Prospective Randomized Control Trial Research Articles

Closed trans-intersphincteric fistulotomy: a new modified sphincter-sparing technique for high transsphincteric anal fistula

BackgroundThe main goals of surgery for fistula-in-ano are to completely resolve the condition and maintain optimal anal function. Effective management of the internal opening during and proper postoperative drainage of the intersphincter plane are crucial for achieving successful outcomes. This study evaluated the clinical efficacy of a novel sphincter-sparing technique for treating high transsphincteric anal fistula (HTAF).MethodsThis prospective study included 55 patients with HTAF who underwent closed trans-intersphincteric fistulotomy (CTiF) between July 2021 and April 2022 at our institution. Preoperative anorectal magnetic resonance imaging was performed for all patients. The primary outcome measures assessed the rate of fistula healing while the secondary outcome measures evaluated healing time, Cleveland Clinic Florida fecal incontinence score (CCF-FIS), 11-point visual analog scale (VAS) pain score and postoperative complications.ResultsWe included 55 patients with HTAF in this study. During a mean follow-up period of 9.3 months, CTiF achieved a healing rate of 90.91% (50/55). The mean time to recovery was 7.09 ± 1.94 weeks. Four (7.27%) patients developed postoperative urinary retention. At the 6-month follow-up, the CCF-FIS and VAS score were 0 [(0,0) range, 0–3] and 0 [(0,1); range, 0–4], respectively. Two patients with recurrent HTAF recovered after treatment with a transanal opening of intersphincteric space procedure, and three recovered after seton placement.ConclusionsCTiF is a promising and effective sphincter-sparing technique for treating HTAF. To confirm long-term outcomes, larger sample size prospective randomized controlled trials are required.

Efficacy of preoperative prophylactic application of betamethasone on postoperative nausea and vomiting in patients undergoing total knee arthroplasty: a prospective randomized controlled trial

BackgroundThe demand for total knee arthroplasty (TKA) is increasing, yet postoperative nausea and vomiting (PONV) significantly hinder patient recovery. Preoperative prophylactic administration of glucocorticoids can alleviate PONV, with betamethasone showing promising results in breast and cardiac surgeries. However, its efficacy in TKA patients remains unclear. This study evaluates the efficacy and safety of preoperative betamethasone for PONV in TKA patients through a prospective randomized controlled trial (RCT).Materials and methodsIn this trial, 124 patients were randomly assigned to receive either 2 mL of normal saline (control group) or 2 mL of betamethasone sodium phosphate (10.52 mg total dose; experimental group) 10 min before anesthesia induction. Primary outcomes included nausea severity, vomiting frequency, and antiemetic use, while secondary outcomes were pain scores, knee range of motion, blood glucose, IL-6, CRP, ESR, and adverse reactions.ResultsResults showed the experimental group had significantly lower nausea severity at 2, 4, 6, 12, and 24 h post-surgery compared to controls. The average frequency of vomiting in the experimental group (0.060 ± 0.307) was lower than that in the control group (0.390 ± 0.662), with a statistical difference (P < 0.001). The postoperative use of metoclopramide in the experimental group (0.480 ± 2.163) was lower than that in the control group (4.520 ± 6.447), and there was a statistical difference between the two groups (P < 0.001). CRP in the experimental group on the second day after surgery (45.741 ± 47.044) was lower than that in the control group (65.235 ± 50.970), with a statistical difference (P = 0.014). IL-6 in the experimental group was lower on the first (51.853 ± 67.202) and second postoperative days (25.143 ± 31.912) than that in the control group on the first (79.477 ± 97.441) and second postoperative days (38.618 ± 36.282), with statistical differences (P = 0.039, P = 0.006). There was no significant difference in postoperative knee pain, knee range of motion, blood glucose, ESR, and adverse reactions between the two groups.ConclusionOur prospective RCT demonstrates that preoperative betamethasone is effective and safe for reducing PONV in TKA patients, suggesting a new clinical approach for prophylactic treatment of PONV post-TKA.

Efficacy and safety of sacubitril/valsartan on postoperative atrial fibrillation in adult patients undergoing cardiac surgery: a real-world observational study.

The mechanism underlying new-onset postoperative atrial fibrillation (POAF) in adult cardiac surgery is not well understood. However, efficient pharmacological methods to prevent and treat arrhythmic complications are still lacking. In the present study, we explored the efficacy and safety of sacubitril/valsartan (sac/val) in the control of POAF in adult cardiac surgery patients. Between January 2021 and December 2021, 667 eligible adult patients who underwent cardiac surgery at the Affiliated Hospital of Qingdao University were enrolled. The participants were divided into two groups according to whether sac/val was used: the sac/val group (N = 101) and the control group (N = 566). The main observational endpoints were the incidence of POAF, left ventricular ejection fraction (LVEF) recovery, in-hospital mortality, and short-term mortality. Patients in the sac/val group had a lower incidence of POAF than those in the control group (26/101 vs. 204/566, P = 0.045). Patients in the sac/val group also showed a higher communicative risk for POAF incidence using the Kaplan-Meier survival analysis. In addition, patients in the sac/val group showed better LVEF recovery, with dynamic changes in LVEF superior to that of the control group. The change in LVEF in the sac/val group was 1.78 ± 5.41, compared with -1.19 ± 10.92 in the control group (P = 0.008). This is the first observational study to evaluate the efficacy and safety of sac/val in the prevention and treatment of POAF after cardiac surgery. The results demonstrated that compared with patients who did not receive sac/val treatment, those who received Sac/val treatment showed better POAF control and LVEF recovery. These results should be cautiously interpreted and further confirmed using larger sample sizes and prospective randomized controlled trials.

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.

Comparative Systematic Review and Meta-Analysis Between Robotic and Laparoscopic Abdominoperineal Resection for Rectal Cancer: Oncological and Short-Term Outcomes.

Minimally invasive surgery, especially robotic surgery, has become increasingly popular in colorectal surgery over the last decade. Robotic-assisted surgery has shown better outcomes than conventional laparoscopic surgery because of superior ergonomics, high-resolution three-dimensional cameras, and articulating instruments; however, issues like the long operative time and cost-effectiveness remain unresolved. This study compares the robotic and laparoscopic approach of abdominoperineal resection (APR) for low rectal cancer to evaluate the superiority of robotic surgery in short-term and oncological outcomes. This meta-analysis used Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and principles. We conducted a systematic search in the PubMed, Cochrane, Google Scholar, and ResearchGate databases, and seven studies were included after the standardized quality check. Inclusion criteria involved any patient at the age of 18 or above with low rectal cancer who underwent APR with the exclusion of studies that are not in English, patients who underwent open surgery, and patients with recurrent cancer. A total number of 10,331 participants from seven eligible studies were involved in this review and meta-analysis with 1499 in the robotic group and 8,895 in the laparoscopic group. The oncological outcome showed that the positive resection margin is significantly higher in the laparoscopic group with a mean difference (MD) of 0.35, 95% CI (0.14, 0.89), and P = 0.03. The difference in the number of harvested lymph nodes between the robotic and laparoscopic APR is not statistically significant with an OR of 0, 95% CI (-0.19, 0.19), and P = 0.98. The operative time was found to be higher in the robotic group with an MD of 11.25, 95% CI (9.25, 13.04), and P = 0.0001. A higher conversion rate was reported in the laparoscopic group with OR 0.38, 95% CI (0.28, 0.51), and P = 0.00001. The length of the hospital stay was less in the robotic group with an MD of 2, 95% CI (-2.08, -1.92), and P = 0.00001. A lower rate of postoperative ileus was found in the robotic group with an odd ratio of 0.74, 95% CI (0.61,0.89), and P = 0.001, which is statistically significant. The mortality rate and thromboembolic complication also showed a significantly higher rate in the laparoscopic group with an OR of 0.15, 95% CI (0.03, 0.84), and P = 0.03 and an OR of 0.14, 95% CI (0.03, 0.69), and P = 0.02, respectively. There is no statistically significant difference between the robotic and laparoscopic groups in the surgical site infection, urinary dysfunction, cardiac, and pulmonary complications. In conclusion, our study findings indicated that robotic APR has a better short-term outcome and negative circumferential resection margins compared to laparoscopic APR. However, more research and prospective randomized controlled trials are needed to determine the efficiency, cost effectiveness, recurrence, and survival rate in robotic APR.

Dye-based chromoendoscopy versus i-scan virtual chromoendoscopy in long-standing ulcerative colitis: Multicenter prospective RCT.

Background and study aims Long-standing ulcerative colitis (UC) is associated with an increased risk of developing colorectal neoplasia. Both dye-based chromoendoscopy (DCE) and virtual chromoendoscopy (VCE) increase detection of neoplastic lesions. In this prospective randomized controlled trial (RCT), we compared the neoplasia detection rate between DCE and i-scan VCE in patients with long-standing UC. Patient and methods In four European hospitals, 131 patients with long-standing UC (disease duration > 8 years) were randomized to either DCE with methylene blue 0.1% (n = 66) or i-scan VCE (n = 65). All procedures were performed by trained endoscopists. Biopsies were taken from all visible lesions and the surrounding mucosa. Results The mean number of neoplastic lesions detected per colonoscopy was not significantly different between DCE (0.27) and i-scan VCE (0.37) ( P = 0.41). Similarly, there was no significant difference in neoplasia detection rate between DCE (19.7%) and VCE (27.7%) (odds ratio0.64, 95% confidence interval 0.28-1.50, P = 0.31). However, the per lesion neoplasia detection rate was significantly higher with i-scan VCE compared to DCE (27.6% vs 15.3%, P = 0.036). Both withdrawal and total procedure time were on average 10.0 and 9.9 minutes shorter using i-scan VCE (both P < 0.001). Conclusions This multicenter, prospective RCT showed no significant difference in neoplasia detection between DCE and i-scan VCE in long-standing UC. However, use of i-scan VCE was associated with a lower false-positive rate and a significantly shorter procedure time compared with DCE. I-scan VCE, therefore, could be a valid replacement for DCE in UC surveillance colonoscopies.

Lidocaine patches after cesarean sections: a randomized control trial

ObjectivesLidocaine patches are a common topical analgesic therapy but have not been thoroughly investigated in the surgical or obstetric literature. We sought to investigate the impact of adding topical lidocaine patches to routine postcesarean pain management on patients’ postcesarean pain scores and opioid use. Study DesignThis is a prospective randomized subject-blinded controlled trial of patients undergoing cesarean delivery at a single institution. Individuals were excluded if they had three or more cesarean sections (CS), abdominoplasty, history of abdominal hernia repair with mesh, active polysubstance use, or history of opiate use disorder with current medication-assisted treatment. Patients were randomized via a 1:1 randomization scheme to a placebo patch or lidocaine patch. Baseline maternal characteristics were collected. The primary outcome was mean visual analog pain scores (0–10). Our secondary outcome was total morphine equivalents used over the postoperative hospital stay. Pre- and poststudy surveys were performed to evaluate subject's prior analgesia use (including opioids) and patient experience in the study. ResultsA total of 100 patients were randomized and 93 had complete data for analysis (46 placebo group, 47 treatment group). Groups had similar baseline characteristics (age, BMI, ethnicity, surgical time, and estimated blood loss). Mean maximum postoperative pain score by visual analog scale did not differ between placebo or lidocaine patch groups on postoperative day (POD) 1 (P=.3), day 2 (P=.9), day 3 (P=.07), or day 4 (P=.09). Mean postoperative pain score by visual analog scale did not differ between placebo or lidocaine patch groups on POD 1 (P=.7), day 2 (P=.6), day 3 (P=.2), or day 4 (P=.5). In the poststudy survey, 0% of the respondents in the lidocaine patch group reported disruption of their care and 63% reported desired use of lidocaine patch in the future. ConclusionThe addition of lidocaine patches did not significantly decrease the maximum or average postoperative pain scores via visual analog scale after CS. More research is needed into nonopioid pain management strategies in the postoperative period in obstetric care.

Fusion Free Median Corpectomy - Long-Term Consequence of Foregoing Fusion and Fixation: A Serendipitous Observation.

Anterior cervical corpectomy and fusion (ACCF) involves placement of a graft/implant to ensure fusion and stabilization along with neural decompression. We share our experience with a subset of ACCF patients in whom graft/implant could not be placed post decompression for varying reasons but had a favorable long-term outcome. The necessity for routine fusion after corpectomy is critically analyzed, and the feasibility of an alternative surgical option without graft/implant is discussed. A retrospective observational study of long-term outcomes of five patients with cervical compressive myelopathy who underwent neural decompression alone without an in situ graft/implant was done. All the patients underwent the modified cervical corpectomy technique, involving a smaller wedge size (12 × 15 mm) corpectomy. Pre- and postoperative clinical, radiological, electrophysiological, and operative findings were meticulously evaluated and analyzed. This retrospective observational study reviewed records of 124 patients who underwent ACCF between 1998 and 2012. The surgical procedure involved a wedge median cervical corpectomy. In seven patients, graft/implant could not be placed or had to be removed for various reasons. Long-term follow-up was available for five of these patients who were included in the study. In two patients, the graft could not be placed intraoperatively due to hemodynamic complications. In one patient, the graft had to be removed due to postoperative infection, and in two patients, the graft had to be removed due to graft extrusion. Four patients showed marked improvement, and one patient showed minimal improvement on long-term follow-up in clinical, radiological, and electrophysiological parameters. This small case series suggests that a modified cervical corpectomy technique, involving a smaller wedge size (12 × 15 mm), may be considered in selected cases without radicular symptoms. This approach helps to provide neural decompression without compromising stability and avoids graft-related complications. While promising, further research, including prospective randomized-controlled trials, is essential to validate the biomechanical properties and clinical outcomes of this modified technique compared to traditional ACCF.

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.

The Effect of Quadratus Lumborum Block vs Erector Spinae Block in Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Abstract Background However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage. Aim of the Work to compare analgesic efficacy of Quadratus lumborum block versus erector spinae block in postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Study Design prospective randomized controlled clinical trial Methods This prospective randomized controlled clinical trial was conducted at operative theatres, Anesthesiology, Intensive Care and Pain Management Department, Faculty of Medicine, Ain Shams University Hospitals from March until August 2023. During this study, 80 patients electively scheduled for laparoscopic cholecystectomy were enrolled and divided into two equal groups; group A subjected to quadratus lumborum block and group B subjected to erector spinae block. Intraoperative, Post Anaesthesia Care Unit and postoperative haemodynamic, postoperative VAS score, first time of postoperative analgesic request, total amount of postoperative analgesia, time needed for postoperative mobilization and side effects of study procedures were evaluated. Results In this study there was no significant difference between the two groups as regards VAS score. In this study there was no significant difference between the two groups according to total amount of analgesia needed post operatively. In this study there was no significant difference between the two groups according to total amount of analgesia needed post operatively. In this study time needed for mobilization was insignificant different between two groups. In this study, no statistically significant disparity was observed between the two groups in terms of side effects. In this study, no significant difference was found between the two groups according to the first time postoperative analgesia. Conclusion This study showed comparable effect of both QLB and ESPB in patients undergoing laparoscopic cholecystectomy.

Evaluation of the Outcomes of Primary Closure after Open Common Bile Duct Exploration for Common Bile Duct Stones

Abstract Background The incidence of CBD stone develops in about 10–15% of patients with gall bladder stones and encountered in approximately 7–15% of patients undergoing cholecystectomy. It is common to be treated by endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST), however in cases who has large or multiple CBD stone or difficult to be cleared by ERCP. Aim of the Work To evaluate of the outcomes of primary closure after open common bile duct exploration for removal of common bile duct stones. Methods This descriptive prospective randomized clinical controlled trial was conducted on 30 patients at Hepatobiliary Pancreatic Department (HBP) - Faculty of Medicine – Ain Shams University from January 2022 until March 2023. Primary closure was performed after removal of CBD stones with follow up for 6 months. Results Operative time ranged from 1.3 to 3 hours with mean 2.03 and ± SD 0.48 hours. Biliary leakage was estimated 13.3% of the candidates (4 cases). One of the 30 patients developed CBD stricture. Total and direct bilirubin levels were statistically significant decrease in T and direct bilirubin in follow up “1st 5 days and post-operative 10th day”. Conclusion The primary closure after open common bile duct exploration for removal of common bile duct stones is a safe, effective and time saving procedure.

Assessment of Topical PUVA in Acral Vitiligo

Abstract Acral vitiligo is a resistant subtype of vitiligo that does not respond easily to any treatment modalities. Topical psoralen plus ultraviolet A (topical PUVA) therapy is an option in case of localized dermatosis such as acral vitiligo. Ultraviolet A therapy can penetrate the dermis of the skin. This study objective was to evaluate the effect of topical PUVA in acral vitiligo. Methods Patients in this prospective randomized-controlled comparative clinical trial were divided in to two groups, first group received narrow band ultraviolet B (NB-UVB) and topical PUVA at the same time, second group were already on NB-UVB and topical PUVA were added. Patients received 36 sessions of phototherapy over a period of 16 weeks. Every patient was evaluated monthly using point counting. Results No statistically significant difference was found between both groups regarding response. Conclusion Topical PUVA is of limited use in acral vitiligo.

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.