Prospective Randomized Control Trial Research Articles

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.

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).

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.

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.

Safety and effectiveness of intraosseous regional prophylactic antibiotics in total knee arthroplasty: a systematic review and meta-analysis.

Intraosseous regional administration (IORA) as a widely applicable and clinically valuable route of administration has gained significant attention in the context of total knee arthroplasty (TKA) for the prophylactic administration of antibiotics. However, there is still controversy regarding its effectiveness and safety. The latest meta-analysis reports that the use of IORA for antibiotics in TKA is as safe and effective as IV administration in preventing prosthetic joint infection (PJI), but they did not separate the statistics for primary TKA and revision TKA, which may be inappropriate. There is currently a lack of evidence specifically comparing the outcomes of prophylactic antibiotic administration via IORA or IV route in primary/revision TKA, respectively, and new research evidence has emerged. In this study, we conducted a systematic review and meta-analysis with the primary objective of comparing the local drug tissue concentration and the incidence of PJI between preoperative IORA and intravenous (IV) administration of prophylactic antibiotics in TKA. Additionally, the occurrence of complications between the two administration routes was also compared. This meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement (PRISMA) guidelines. Retrospective cohort studies and prospective randomized controlled trials that utilized intraosseous local drug delivery for prophylactic antibiotics in knee arthroplasty were included. English literature from PubMed, Embase, and Cochrane Library databases was searched from the inception of each database until December 2023. Two researchers independently screened the literature, assessed the quality, and extracted data according to the inclusion criteria. The primary outcomes were local antibiotic tissue concentration and postoperative PJI incidence, while the secondary outcome was the occurrence of postoperative complications. Statistical analysis was performed using Review Manager 5.3 software. This study included 7 prospective randomized controlled trials and 5 retrospective cohort studies. A total of 4091 patients participated in the 12 included studies, with 1,801 cases receiving IORA and 2,290 cases in the control group. In terms of local drug tissue concentration, intraosseous infusion (IO) 500mg vancomycin significantly increased the drug concentration in the periarticular adipose tissue (SMD: 1.36; 95% CI: 0.87-1.84; P < 0.001; I2 = 0%) and bone tissue (SMD: 0.94; 95% CI: 0.49-1.40; P < 0.001; I2 = 0%) compared to IV 1g vancomycin. Regarding the incidence of postoperative PJI after primary TKA, IO 500mg vancomycin was more effective in reducing the occurrence of PJI compared to IV 1g vancomycin (OR: 0.19; 95% CI: 0.06-0.59; P < 0.001; I2 = 36%). Finally, no significant differences were found between the two groups in terms of postoperative pulmonary embolism (PE) (OR: 1.72; 95% CI: 0.22-13.69; P = 0.59; I2 = 0%) and vancomycin-related complications (OR: 0.54; 95% CI: 0.25-1.19; P = 0.44; I2 = 0%). Preoperative prophylactic antibiotic administration via IORA in TKA significantly increases local drug tissue concentration without significantly increasing systemic drug-related complications compared to traditional IV administration. In primary TKA, low-dose vancomycin via IORA is more effective in reducing the incidence of PJI compared to traditional IV regimens. However, its effectiveness remains controversial in high-risk populations for PJI, such as obese, diabetic, and renal insufficiency patients, as well as in revision TKA.

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.

A Comparison of Incisional Dressings and Negative-Pressure Wound Therapy for the Prevention of Infection and Wound Complications After Primary Total Hip and Knee Arthroplasty: A Network Meta-Analysis of Randomized Controlled Trials.

Incisional dressings may decrease wound complications and joint infection after total hip and knee arthroplasties (THA; TKA). However, there is no consensus on the superiority of a particular product. This study compared infection and wound complications among randomized controlled trials (RCTs) across various dressing types after primary THA and TKA. Scopus, Ovid/MEDLINE, PubMed, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials were queried in May 2024. A frequentist model network meta-analysis of eligible prospective RCTs compared minor and major wound complications and dressing changes using P-scores. Of 3,067 compiled studies, 12 RCTs of 1,939 patients with median (interquartile range) follow-up of 42 (382) days undergoing primary THA (n = 880, 45.4%) or TKA (n = 1,059, 54.6%) with alginate (n = 208; 10.7%), absorbent (n = 236; 12.2%), gauze (n = 474; 24.4%), or hydrofiber (n = 683; 35.2%) dressings or negative-pressure wound therapy (NPWT; n = 338; 17.4%) were included for meta-analysis. Compared with gauze, alginate and hydrofiber dressings were associated with fewer postoperative changes (mean difference [MD], -12.1; 95% confidence interval [CI], -15.08 to -9.09, p < 0.001; MD, -3.5; 95% CI, -6.30 to -0.74, p = 0.013, respectively). In a subanalysis, silver-ion hydrofiber also was associated with fewer changes (MD, -5.0; 95% CI, -5.70 to -4.39; p < 0.001). Overall, there was no statistically significant risk of increased minor nor major wound complications including superficial and deep infections among all dressing types and NPWT compared with gauze. Despite no association between wound complications nor infection risk among various incisional dressings and NPWT vs. gauze, the alginate, hydrofiber, and silver hydrofiber dressings had statistically fewer mean postoperative changes. Future studies are required to assess whether these dressings confer reduced infection risk. Therapeutic, Level I. See Instructions for Authors for a complete description of levels of evidence.

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.

Effects of Music Therapy on Postoperative Pain Perception in Patients Undergoing Abdominal Surgeries Under General Anesthesia: A Prospective Controlled Randomized Comparative Clinical Study.

Background Music therapy has been shown to reduce the need for sedation and analgesics, as well as lower plasma cortisol and epinephrine levels in patients undergoing regional anesthesia. This study evaluates the efficacy of perioperative music therapy in reducing pain perception and its impact on cortisol levels. Materials and methods This prospective randomized control trial was conducted at the tertiary care center in Western Maharashtra. Sixty adult patients (males/females) undergoing elective lower abdomen surgery were included and randomized equally into two groups to listen to music using headphones at a preselected volume (Group M) or to use only headphones without any music played (Group C) for 2 hours in the preoperative, intraoperative, and postoperative periods. Demographic information, anthropometric (height, weight), and biochemical (serum cortisol) measurements were performed. American Society of Anesthesiologists (ASA) grades 1 and 2, and patients aged 18 to 65 years were included. Pain perception was assessed using the Visual Analog Scale (VAS). Results The demographic data, including mean age, BMI, ASA status, average duration of anesthesia, and average duration of surgery, were comparable between the two groups. Group M showed improved control of systolic blood pressure (SBP) at 10- and 30-minutepost-induction of general anesthesia and had a significantly lower VAS score (p < 0.05). Additionally, patient satisfaction was higher in Group M (81.4%) compared to Group C (51.4%) with a p-value of < 0.05. Intraoperative awareness was non-significant between the groups. Conclusion Music therapy is a safe, cost-effective, and efficacious method for reducing pain perception and can be used in conjunction with other treatments for postoperative pain management.

Study protocol of the FRENCH24-ANIS study: postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stents—an intergroup FRENCH-ACHBT-SFAR prospective randomized controlled trial

BackgroundDespite advances in surgical techniques and care, pancreatoduodenectomy (PD) continues to have high morbidity and mortality rates. Complications such as sepsis, hemorrhage, pulmonary issues, shock, and pancreatic fistula are common postoperative challenges. A key concern in PD outcomes is the high incidence of infectious complications, especially surgical site infections (SSI) and postoperative pancreatic fistula (POPF). Bacteriobilia, or bile contamination with microorganisms, significantly contributes to these infections, increasing the risk of early postoperative complications. The occurrence of SSI in patients who undergo hepatobiliary and pancreatic (HPB) surgeries such as PD is notably higher than that in patients who undergo other surgeries, with rates ranging from 20 to 55%. Recent research by D'Angelica et al. revealed that, compared to cefoxitin, piperacillin/tazobactam considerably lowers the rate of postoperative SSI. However, these findings do not indicate whether extending the duration of antibiotic treatment is beneficial for patients at high risk of bacterial biliary contamination. In scenarios with a high risk of SSI, the specific agents, doses and length of antibiotic therapy remain unexplored. The advantage of prolonged antibiotic prophylaxis following PD has not been established through prospective studies in PD patients following biliary drainage.MethodsThis is an intergroup FRENCH-ACHBT-SFAR multicenter, open-labelled randomized, controlled, superiority trial comparing 2 broad-spectrum antibiotic (piperacillin/tazobactam) treatment modalities to demonstrate the superiority of 5-day postoperative antibiotic therapy to antibiotic prophylaxis against the occurrence of surgical site infections (SSI) following pancreaticoduodenectomy in patients with preoperative biliary stents. The primary endpoint of this study is the overall SSI rate, defined according to the ACS NSQIP, as a composite of superficial SSI, deep incisional SSI, and organ/space SSI.In addition, we will analyze overall morbidity, antibiotic resistance profiles, the pathogenicity of bacteriological and fungal cocontamination, the impact of complications after bile drainage and neoadjuvant treatment on the bacteriological and fungal profile of biliculture and cost-effectiveness.ConclusionThis FRENCH24-ANIS study aims to evaluate 5-day post-operative antibiotic therapy combined with antibiotic prophylaxis on the occurrence of surgical site infections (SSI) following pancreaticoduodenectomy in patients with preoperative biliary stents.Trial registrationClinicaTrials.gov number, NCT06123169 (Registration Date 08–11–2023); EudraCT number 2021–006991-18; EUCT Number: 2024–515181-14–00.

The effect of prophylactic tranexamic acid on the incidence of postoperative hemorrhage in greyhounds

To investigate whether the incidence of postoperative hemorrhage in greyhounds was reduced when a standardized protocol for prophylactic tranexamic acid (TXA) administration to greyhounds undergoing surgery was followed, a retrospective clinical study at a private referral and first opinion hospital group was performed. Patient records of client-owned greyhounds undergoing elective surgery or dental procedures involving extractions were examined retrospectively, and 58 incidents of surgery considered eligible were documented, along with any subsequent reports of hemorrhage and whether the TXA protocol was followed.The use of TXA was not associated with a reduction in the incidence of postoperative hemorrhage in this population of greyhounds. In the group that did not receive TXA, post-operative hemorrhage was reported in 7/37 (18.9 %) cases and in the prophylactic TXA group, post-operative hemorrhage was reported in 11/21 (52.4 %) cases, a significantly higher number than in the group that did not receive TXA. Interestingly, in our population, prophylactic administration of TXA was not associated with a reduction in post-operative hemorrhage, but with a higher incidence of hemorrhage. We belief that descrepencies in our dataset may explain these findings, and a prospective randomized-controlled trial should be performed to further investigate the efficacy of TXA as an antifibrinolytic agent in greyhounds.

Effect of intra-operative Magnesium sulphate on the occurrence of post-operative delirium and insomnia in patients undergoing lumbar fixation: a randomized controlled trial

BackgroundOver the last two decades, a large body of literature has focused on studying the prevalence and outcome of the postoperative delirium and sleep disturbance. The aim of this work was to evaluate the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in patients undergoing lumbar fixation.MethodsThis prospective randomized controlled trial was carried out on 80 patients indicated for lumbar fixation; 40 of them received conventional general anesthesia with extra administration of intraoperative magnesium sulphate (Mg sulphate group), and the other 40 received conventional general anesthesia only (control group). Both groups were submitted to pre-operative assessment of depression using Beck Depression inventory (BDI) scale, pre-operative assessment of fatigue using a fatigue questionnaire, pre- and post-operative assessment of insomnia using Insomnia severity index (ISI), post-operative assessment of delirium using Memorial delirium assessment scale (MDAS), post-operative assessment of pain using Visual Analogue Scale (VAS), and pre- and post-operative Quantitative electroencephalography (QEEG).ResultsMg sulphate administration, age, pre-operative BDI, pre-operative ISI, and post-operative VAS were independent predictors of post-operative ISI (P-value < 0.001, 0.047, 0.021, < 0.001, and < 0.001 respectively). Age and post-operative VAS were independent predictors of post-operative MDAS (P-value = 0.008, 0.013 respectively). Mg sulphate administration and pre-operative ISI were independent predictors of post-operative VAS (P-value = 0.010, 0.006 respectively).ConclusionThere was a significant relationship between intraoperative Mg sulphate administration and both post-operative insomnia and pain in unadjusted and adjusted analysis.

Perioperative bleeding control in total hip arthroplasty: hemostatic powder vs. tranexamic acid-a prospective randomized controlled trial.

Perioperative bleeding in total hip arthroplasty (THA) can lead to various problems, so effective management of blood loss is needed. This prospective, single-blind, randomized controlled trial aimed to compare the efficacy of topical administration of SURGICEL® (a hemostatic agent of oxidized regenerated cellulose) powder (SP) and tranexamic acid (TXA) in controlling perioperative bleeding during THA. In total, 114 patients undergoing THA for osteoarthritis were randomized to either group S (THA with SP) or group T (THA with TXA). Data including patient demographics, laboratory data (C-reactive protein [CRP], hemoglobin, and hematocrit), operative time, and intraoperative blood loss were analyzed. Clinical outcomes were assessed using WOMAC, JOA, FJS scores, and visual analog scale (VAS) scores. Primary outcomes were estimated total and postoperative blood loss, while secondary outcomes included hematological test results and various clinical scores. 57 patients were allocated to each group, with 55 in group S and 56 in group T were finally included in the analysis. There was no significant difference (p = 0.141) in estimated total blood loss between group S (788.2 ± 350.1ml) and group T (714.1 ± 318.4ml). Hemoglobin and hematocrit levels and WOMAC, and FJS scores were not significantly different between the two groups at any time point. CRP levels were significantly different on postoperative days 4 and 7, and JOA score was significantly different on preoperative and postoperative period. However, the differences in CRP and JOA score values themselves were relatively small and not clinically different. Topical administration of SP is as effective as TXA in reducing perioperative bleeding in patients undergoing THA. Additionally, no significant difference was observed in early postoperative clinical outcomes between SP and TXA. Therapeutic Level I. The University Hospital Medical Information Network (UMIN) registration number UMIN000047607.

MS treatment de-escalation: review and commentary.

Almost all currently licensed disease-modifying therapies (DMTs) for MS treatment require prolonged if not lifelong administration. Yet, as people age, the immune system has increasingly reduced responsiveness, known as immunosenescence. Many MS DMTs reduce the responsiveness of the immune system, increasing the risks for infections and possibly cancers. As people with MS (pwMS) age, it is recognized that inflammatory MS activity declines. Several studies have addressed de-escalation of DMTs for relapsing MS under special circumstances. Here, we review evidence for de-escalating DMTs as a strategy that is particularly relevant to pwMS of older age. Treatment de-escalation can involve various strategies, such as extended or reduced dosing, switching from high-efficacy DMTs having higher risks to moderately effective DMTs with lesser risks, or treatment discontinuation. Studies have suggested that for natalizumab extended dosing maintained clinical efficacy while reducing the risk of PML. Extended interval dosing of ocrelizumab mitigated the decline of Ig levels. Retrospective and observational discontinuation studies demonstrate that age is an essential modifier of drug efficacy. Discontinuation of MS treatment in older patients has been associated with a stable disease course, while younger patients who discontinued treatment were more likely to experience new clinical activity. A recently completed 2-year randomized-controlled discontinuation study in 260 stable pwMS > 55years found stable clinical multiple sclerosis with only a small increased risk of new MRI activity upon discontinuation. DMT de-escalation or discontinuation in MS patients older than 55years may be non-inferior to continued treatment with immunosuppressive agents having higher health risks. However, despite several small studies, a definite conclusion about treatment de-escalation in older pwMS will require larger and longer studies. Ideally, comparison of de-escalation versus continuation versus discontinuation of DMTs should be done by prospective randomized-controlled trials enrolling sufficient numbers of subjects to allow comparisons for MS patients of both sexes within age groups, such as 55-59, 60-65, 66-69, etc. Optimally, such studies should be 3years or longer and should incorporate testing for specific markers of immunosenescence (such as T-cell receptor excision circles) to account for differential aging of individuals.

Ultrasonography-guided corticosteroid injection in the coracohumeral ligament in patients with adhesive capsulitis of the shoulder: a double-blinded, sham-controlled randomized study

BackgroundContracture and thickening of the coracohumeral ligament (CHL) occur in patients with adhesive capsulitis. This adversely affects the movement and function of the shoulder joint. There is limited evidence that explores the effectiveness of an isolated steroid injection into CHL in combination with physical therapy. This prospective randomized control trial aimed to evaluate the clinical effects of ultrasound-guided corticosteroid injection compared to a sham injection into the CHL in subjects with adhesive capsulitis. MethodsForty patients (23 males, 52.2 ± 8 years of age) with unilateral adhesive capsulitis (with 5.4 ± 2 months mean duration of symptoms) were randomly assigned to either the experimental or control group. Both groups received ultrasound-guided injections into the CHL. The experimental group (n=20) received corticosteroids and the control group (n=20) received a sham lidocaine injection. All subjects underwent supervised conventional physical therapy three times a week for 3 months. Subjects were evaluated for improvements in pain, range of motion, and disability at 6 and 12 weeks as compared to pre-injection baseline measurements. Data were compared statistically across groups and times at p<0.05. The CHL thickness was compared at baseline across sides using paired t-tests. ResultsThe experimental group showed statistically greater improvements in pain, functional scores, flexion, abduction, internal and external rotation range of motion at 12 weeks compared to the control group. Pain reduction was observed in both groups at 6 and 12 weeks, but the experimental group exhibited significantly greater reductions. The CHL was significantly thicker on the affected side as compared to the unaffected side (p<0.001). Discussion and ConclusionThis study partially supported the hypothesis. Notably, significant improvements in pain, range of motion, and functional scores were observed at 12 weeks in the experimental group. The greater improvements in pain and external rotation may have resulted in lower disability scores in the experimental group. The results emphasize the importance of targeted intervention into the CHL.

Efficacy of Dexamethasone in Reducing Pain and Inflammation and Accelerating Total Hip Arthroplasty Postoperative Recovery: A Randomized Controlled Trial

PurposeTo evaluate the efficacy of dexamethasone in reducing pain and accelerating recovery after total hip arthroplasty (THA). DesignA prospective randomized controlled trial. MethodsA total of 98 patients who underwent THA received either low-dose (10 mg) dexamethasone (dexa group) or isotonic saline (placebo group). C-reactive protein and interleukin-6 levels were recorded at 24, 48, and 72 hours after surgery. Pain visual analog scale (VAS) score at rest and walking, the incidence of postoperative nausea and vomiting (PONV), nausea VAS score, postoperative identity-consequence fatigue scale rating, antiemetic use, postoperative length of stay (PLOS), and complications were also recorded and compared. FindingsInflammatory marker (C-reactive protein and interleukin-6) levels at 24, 48, and 72 hours postoperatively in the dexa group were lower than that in the placebo group (P < .05). After 24 hours of rest, the dynamic pain VAS scores in the dexa group were lower than those in the placebo group (P < .05). The incidence of PONV, nausea VAS score, and identity-consequence fatigue scale score in the dexa group were lower than those in the placebo group (P < .05), and the dosages of analgesics and antiemetics were also lower (P < .05). In addition, PLOS in the dexa group was shorter than that in the placebo group (P < .05). No significant difference in perioperative complications between the two groups was observed (P > .05). ConclusionsLow-dose dexamethasone in the THA perioperative period can effectively reduce inflammatory marker levels, pain, nausea, postoperative fatigue, opioid analgesic use, and shorten PLOS without increasing complications.