This pilot study primarily aimed to investigate if preoperative dental screenings would impact the rate of PJI following TJA when compared to historical controls. Secondarily, this study aimed to evaluate the prevalence of dental pathology in patients undergoing TJA. Charts from 103 consecutive patients undergoing primary or revision total hip arthroplasty (THA, rTHA) or total knee arthroplasty (TKA, rTKA) by a single surgeon at a single academic institution over a two-year period were reviewed and selected for inclusion. All patients were referred to a dentist for preoperative clearance using a standardized form. The rate of dental pathology before surgery, details of the dental intervention required, and any dental work performed within six months postoperatively were evaluated. The demographic and comorbidity composition of our patient population was also collected. Finally, rates of PJI following each type of TJA were obtained for demographic- and comorbidity-matched historical controls from similar study designs to examine the potential impact of preoperative dental intervention. Of the 103 patients, 31 (30.1%) were found to have preoperative dental pathology. Twenty-eight of these 31 patients (90.3%) required dental intervention prior to surgery. Based on demographic- and comorbidity-matched historical data, we expected two (95% CI (0, 6)) PJI cases for the THA group, 0 (95% CI (0, 2)) PJI cases for the TKA group, two (95% CI (0, 5)) PJI cases for the rTHA group, and two (95% CI (0, 5)) PJI cases for the rTKA group. However, in our study, there were no PJIs after any TJA up to the latest follow-up, which was unlikely for THA, rTHA, and rTKA groups given the calculated Poisson probabilities (9.39%, 15.11%, and 11.26%, respectively). Finding 0 cases was likely for the TKA group given the calculated Poisson probability of 72.61%. This pilot study demonstrated that preoperative dental screening, which aims to decrease the chance of PJI due to bacteremia, may have an impact on the rate of PJI following THA, rTKA, and rTHA but not TKA based on Poisson probabilities calculated from demographic- and comorbidity-matched historical controls that lacked preoperative dental screening. For THA, rTKA, and rTHA, the Poisson probabilities of observing 0 cases of PJI postoperatively, as was the case in our study, were unlikely, suggesting that some variable in our cohort was decreasing the PJI rate for these groups. However, in the case of TKA, the Poisson probability of observing 0 cases was likely and matched the results of our study, suggesting that no variable in our cohort was affecting the PJI rate for this group. We cannot draw direct conclusions from this retrospective observational study, but the preliminary findings prompt further investigation through an appropriately controlled, blinded, multi-centered, and powered prospective randomized controlled trial.