Prospective Randomized Study Research Articles

A comparative study to evaluate the efficacy of cisatracurium and rocuronium for endotracheal intubation in pediatric patients: A prospective randomized study

Background: Cisatracurium and rocuronium are non-depolarizing neuromuscular blockers with an intermediate duration of action and are used safely in short and intermediate-duration surgical procedures in the pediatric population. Aims and Objectives: A prospective randomized study is to assess the efficacy of cisatracurium compared to rocuronium in terms of intubating conditions, clinical duration of action, hemodynamic parameters, and side effects in pediatric patients undergoing surgeries under general anesthesia. Materials and Methods: In this study, 50 patients aged 2–12 years with the American Society of Anesthesiologists grades I and II were randomly allocated into two groups: Group I received injection cisatracurium 0.15 mg/kg IV and Group II received injection rocuronium 0.6 mg/kg IV for intubation. Intubating conditions by Cooper et al., score, TOF count, hemodynamic parameters, signs of histamine release, and complications if any were noted. Results: According to the Cooper et al., score, intubating conditions were excellent in 100% of patients in Group II and 84% of patients in Group I, which was statistically significant. The time required for the first maintenance dose was shorter in Group II (14.04±2.95 min) compared to Group I (20.08±3.68 min). Hemodynamic parameters and demographic profiles were comparable between the two groups. No associated signs of histamine release or any other complications were noted in either group. Conclusion: We concluded that rocuronium 0.6 mg/kg provides better intubating conditions and a shorter duration of action compared to cisatracurium 0.15 mg/kg without any signs of histamine release in pediatric patients.

A comparative study of low-dose intrathecal bupivacaine 0.5% (heavy), levobupivacaine 0.5% (plain), and levobupivacaine 0.5% (heavy) with fentanyl as an adjuvant in transurethral resection of prostate surgery: A prospective randomized study

Background: Spinal anesthesia is the technique of choice for transurethral resection of the prostate (TURP) surgeries. Levobupivacaine, an S-enantiomer of bupivacaine, is less cardiotoxic than bupivacaine; therefore, a low dose of local anesthetic with fentanyl as an adjuvant has been used to decrease toxicity and increase efficacy. Aims and Objectives: The aim of this study was to compare and evaluate the efficacy of hyperbaric bupivacaine 0.5%, isobaric levobupivacaine 0.5%, and hyperbaric levobupivacaine 0.5% with fentanyl as an adjuvant. Materials and Methods: One hundred and five patients scheduled for elective TURP surgeries were randomly divided into three groups. Group BH (n=35) received 1.5 mL of 0.5% hyperbaric bupivacaine with 25 μg of fentanyl, Group LH (n=35) received 1.5 mL of 0.5% hyperbaric levobupivacaine with 25 μg of fentanyl, and Group LP (n=35) received 1.5 mL of 0.5% isobaric levobupivacaine with 25 μg of fentanyl intrathecally. Results: The onset of sensory and motor block was earlier and the duration of analgesia and motor block were longer in the BH group (P<0.001) as compared to LH and LP groups. The demographic data, duration of surgery, heart rate, SpO2, pruritus, and shivering were comparable between the groups (P>0.05). The visual analog scale score was higher in the LP group. Hypotension, nausea, and vomiting were seen in the BH group. Conclusion: Hyperbaric is better than isobaric group due to quicker onset and longer duration. Levobupivacaine is better than bupivacaine in terms of the early mobilization and a lesser incidence of side effects, making hyperbaric levobupivacaine a better alternative to isobaric levobupivacaine and hyperbaric bupivacaine.

Comparison of the effect of intrathecal fentanyl citrate and magnesium sulfate as adjuvants to hyperbaric levobupivacaine 0.5% for spinal anesthesia in patients undergoing lower limb orthopedic surgeries

Background: Subarachnoid blockade is a safe, reliable, and inexpensive technique that provides surgical anesthesia along with prolonged post-operative analgesia. The quality of subarachnoid block is enhanced by the addition of intrathecal adjuvants, such as fentanyl citrate and magnesium sulfate to hyperbaric levobupivacaine. Aims and Objectives: The aim of this study was to compare the effects of fentanyl and magnesium sulfate as adjuvants to 0.5% hyperbaric levobupivacaine in orthopedic surgeries under subarachnoid block. Materials and Methods: This prospective randomized study included 90 American Society of Anesthesiologists Grade I and II patients aged 18–60 years undergoing orthopedic surgeries. Group LS received 3 mL 0.5% levobupivacaine heavy+0.5 mL normal saline. Group LF received 3 mL 0.5% levobupivacaine heavy+fentanyl 25 μg, and Group LM, 3 mL 0.5% levobupivacaine heavy+magnesium sulphate 50 mg+0.4 mL normal saline. The onset and duration of sensory and motor block and intraoperative hemodynamics were recorded. In the post-operative period, duration of analgesia, Visual Analog Scales scores, and side effects were observed. Results: The onset of sensory block was 4.04±0.74 min in Group LM (P<0.001) as compared to Groups LF (2.01±0.23 min) and LS (2±0.24 min). The onset of motor blockade took 5±1.14 min in the control group, 7.01±0.94 in group LF, and 8.11±1.33 min in group LM (P<0.001). The duration of analgesia in group LS was 183.73±12.08 min, 317±18.6 min in group LF, and 219.43±20.89 in group LM (P<0.001). Conclusion: The addition of fentanyl and magnesium as adjuvants enhanced the quality of subarachnoid block when added to hyperbaric levobupivacaine. The duration of analgesia was longest in fentanyl, followed by magnesium and then control. The incidence of side effects was greatest in fentanyl, followed by control and nil in magnesium.

Comparison of endoscopic tympanoplasty, cartilage vs. temporalis fascia in chronic suppurative otitis media with inactive mucosal disease: A prospective randomised study.

The introduction of endoscopy into middle ear has open up new opportunities for minimal invasive temporal bone surgery. The present study was planned to compare anatomical and functional outcome in patients who underwent endoscope assisted tympanoplasty using cartilage and temporalis fascia graft. The present prospective observational randomized study was carried out in the Department of Otorhinolaryngology of a tertiary care teaching hospital of Rajasthan, India from September 2020 to July 2021. Fifty patients of age group 18-60 years, with diagnosis of chronic otitis media having inactive mucosal disease were enrolled in the study and divided into two groups viz. cartilage (group I) and temporalis fascia group (group II). Each patient postoperatively underwent otoscopic examination of ear and pure tone audiometery at 8 weeks and 3rd month. Local wound condition, graft uptake and healing and hearing were assessed and compared. Graft uptake was 92% in cartilage group and 84% in temporalis fascia group. Air conduction and air-bone gap of patients in both the groups showed significant improvement after 3 months of surgery. (p˂0.05) Regarding bone conduction, both groups had shown non-significant changes. (p > 0.05) Hearing gain was comparable on both groups which was 6.71dB in cartilage group vs. 5.9 dB in other group. The present study showed that graft placement time for temporalis fascia graft was less than cartilage graft, but the difference was insignificant. Hearing improvement, graft uptake and clinical improvement were found to be statistically insignificant between both groups.

A comparative study to assess the effects of intrathecal fentanyl and intrathecal tramadol combined with 0.5% bupivacaine heavy in patients undergoing elective urological surgeries: A prospective randomized study

Background: Urological operations frequently involve the use of spinal anesthesia. In the present scenario, adding different adjuvants to local anesthetic improve its quality and duration has become common. Aims and Objectives: In patients undergoing elective urological procedures, the purpose of this study was to assess the effects of intrathecal fentanyl or tramadol with 0.5% bupivacaine heavy. Materials and Methods: Patients were divided into two groups of 30 patients each, a total of 60 patients aged 20–60 years undergoing elective urological surgeries participated in this prospective, randomized study in which 25 μg fentanyl and 2.5 mL of 0.5% bupivacaine heavy were given to Group F, while 25 mg tramadol and 2.5 mL of 0.5% bupivacaine heavy were given to Group M. The onset and duration of sensory and motor blockage, the duration of analgesia, post-operative Visual Analog Scale score, hemodynamic changes, and adverse effects were evaluated. Results: Fentanyl had a lower mean time of onset for sensory (2:33±0:22 min vs. 4:50±0:33 min) and motor block (3:36±0:28 min vs. 5:52±0:38 min) (P<0.001), the duration of sensory (185.67±3.155 min vs. 152.60±4.264), motor block (172.00±4.177 min vs. 136.40±5.575 min), and post-operative analgesia was longer in the fentanyl group (P<0.001), whereas the incidence of adverse effects such as pruritus, shivering, and nausea was lower in the tramadol group. Conclusion: The quality and duration of spinal anesthesia were found to be significantly increased by the use of fentanyl as an adjuvant in our study. However, tramadol also produced stable hemodynamics and exhibited fewer adverse effects than fentanyl.

Safety and Efficacy of Tubeless Percutaneous Nephrolithotomy: A Prospective Randomized Study

Background: Urinary lithiasis, or kidney stone disease, is a common and longstanding health issue characterized by significant morbidity and recurrence. Despite advancements in treatment modalities, managing large or complex renal stones continues to pose challenges. The evolution of surgical techniques, such as percutaneous nephrolithotomy (PCNL), has significantly impacted the management of kidney stones. This study aims to evaluate the safety and efficacy of tubeless PCNL compared to conventional PCNL in patients with renal and upper ureteric stones. Methods: A prospective randomized study was conducted at the Urology and Nephrology University Hospital, Assiut University, Egypt, from September 2016 to September 2019. The study included 60 patients who met the inclusion criteria and were randomly assigned into two groups: Group 1 (conventional PCNL) and Group 2 (tubeless PCNL). Postoperative outcomes, including pain scores, fever, blood loss, urinary leakage, length of hospitalization, need for re-hospitalization, and stone-free rates, were evaluated. Statistical analyses were performed using SPSS version 20.0, with a p-value of less than 0.05 considered statistically significant. Results: A total of 60 patients were included in the final analysis, equally divided into two groups. There were no statistically significant differences between the groups regarding demographic data, stone characteristics, hemoglobin levels, creatinine levels, or blood loss. However, the duration of surgery was significantly longer in the tubeless group (Group 2) compared to the conventional group (Group 1) (P-value = 0.034). Both groups achieved comparable stone-free rates with no significant differences in postoperative complications. Conclusion: Tubeless PCNL is a safe and effective alternative to conventional PCNL for managing renal and ureteral stones, with comparable outcomes in terms of blood loss, creatinine, and hemoglobin levels. The main advantage of tubeless PCNL is the potential for reduced postoperative discomfort and quicker recovery, although it requires a longer operative time. These findings support the use of tubeless PCNL as a viable option in appropriately selected patients, with implications for improving patient outcomes and reducing healthcare costs associated with kidney stone management.

Prospective Randomized Study on the Use of Sentinel Node Biopsy for High-risk Cutaneous Squamous Cell Carcinomas of the Head and Neck.

The use of sentinel lymph node biopsy (SLNB) for high-risk cutaneous squamous cell carcinoma (CSCC) is not yet clearly documented, especially for the head and neck area, due to its rich and cross-branching lymphatic system. We present the first prospective randomized study on the use of SLNB in high-risk CSCCs of the head and neck. Seventy-six patients with high-risk CSCCs of the head and neck were randomly divided into two groups: A (n = 38) and B (n = 38). In group A, SLNB was performed additionally to the excision of squamous cell carcinoma, whereas in group B, only excision of the lesion was performed. The patients were followed up for 5 years postoperatively, and local recurrences, regional metastases (regional lymph nodes), and mortality were documented. One patient of group A, who never attended any follow-up, was excluded. Both groups had similar characteristics regarding Breslow thickness, perineurial invasion, peripheral limits, differentiation, size, previous incomplete excision, age, sex, education, sun exposure, Fitzpatrick score, previous incomplete excision, previous skin cancer, and smoking. Two patients had a positive sentinel lymph node and were submitted to regional lymphadenectomy. We documented deaths (three in group A and two in group B; P = 0.674), local recurrence (seven in group A and six in group B; P = 0.768), and regional metastasis (zero in group A and two in group B; P = 0.159). There is no clear benefit on the use of SLNB in high-risk CSCCs of the head and neck regarding metastasis, mortality, or local recurrence control.

Very early and early nutrition in children with pancreatitis-A randomised trial.

The aim of our study was to assess the impact of the very early introduction of refeeding on the course of acute pancreatitis (AP) in children. Additionally, we evaluated the effect of nutrition on inflammatory markers, including cytokines. This prospective randomised study was conducted in three university hospitals in Poland. Patients, aged 1-18 years with AP, were randomised into two groups: A-refeeding within 24 h of hospital admission (very early), and B-refeeding at least 24 h after admission (early nutrition). The severity of AP was assessed after 48 h. The serum concentrations of four cytokines (tumour necrosis factor α [TNFα], interleukin-1β [IL-1β], interleukin-6 [IL-6] and interleukin-8 [IL-8]) and C-reactive protein, as well as the activity of amylase, lipase and aminotransferases, were measured during the first 3 days of hospitalisation. A total of 94 children were recruited to participate in the study. The statistical analysis included 75 patients with mild pancreatitis: 42-group A and 33-group B. The two groups did not differ in the length of hospitalisation (p = 0.22), AP symptoms or results of laboratory tests. Analysis of cytokine levels was conducted for 64 children: 38-group A and 26-group B. We did not find a difference in concentrations of the measured cytokines, except for IL-1β on the third day of hospitalisation (p = 0.01). The time of initiation of oral nutrition within 24 h (very early) or after 24 h (early) from the beginning of hospitalisation had no impact on the length of hospitalisation, concentrations of TNF-α, IL-1β, IL-6 and IL-8, activity of amylase and lipase or occurrence of symptoms in children with mild AP.

Prospective Randomized Study on the Use of Robot-Assisted Postoperative Visits.

Introduction: Robot-assisted visits, as part of telemedicine, can offer doctors the opportunity to take care of patients. Due to theCOVID-19 pandemic, there has been an increase in telemedicine. The use of teleconsultations, for example, has found its way into the German health care system. However, the practicability and the benefit of robot-assisted postoperative visits have not been systematically investigated in any study worldwide. Methods: Patients were enrolled in a prospective randomized study comparing the standard postoperative visit with the doctor on call and the digital visit through the Double robot between December 2019 and April 2022. All patients and doctors completed a survey after the visit. The primary outcome was patient satisfaction. Secondary outcomes included patients' pain, hospitalization time, and patients' opinions about the usefulness of the robot. Likert scales of arithmetic mean, standard deviation, and subgroup analyses with the Mann-Whitney U test and the Fisher's exact test were used to compare outcomes. Results: We enrolled a total of 106 patients: 54 (50.9%) of them underwent the robot visit and 52 (49.1%) underwent the conventional visit. Baseline demographic and clinical characteristics were similar between groups. Our primary outcome was the same in both arms. Similar results were obtained for the secondary endpoints. Conclusion: Robot-televisits were comparable with standard visits including satisfaction, usefulness, and time of hospitalization. Digitalization in medicine is an irreversible process, especially after the COVID-19 pandemic. We hope that our study will provide concrete help to encourage the allocation of funds for telemedicine in Germany's health care system.

Prospective randomized multicenter study to evaluate holmium vs. new thulium fiber laser for prostate enucleation.

Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes. A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications. Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Q<inf>max</inf>), and post-void residual volume (PVR; P<0.05). At 6 months, mean±SD IPSS, IPSS-QoL, Q<inf>max</inf>, and PVR for HoLEP vs. ThuFLEP were 5.8±4.9 vs. 4.8±5.0 points (P=0.57), 1.6±1.4 vs. 0.7±1.1 points (P=0.09), 29.9±12.5 vs. 29.6±8.0 mL/s (P=0.8), and 16.3±17.7 vs. 15.5±13.4 mL (P=0.92), respectively. No intraoperative complication was recorded. No Clavien-Dindo ≥III complications occurred during hospitalization. After 6 months, 8 (8%) and 6 (6%) patients reported mild stress urinary incontinence in HoLEP and ThuFLEP groups, respectively (P=0.24). Urethral stenosis was observed in 3 men (3%) in the HoLEP group and 1 subject (1%) in the ThuFLEP group (P=0.72). HoLEP and ThuFLEP are effective and safe for BPH treatment, with comparable functional outcomes and complication rates at 6 months. Further research is needed to confirm these findings.

Comparison of the Effectiveness of Injection Laryngoplasty Using Autologous Platelet-Rich Plasma or Autologous Fat With Platelet-Rich Fibrin for the Treatment of Patients With Unilateral Vocal Fold Paralysis

ObjectivesUnilateral vocal fold paralysis (UVFP) can be idiopathic or a result of surgery, cancer or neurological disease. The most common presentation is dysphonia, which causes problems with communication, and can lead to anxiety and depression. Injection laryngoplasty (IL) is a current means of treatment, but there have been few studies to determine the optimal material to use. Therefore, we aimed to compare the use of autologous platelet-rich plasma and autologous fat with platelet-rich fibrin for injection laryngoplasty under local anesthesia and general anesthesia respectively. Study designA prospective randomized controlled study was conducted at the Otolaryngology-Head and Neck Surgery Department, Ramathibodi Hospital, Faculty of Medicine, Mahidol University. MethodsThirty-four patients with UVFP were recruited. All met the inclusion criteria and were randomized to two groups, to be treated using autologous platelet-rich plasma under local anesthesia or autologous fat with platelet-rich fibrin under general anesthesia. The primary outcome was the mean difference in the Voice Handicap Index (VHI) between the groups at 1- and 6-months post. The secondary outcomes were the mean differences in voice acoustic parameters [maximum phonation time (MPT), jitter, shimmer, and harmonic to noise ratio (HNR)] between the groups at these time points. ResultsAt the measured time points, there were no significant differences in the mean VHIs (P=0.462), MPT (P=0.79), jitter (P=0.234), shimmer (P=0.863), or HNR (P=0.096) between the groups. Few people who underwent the procedure under local anesthesia developed laryngospasm while some of those in the fat with platelet-rich fibrin developed postoperative abdominal contusion or hematoma which resolved spontaneously. ConclusionsWe have found no difference in the effectiveness of IL using autologous platelet-rich plasma under local anesthesia or autologous fat with platelet-rich fibrin performed under general anesthesia in patients with UVFP. No serious or life-threatening complications were found in both groups.

Comparison of different head positions for ease of intubation in obese patients using videolaryngoscopy

BackgroundIn direct laryngoscopy ramping is a recommended technique in obese patients to improve success of intubation. Recently 25° back up position has also been described for the same purpose. The effect of change in head neck positions have not been much studied in obese patients, while using videolaryngoscopy (VL). MethodsThis prospective randomized study included 150 adult obese surgical patients (BMI >30 kg/m2), requiring intubation using VL. Patients were randomly assigned one of the three groups: sniffing position, ramped up position and 25° back up position. The time taken for intubation was the primary outcome. Other parameters assessed were Cormack-Lehane grading, time to achieve best glottic view, ease and attempts required for intubation. ResultsThe study shows that, 25° back up position has reduced time taken for successful intubation 161.80 s as compared to ramped up position (172.56 s) and sniffing position (171.84 s) with p value of <0.0001. Mean time for best glottic view was 18.82 s in group C, compared to 38.24 s for group B, and 39.66 s in group A (p < 0.0001). The ease of intubation score was also very easy/easy in 9/28 patients in group C compared to 3/16 and 3/17 patients respectively in groups A and B (p = 0.007). First attempt at intubation was successful in 47 patients in group C compared to 32 and 40 patients in groups A and B respectively (p = 0.001). There was no significant difference in Cormack and Lehane grading in different positions. ConclusionsThe 25° back up position is a simple and useful technique in improving glottic view and intubation success rate with reduction in intubation time compared to ramped up and sniffing positions.

Romiplostim in chemotherapy-induced thrombocytopenia: A review of the literature.

Chemotherapy-induced thrombocytopenia (CIT) is a common challenge of cancer therapy and can lead to chemotherapy dose reduction, delay, and/or discontinuation, affecting relative dose intensity, and possibly adversely impacting cancer care. Besides changing anticancer regimens, standard management of CIT has been limited to platelet transfusions and supportive care. Use of the thrombopoietin receptor agonist romiplostim, already approved for use in immune thrombocytopenia, has shown promising signs of efficacy in CIT. In a phase 2 prospective randomized study of solid tumor patients with platelet counts <100 × 109/L for ≥4 weeks due to CIT, weekly romiplostim corrected the platelet count to >100 × 109/L in 93% (14/15) of patients within 3 weeks versus 12.5% (1/8) of untreated patients (p < 0.001). Including patients treated with romiplostim in an additional single-arm cohort, 85% (44/52) of all romiplostim-treated patients responded with platelet count correction within 3 weeks. Several retrospective studies of CIT have also shown responses to weekly romiplostim, with the largest study finding that poor response to romiplostim was predicted by tumor invasion of the bone marrow (odds ratio, 0.029; 95% CI: 0.0046-0.18; p < 0.001), prior pelvic irradiation (odds ratio, 0.078; 95% CI: 0.0062-0.98; p = 0.048), and prior temozolomide treatment (odds ratio 0.24; 95% CI: 0.061-0.96; p = 0.043). Elsewhere, lower baseline TPO levels were predictive of romiplostim response (p = 0.036). No new safety signals have emerged from romiplostim CIT studies. Recent treatment guidelines, including those from the National Comprehensive Cancer Network, now support consideration of romiplostim use in CIT. Data are expected from two ongoing phase 3 romiplostim CIT trials.

Modified Sodium hyaluronate conjugated to riboflavin (Har® 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study

BackgroundThis study evaluates the therapeutic efficacy of HAr® (a novel ophthalmic solution containing modified hyaluronic acid covalently linked to riboflavin) compared to hyaluronic acid eye drops in patients with dry eye disease (DED). MethodsSixteen consecutive patients with bilateral medium to severe DED were divided into two groups. Group 1 received HAr® 0.1 % (Ribohyal®), while Group 2 received HA 0.1 % eye drops. Parameters such as Ocular Surface Disease Index (OSDI) score, osmolarity, break-up time (BUT), non-invasive BUT (NIBUT), tear meniscus measurement, Schirmer test, and Oxford Staining were evaluated. This study has been successfully registered on ClinicalTrials.gov public (Identifier NCT06122428) ResultsThe Ribohyal group showed faster improvement in OSDI scores, with a statistically significant difference at 2 h (mean classification difference: −51.75; p = 0.0003). Photophobia significantly reduced at 2 h, 4 weeks, and 8 weeks in the Ribohyal group compared to baseline (p < 0.0001). Osmolarity improved significantly after 8 weeks in both groups (p < 0.0001). ConclusionsHAr® 0.1 % (Ribohyal®) effectively reduced DED symptoms and improved photophobia within 2 h of instillation, lasting up to 8 weeks.

Phase I Study of Intravitreal Injection of Autologous CD34+ Stem Cells from Bone Marrow in Eyes with Vision Loss from Retinitis Pigmentosa

PurposeTo evaluate the feasibility and safety of intravitreal injection of autologous CD34+ stem cells from bone marrow (BMSCs) in eyes with vision loss from retinitis pigmentosa (RP). DesignPhase I prospective open-labeled single center study. ParticipantsSeven eyes (7 patients) with RP with best corrected visual acuity (BCVA) of 20/100 to 20/400 or visual field constriction to within 10 degrees. MethodsA comprehensive exam with ETDRS BCVA, macular optical coherence tomography, perimetry, fluorescein angiography was performed at baseline, 1 to 3 months, and 6 months after study treatment. Bone marrow aspiration, isolation of CD34+ BMSCs under Good Manufacturing Practice (GMP) conditions, and intravitreal cell injection were performed on the same day. The CD34+ cells were isolated from bone marrow using a Ficoll gradient and the Miltenyi CliniMACs system. Isolated CD34+ cells were released for clinical use if viability, sterility and purity met the release criteria accepted by the Food and Drug Administration for this clinical study. Main Outcome MeasuresNumber of CD34+ cells isolated for injection and adverse events associated with study treatment during follow-up. Secondary outcome measures are changes in BCVA and perimetry. ResultsAll isolated CD34+ cells passed the release criteria. A mean of 3.26 + 0.66 million viable CD34+ cells (range 1.6 to 7.05 million) were injected intravitreally per eye. No adverse event was noted during the study follow-up except for one participant who was noted with transient cells in the anterior chamber with mild elevation in intraocular pressure at 18 hours after study injection which normalized by 24 hours. BCVA remained within 2 lines of baseline or improved in all participants at 6 months follow-up. Perimetry was stable or improved in all eyes during study follow-up except one eye with transient improvement at 1 month and worsening of both eyes at 6 months. ConclusionIntravitreal injection of autologous CD34+ BMSCs is feasible and appears to be well tolerated in eyes with vision loss from RP. A larger randomized prospective study would be needed to evaluate further the safety and potential efficacy of this cell therapy for vision loss associated with RP.

The Effects of Axis-flip of the Refractive Cylinder on vision and patient reported outcome measures following Toric Intraocular Lens implantation.

To investigate the effects of cylinder axis-flip following toric intraocular lens (TIOL) implantation on vision and patient reported outcome measures (PROMs). Teaching hospital in the United Kingdom. Post-hoc analysis of data from patients who participated in a prospective randomised study of TIOLs. Axis-flip was defined as a change in post-operative refractive cylinder axis of 900 +/- 22.50 from the pre-operative biometric axis. Uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), residual refractive cylinder (RC), and CATPROM-5 and EQ5D3L quality of life (QOL) scores were analysed. At 6 months, axis flip occurred in 29 (34.5%) of 84 eyes, of which 28 had with-the-rule astigmatism (WTR) pre-operatively. Mean (+/-standard deviation) UDVA (logMAR) was 0.13 (0.16) in flipped cases (FC) and 0.10 (0.14) in un-flipped cases (UF) (p=0.88). BDVA was 0.01 (0.11) in FC and was 0.00 (0.09) in UF (p=0.68). Mean RC was 0.74 dioptres (D) (0.41) in FC and 0.93D (0.47) in UF (p=0.08). Mean CATPROM-5 score was -6.22.98 (2.56) in FC and -5.52 (3.03) in UF (p=0.29). Mean EQ5D3L calibrated score was 0.89 (0.19) in FC and 0.85 (0.19) in UF (p=0.35). Retrospectively applying coefficients of adjustment to account for posterior corneal astigmatism (PCA), suggested that 6 eyes (21%) of FC with WTR might have avoided axis-flip. Axis flipping following TIOL implantation did not adversely influence visual acuity or PROMs scores. Most FC had WTR pre-operatively. Adjusting for PCA might have reduced axis flip in some of these eyes.

Anastomotic bleeding from invaginated pancreaticogastrostomy following pancreatoduodenectomy: incidence, risk factors, treatment and prevention.

Meta-analysis of 10 randomized prospective trials demonstrated a higher risk of postoperative bleeding from pancreaticogastrostomy (PG) compared with pancreatojejunostomy following pancreatoduodenectomy (PD). This study evaluated the incidence, risk factors, and treatment of anastomotic bleeding from invaginated PG. We retrospectively evaluated all consecutive PDs performed between April 1, 2011 and December 31, 2022 using invaginated PG by the double purse-string technique. Multivariate analysis identified risk factors for anastomotic PG bleeding. During the study, 695 consecutive patients with a median age of 66 years underwent PD; the majority was performed for ductal pancreatic adenocarcinomas. Simultaneous vascular resections were performed in 328 patients. Postoperative mortality was 4.1%. Bleeding from PG occurred in 33(4.6%) patients at a median interval of 5 days (range, 1-14) from surgery, leading to reoperation in 21(63%). PG bleeding-related mortality was 9.0%. Multivariate analyses identified a soft pancreatic texture and Wirsung duct > 3 or ≤ 3mm (Class C and D, respectively, of the ISGPS) (odds ratio [OR]: 2.17, 95% confidence interval [95% CI]: 1.38-3.44; P = 0.0009) and wrapping of the invaginated pancreas (OR: 0.37, 95% CI: 0.17-0.84; P = 0.01) as independent risk factors for PG bleeding. In a large volume setting, anastomotic bleeding from invaginated PG occurred in ~ 5% of patients and was associated with soft pancreatic parenchyma and small wirsung duct. The reduced rate of PG bleeding observed with wrapping of the invaginated pancreatic stump warrants further evaluation in a prospective randomized study.

Voluminous hiatal hernias – the role of robotic surgery

Abstract Robotic surgery has become increasingly prevalent in UGI surgery over the last decade, particularly for treating hiatal hernias. Voluminous hiatal hernias, defined as the herniation of 30–50 % of the stomach into the thorax, often require surgical intervention due to associated dysphagia and potential severe complications. Given the challenges of repairing voluminous hiatal hernias, especially in elderly and fragile patients, the surgical technique should be optimal. Robotic surgery affords excellent visualization, allowing high mediastinal dissection and precise hiatus reconstruction. Despite the clear technical advantages, it remains to be demonstrated if the robotic approach matches the outcomes of conventional laparoscopic techniques. We review here the fundamentals of hiatal hernia surgery and describe our surgical technique using the da Vinci Xi robot to operate voluminous hiatal hernias. Additionally, we performed a systematic research analysis and selected recent publications focusing on robotic surgery for voluminous hiatal hernias. Recent studies report comparable complication rates, recurrence, and hospital stay lengths between robotic and laparoscopy surgery. Initial robotic procedures had longer operative times, which decreased with surgeon experience. Most of the studies were observational and retrospective, reporting the experience of a single center. Robotic surgery appears to be a viable option with similar complications rates to laparoscopic surgery under optimized conditions. Current literature supports the broader adoption of robotic surgery for voluminous hiatal hernias. However, prospective randomized studies are needed to further validate its use.

Transiliac-Transsacral Screw Fixation is Superior to Lumbopelvic Stabilization in the Treatment of Minimally Displaced Sacral H-/U-Type Fragility Fractures.

Retrospective Cohort Study. To compare the outcomes and complications of transiliac-transsacral screw fixation (TIS) and lumbopelvic fixation (LPS), the 2 most common fixation methods for nondisplaced and minimally displaced H-/U- type sacral fragility fractures. Medical records of patients treated with TIS or LPS for nondisplaced and minimally displaced H-/U-type sacral fragility fractures at 2 level A trauma centers between 2012 and 2022 were analyzed. Postoperative low back pain and mobility levels were assessed as primary outcomes before discharge and at 6weeks and 6months postoperatively. Surgery time, blood loss, and surgical complication rates were assessed as secondary outcomes. Statistical analyses consisted of Fisher's exact tests for frequency distributions and Mann-Whitney-U tests and t-tests for group comparisons. 52 patients undergoing TIS (mean age: 78 ± 9years) and 36 patients undergoing LPS (74 ± 10years) with no discrepancy in demographic parameters were identified. There were no differences in low back pain levels between the 2 groups before surgery, before discharge, at 6weeks postoperatively, and at 6months postoperatively (P > 0.05). There were no differences in mobility levels before surgery, before discharge, at 6weeks postoperatively, and at 6months postoperatively (P > 0.05). Duration of surgery was shorter after TIS (36 ± 13min) compared to LPS (113 ± 31min) (P < 0.0001). Intraoperative blood loss was lower for TIS (median <20mL) compared to LPS (median 125mL) (P < 0.0001). Postoperative radiculopathy was less frequent after TIS (n = 1) compared to LPS (n = 3) (P > 0.05). Median length of stay was shorter after TIS (11days) compared to LPS (14days) (P < 0.05). Rates of reoperations directly related to the index surgery were lower after TIS (n = 2) compared to LPS (n = 10) (P < 0.01). Implant failures were observed only after LPS (n = 1). Patients with nondisplaced and minimally displaced H-/U- type sacral fragility fractures may preferably be treated using TIS, as it is equivalent to LPS in terms of low back pain reduction and restoration of mobility, but allows for shorter operative time, less blood loss and lower reoperation rates. Prospective randomized studies should be conducted to substantiate our findings and develop distinct treatment recommendations.

Comparable bone penetration between antibiotic-loaded and plain bone cement in total knee arthroplasty.

One of the main concerns around the use of antibiotic-loaded bone cement (ALBC) is the potential reduction in the mechanical properties of the cement when antibiotics are admixed. The purpose of this study was to determine whether there is a difference between plain cement and ALBC in terms of radiological intrusion into the bone in total knee arthroplasties (TKAs). Prospective randomized study of 80 consecutive patients who underwent TKA. Depending on the cement used, patients were divided into two groups by a computer-generated randomization programme: the cement without antibiotic (Group 1) or the ALBC (Group 2). Cement intrusion was measured in postoperative radiographs in eight different regions in the tibial component and six regions in the femoral component. The average cement intrusion was similar in both groups (p = nonsignificance [n.s.]). Group 1 (plain cement) had an average cement intrusion in the femur of 1.4 mm (±0.4) and 2.4 mm (±0.4) in the tibia. In Group 2 (ALBC), the average cement intrusion in the femur came to 1.6 (±0.5) and 2.4 mm (±0.5) in the tibia. In 80% of the patients, the cement intrusion in the tibia averaged a minimum of 2 mm, being similar in both groups (p = n.s.). There are no differences in bone intrusion when comparing plain cement to ALBC. Therefore, the use of ALBC in primary TKA may be indicated, achieving optimal bone penetration. Level I.