Prospective Nonrandomized Study Research Articles

The effect of adhesiolysis on stoma takedown in patients with end colostomy

AIM: the optimal extent of adhesiolysis for stoma takedown after Hartmann’s procedure is still unknown. This study is for evaluation the early and late results after partial and total dissection of adhesions during Hartmann’s reversal (HR).PATIENTS AND METHODS: a prospective non-randomized study included 99 patients with end colostomy. Fifty patients were included in the main group, in which partial adhesiolysis was performed during HR, and 49 — were the control group, in which complete dissection of adhesions was performed. The groups did not differ in the basic demographic characteristics, number of previous operations, and the severity of the adhesions.RESULTS: the operation time in the groups of partial and total adhesiolysis was 222 vs 205 minutes, respectively (p = 0.9). Injury of the intestinal wall occurred in 18 patients in the main group, and in 19 controls (p = 0.8). The postoperative stay was 12 in the main group vs 11 in the control (p = 0.7). The morbidity rate in the main group was 42% (n = 21), in controls — 29% (n = 14) (p = 0.2). Reoperations were performed in 4 patients of the main group, no reoperations in the control group were required, but no significant differences were obtained (p = 0.5). In the group of partial adhesiolysis, 1 fatal outcome was registered. By the regression analysis, the only factor increasing the likelihood of postoperative complications was a BMI > 35 kg/m2 (OR = 5.3; 95% CI: 1.5–21.2; p = 0.01).CONCLUSION: total adhesiolysis does not affect the operation time and traumatism of Hartmann reversal, does not increase morbidity rate.

ВОЗМОЖНОСТИ ТЕРАПИИ КАШЛЯ У ДЕТЕЙ

Acute respiratory infections (ARI) are the main reason for morbidity in childhood. In ca. 90% of cases, they are accompanied by cough. The purpose of this research was to study the effectiveness and safety of the STODAL® drug in the treatment of cough in children. Materials and methods used: a multicenter prospective observational non-randomized clinical study was conducted involving 1000 outpatients with ARI aged 2 to 7 y/o and whose cough duration did not exceed 3 days from the onset of the disease. All of them were prescribed and treated with the complex homeopathic anticough drug on the day of their visit to pediatric practitioner in the outpatient hospital facilities. The patients were divided into two age groups as follows: G1 (n=500) of children aged 2 to 4 y/o and G2 (n=500) of children aged 4 years and 1 day old to 7 y/o. Results: on the 7th day of the therapy, a statistically significant decrease in the severity of daytime cough was noted: in G1 the severity of cough decreased by 1.51 points (from 2.16 to 0.65 points, p<0.001) and by 1.56 points (from 2.24 to 0.68 points, p<0.001) in G2. There was no difference in the reduction in daytime cough severity between the groups (p=0.158). The severity of night cough in G1 decreased by 1.16 points (from 1.64 to 0.48 points, p<0.001) and by 1.25 points (from 1.71 to 0.46 points, p<0.001) in G2. There were no differences in the dynamics of the severity of night cough between the groups as well (p=0.135). The proportion of patients whose cough resolved completely or became clinically insignificant on the 7th day of treatment was 98%, these patients were therefore considered recovered. Cough treatment was rated positively by 95.1% of parents/caretakers. Adverse events (AEs) were reported in 5 patients (0.5% of all cases) and there were no serious AEs among them. Conclusion: the effectiveness and safety of the STODAL® drug in the treatment of cough in ARI in children aged 2 to 7 y/o allows recommending a homeopathic drug with complex anti-inflammatory, antitussive and antimicrobial action for its inclusion in the treatment regimens starting from the first days of the disease.

Biomarkers of inflammation and coagulation after minimally invasive mitral valve surgery: a prospective comparison to conventional surgery

STRUCTURED ABSTRACT Objectives Minimally invasive cardiac surgery techniques are increasingly used but have longer cardiopulmonary bypass time, which may increase inflammatory response and negatively affect coagulation. Our aim was to compare biomarkers of inflammation and coagulation as well as transfusion rates after minimally invasive mitral valve repair and mitral valve surgery using conventional sternotomy. Design A prospective non-randomized study was performed enrolling 71 patients undergoing mitral valve surgery (35 right mini-thoracotomy and 36 conventional sternotomy procedures). Blood samples were collected pre- and postoperatively to assess inflammatory response. Thromboelastometry (ROTEM) was performed to assess coagulation, and transfusion rates were monitored. Results The minimally invasive group had longer cardiopulmonary bypass times compared to the sternotomy group: 127 min ([115–146] vs 79 min [65–112], p < 0.001) and were cooled to a lower temperature during cardiopulmonary bypass, 34 °C vs 36 °C (p = 0.04). IL-6 was lower in the minimally invasive group compared to the conventional sternotomy group when measured at the end of the surgical procedure, (38 [23–69] vs 61[41–139], p = 0.008), but no differences were found at postoperative day 1 or postoperative day 3. The transfusion rate was lower in the minimally invasive group (14%) compared to full sternotomy (35%, p = 0.04) and the chest tube output was reduced, (395 ml [190-705] vs 570 ml [400–1040], p = 0.04). Conclusions Our data showed that despite the longer use of extra corporal circulation during surgery, minimally invasive mitral valve repair is associated with reduced inflammatory response, lower rates of transfusion, and reduced chest tube output.

Final analyses of the prospective controlled trial on the efficacy of uracil and tegafur/leucovorin as an adjuvant treatment for stage II colon cancer with risk factors for recurrence using propensity score-based methods (JFMC46-1201).

The efficacy of adjuvant chemotherapy for high-risk stage II colon cancer (CC) has not been well established. Using propensity score matching, we previously reported that the 3-year disease-free survival (DFS) rate was significantly higher in patients treated with uracil and tegafur plus leucovorin (UFT/LV) against surgery alone. We report the final results, including updated 5-year overall survival (OS) rates and risk factor analysis outcomes. In total, 1902 high-risk stage II CC patients with T4, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, and/or < 12 dissected lymph nodes were enrolled in this prospective, non-randomized controlled study based on their self-selected treatment. Oral UFT/LV therapy was administered for six months after surgery. Of the 1880 eligible patients, 402 in Group A (surgery alone) and 804 in Group B (UFT/LV) were propensity score-matched. The 5-year DFS rate was significantly higher in Group B than in Group A (P = 0.0008). The 5-year OS rates were not significantly different between groups. The inverse probability of treatment weighting revealed significantly higher 5-year DFS (P = 0.0006) and 5-year OS (P = 0.0122) rates in group B than in group A. Multivariate analyses revealed that male sex, age ≥ 70years, T4, < 12 dissected lymph nodes, and no adjuvant chemotherapy were significant risk factors for DFS and/or OS. The follow-up data from our prospective non-randomized controlled study revealed a considerable survival advantage in DFS offered by adjuvant chemotherapy with UFT/LV administered for six months over surgery alone in individuals with high-risk stage II CC. Japan Registry of Clinical Trials:jRCTs031180155(date of registration: 25/02/2019), UMIN Clinical Trials Registry:UMIN000007783 (date of registration: 18/04/2012).

Aneurysm Sac Shrinkage at 1 Year after Fenestrated-Branched Endovascular Aortic Repair of Complex Aortic Aneurysms Offers Mid-Term Survival Advantage

To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAA) or thoracoabdominal aortic aneurysms (TAAA). We reviewed the clinical data of patients enrolled in a prospective non-randomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography (CT) scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter (MAD) from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5mm) or failure to regress (<5mm or expansion) according to sac diameter change. Primary endpoint was all-cause mortality. Secondary endpoints were aortic-related mortality (ARM), aortic aneurysm rupture (AAR) and aorta-related secondary intervention. There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean 74±8 years-old) with sequential CT imaging were investigated. Aneurysm extent was TAAA in 328 (71%) patients and CAAA in 135 (29%). Sac shrinkage occurred in 270 (58%) patients and failure to regress in 193 (42%) patients, including 19 (4%) patients with sac expansion at 1-year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73±8 vs. 75±8 years-old; P<.001). Median follow-up was 38 months (interquartile range, 18-51 months). Five-year survival estimate was 69%±4.1% for sac shrinkage and 46%±6.2% for failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P=.005). Five-year cumulative incidences of ARM (1.1% vs. 3.1%, P=.30), AAR (0.6% vs. 2.6%, P=.20) and aorta-related secondary intervention (17±2.8% vs. 19±3.8%) were both comparable between the groups. Aneurysm sac shrinkage at 1 year is frequent after FB-EVAR and is associated with improved patient survival, while sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for non-aortic-related death.

Laminoplasty Versus Laminectomy and Posterior Fusion for Cervical Myelopathy: A Meta-analysis of Radiographic and Clinical Outcomes.

Meta-analysis. This meta-analysis investigates the outcomes of laminoplasty (LP) and laminectomy with fusion (LF) to guide effective patient selection for these two procedures. While LF traditionally offers the ability for excellent posterior decompression, it may alter cervical spine biomechanics and increase the risk of adjacent segment degeneration. LP aims to preserve the natural kinematics of the spine but has not been universally accepted, and may be associated with inadequate decompression, neck pain, and recurrent stenosis. PubMed, Cochrane, and Google Scholar (Pages 1-20) were searched up until March 2024. The outcomes studied were surgery-related outcomes (operating room (OR) time, estimated blood loss (EBL), and length of stay (LOS)), adverse events (overall complications, C5 palsy, and reoperations), radiographic outcomes (cervical lordosis (CL), cervical sagittal vertical axis (cSVA), and T1 slope angle (T1SA)), and patient-reported outcome measures (PROMs) (Neck Disability Index (NDI), Visual Analog Scale (VAS) for neck pain, and Japanese Orthopaedic Association (JOA)). Twenty-two studies were included in this meta-analysis, of which 19 were retrospective studies, two were prospective non-randomized studies, and one was a randomized controlled trial. A total of 2,128 patients were included, with 1,025 undergoing LP and 1,103 undergoing LF. LP patients experienced significantly shorter OR time (P=0.009), less EBL (P=0.02), a lower rate of overall complications (P<0.00001) and C5 palsy (P=0.003), a lower T1SA (P=0.02), and a lower NDI (P=0.0004). No significant difference was observed in the remaining outcomes. This meta-analysis demonstrates that for cervical myelopathy, LP has the benefits of shorter OR time, less EBL, and reduced incidence of C5 palsy as well as overall complication rate. Given these findings, LP remains an important surgical option with a favorable complication profile in patients with cervical myelopathy, although careful patient selection is still paramount in choosing the right procedure for individual patients.

Percutaneous endobiliary radiofrequency ablation with stent placement in type IV hilar cholangiocarcinoma: A prospective comparison with stent placement alone

ObjectivesThis study aimed to compare the safety and effectiveness of percutaneous endobiliary radiofrequency ablation with stent placement (RFA group) versus stent placement alone (stent group) in patients with type IV hilar cholangiocarcinoma. MethodsThis prospective nonrandomized study was conducted between October 2021 and April 2023. The study included 56 participants (33 men and 23 women, median age 73 years) who underwent percutaneous endobiliary RFA with stent placement (n = 25) or stent placement alone (n = 31) for type IV hilar cholangiocarcinoma. The primary end point was stent patency, while the secondary end points were procedure-related adverse events (AE) and overall survival. ResultsThe percutaneous endobiliary RFA and/or stent placement were successfully completed in all patients in both groups. The median stent patency rate was higher in the RFA group than the stent group (188 days vs. 155 days, p = 0.048). There were no differences in AEs (grade 1 [5 in RFA group vs. 5 in stent group, p = 0.74] and grade 2 AEs [2 vs. 4, p = 0.68]) and patients’ survival (median 222 days vs. 214 days, p = 0.49) between the two groups. ConclusionsIn patients with type IV hilar cholangiocarcinoma, percutaneous endobiliary RFA with stent placement may improve stent patency without increasing the risk of AEs compared to stent placement alone.

Prospective Outcomes of Microlaryngoscopy Versus Office Laser Photoangiolysis for Vocal Fold Polyps.

The objective of this study is to compare treatment outcomes for vocal fold polyps (VFPs) between operating room microlaryngoscopy and office-based photoangiolysis with the potassium titanyl phosphate (KTP) laser. Prospective nonrandomized cohort study of patients with VFPs undergoing microlaryngoscopy ("OR group") or KTP laser photoangiolysis ("KTP group"). Voice outcomes (patient-reported outcome measures [Voice Handicap Index-10 (VHI-10) and Singing VHI-10 (SVHI-10)], auditory-perceptual measures [Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)], videostroboscopic characteristics [Voice-Vibratory Assessment of Laryngeal Imaging (VALI)], and acoustic and aerodynamic measures) were performed at baseline and regular intervals after intervention. Forty-four subjects (17 OR group, 27 KTP group) with VFPs were enrolled. Mean VHI-10 significantly improved from baseline to each follow-up interval in both groups, except for the 1-2-week interval in the OR group. Mean SVHI-10 improved for both groups at some intervals. Growth curve models and time-to-event analyses for patient-reported outcomes did not differ between groups. There were significant improvements in all categories of auditory-perceptual voice quality and some categories of videostroboscopic characteristics in both groups. No significant trends were identified in acoustic and aerodynamic measures. Improvements in most outcomes did not significantly differ between groups or based on polyp size. There were no major complications. Significant improvements in patient-reported voice outcomes measures, auditory-perceptual voice evaluation, and videostroboscopic characteristics occur following surgical treatment of vocal fold polyps with either microlaryngoscopy or office-based KTP laser. Long-term voice outcomes do not significantly differ between treatment modalities. Level 3 Laryngoscope, 2024.

Real-World Patent Foramen Ovale (PFO) Closure in Japan - 30-Day Clinical Outcomes From the AmplatzerTM PFO Occluder Japan Post-Marketing Surveillance Study.

The AmplatzerTM PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.Methods and Results: PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the AmplatzerTM PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure. In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the AmplatzerTM PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.

Comparison of surgical outcomes between Kahook Dual Blade goniotomy and Trabectome surgery in patients with open-angle glaucoma

Objective: To compare the medium-term therapeutic effects of Kahook Dual Blade (KDB) goniotomy and Trabectome surgery in the treatment of patients with primary open-angle glaucoma (POAG). Methods: This study was a non-randomized prospective interventional controlled clinical study. POAG patients who underwent KDB goniotomy or Trabectome surgery at Beijing Tongren Hospital from May 2017 to April 2022 were enrolled. The definition of successful surgery was postoperative average intraocular pressure (IOP)≤21 mmHg (1 mmHg=0.133 kPa) and IOP decrease≥20%. Follow-up visits were conducted on the 1st day, 1st week, 1st, 3rd and 6th month after surgery. The IOP value, the number of IOP-lowering medications, the proportion of surgical success (average IOP≤21 mmHg at 6 months), and complications were evaluated. Statistical methods included independent sample t-test, Mann-Whitney rank sum test, χ2 test, repeated measures two-factor analysis of variance, Bonferroni, Friedman M test, Wilcoxon, and Log-rank. The Kaplan-Meier method was used to calculate the cumulative success rate of each group. Results: Seventeen male patients (17 eyes) and 10 female patients (10 eyes) were included. The mean age was (39.9±17.7) years old. There were 11 patients in the KDB group and 16 patients in the Trabectome group. There was no significant difference in clinical baseline conditions between the two groups (P>0.05). The IOPs in the KDB and Trabectome groups at postoperative 1 week [(16.6±6.3) and (16.4±4.1) mmHg) and 6 months [(17.8±5.3) and (19.9±4.4) mmHg) were lower than those before surgery [(25.1±9.3) and (27.4±9.1) mmHg) (all P<0.05). There was no significant difference in the overall IOP between groups (P>0.05). The IOP reduction rates in the KDB and Trabectome groups were 23.4% and 19.0%, with no significant difference (P=0.674). The numbers of IOP-lowering medications used in the KDB and Trabectome groups at 3 months [2.0 (1.0, 4.0) and 2.0 (1.0, 2.3)] and 6 months [2.0 (0.0, 4.0) and 2.0 (1.0, 3.0)] after surgery were not significantly different from those before surgery [4.0 (2.0, 4.0) and 3.0 (2.0, 4.0)] (both P>0.05). There was no statistical significance in the overall number of IOP-lowering medications used between the two groups (P>0.05). There was also no statistically significant difference in the proportion of patients with an IOP decrease of≥20% and the proportion of patients whose mean postoperative IOP was≤21 mmHg (all P>0.05). The proportions of IOP≤21 mmHg in the KDB group and the Trabectome group at 6 months after surgery were 81.8% and 68.8% (P>0.05). Serious intraoperative or postoperative complications occurred in neither group. Conclusions: Both KDB trabeculotomy and Trabectome surgery can effectively reduce IOP and have a good safety profile in treating POAG, with the same number of IOP-lowering medications.

Long-term clinical and radiographic outcomes of arthroscopic acromioclavicular stabilization for acute acromioclavicular joint dislocation.

Standard open acromioclavicular (AC) stabilization is associated with increased postoperative complications including deltoid injury, infection, tunnel complications, loss of reduction, and wound/cosmetic concerns. Arthroscopy may offer superior visualization and advantages that limit these risks. The aim of this prospective non-randomized study is to evaluate advantages and long-term reliability of arthroscopic AC stabilization. Thirty-two patients with acute grade III, IV and V AC dislocations underwent arthroscopic AC reconstruction with long-term assessment by clinical AC examination, Simple Shoulder Test, American Shoulder and Elbow Surgeons scores, visual analog scale, Specific AC Score and Quick Disabilities of the Arm, Shoulder and Hand scores. Radiographs verified conservation of initial reduction and presence of coracoclavicular (CC) ossifications. Complications, revision rate, and satisfaction were assessed and compared to the literature. Mean follow-up time was 67.6 months. All clinical outcome scores improved and differences were statistically significant (P<0.001). Initial postoperative radiographs consistently showed complete reduction. Two patients experienced relapse to grade II AC dislocation without clinical implications. In total, 71.8% showed CC ossifications without functional impairment, and in 31.3% concomitant injuries were observed. Reintervention rate was 9.4%, and 96.9% of patients were satisfied with procedure outcomes. Arthroscopic stabilization for acute AC joint dislocations offers satisfactory clinical and radiographic outcomes, and our results show that the arthroscopic technique is reliable in the long run. We report better reduction in maintenance, fewer complications, and similar reoperation rates compared to other techniques. Level of evidence: III.

Evaluation of the effectiveness of a new surgical correction method for combined pelvic organ prolapse in women of reproductive age: A prospective non-randomized study

Aim. To evaluate the effectiveness of combined pelvic organ prolapse correction using the proposed modification of laparoscopic promontofixation of the uterus and vaginal walls using a mesh graft in women of reproductive age. Materials and methods. A prospective non-randomized study included 41 women of reproductive age (up to 49 years) with grade II–IV symptomatic combined pelvic organ prolapse. The main group (n=19) included women who underwent surgery using the proposed original method (invention patent No. RU2795649C1 dated October 27, 2022), the control group (n=22) included women who underwent conventional laparoscopic promontofixation of the uterus and vaginal walls and vaginal plasty with local tissues. The duration of surgery, intraoperative blood loss, anatomical result, effect on symptoms and sexual function were assessed using the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Results. The duration of surgery and intraoperative blood loss were significantly lower in the main group (p=0.043 and p0.001, respectively). Anatomical success was achieved in both groups and persisted throughout the follow-up period (without statistically significant differences). Analysis of the PFDI-20 questionnaire responses showed a significant improvement in both groups with no statistically significant differences. Analysis of the PISQ-12 questionnaire data showed a significant improvement in the quality of sexual life in both groups; however, after a year of follow-up, patients of the main group had a significantly better quality of sexual life (p0.05). Conclusion. The surgical correction of combined pelvic organ prolapse using the proposed method demonstrated a good anatomical result, a decrease in intraoperative blood loss and duration of surgery, as well as an improvement in sexual function in women of reproductive age.

Clinical efficacy of complex antioxidant therapy for pelvic varicose veins in women: A prospective non-randomized controlled study

Aim. To evaluate the clinical efficacy of complex antioxidant therapy (CAT) in the treatment of patients with pelvic varicose veins (PVV). Materials and methods. Patients with PVV (n=150) were divided into groups 1 and 2 of 75 subjects; the groups were comparable. Treatment in both groups included standard therapy with one of the venotropic agents (60 days). Patients of group 1 additionally received CAT for 30 days (1 course), in total 3 courses with 2-month intervals. Results. When assessing the parameters of the lipoperoxidation system (antioxidant protection) in group 1 during CAT combined with standard venotropic therapy, there was a statistically significant decrease in the levels of lipid hydroperoxides (p0.0001), diene conjugates (p=0.001), malonic dialdehyde (p0.0001), an increase in the levels of catalase (p0.0001), superoxide dismutase (p0.0001), glutathione peroxidase (p0.0001), glutathione reductase (p0.0001), glutathione-S-transferase (p=0.002) and the reduced glutathione content (p=0.032) compared to levels before treatment. The above group showed a decrease in the diameter of the pelvic varicose veins: internal iliac (p0.001), ovarian (p0.0001) and arcuate (p0.001), an increase in their blood flow velocity (p=0.003, 0.041, and 0.040, respectively), a decrease in the duration of retrograde flow to 0.3 cm. There was a decrease in pelvic pain (p0.0001), dysmenorrhea (p=0.024), dyspareunia (p=0.037), the frequency of irregular menstruation (p=0.031), an improvement in quality of life (p=0.047), pregnancy rate (p=0.013), the number of live births (p=0.004), and the duration of remission (p=0.047). Conclusion. The use of a combination of antioxidants superoxide dismutase 250 mg 2 times a day, acetyl-glutathione at 100 mg 2 times a day, and astaxanthin 400 mg/day for 30 days in 3 courses with 2-month intervals combined with venotropic therapy can significantly improve the treatment outcomes of patients with PVV.

Clinical effectiveness of drop-in mental health services at paediatric hospitals: A non-randomised multi-site study for children and young people and their families - study protocol.

Despite the high prevalence of mental health difficulties in children and young people with long-term health conditions (LTCs), these difficulties and experiences are often overlooked and untreated. Previous research demonstrated the effectiveness of psychological support provided via a drop-in mental health centre located in a paediatric hospital. The aim of this prospective non-randomised single-arm multi-centre interventional study is to determine the clinical effectiveness of drop-in mental health services when implemented at paediatric hospitals in England. It is hypothesised that families who receive psychological interventions through the drop-in services will show improved emotional and behavioural symptoms. Outcomes will be measured at baseline and at 6-month follow-up. The primary outcome is the difference in the total difficulties score on the Strengths and Difficulties Questionnaire (SDQ) reported by parent or child at 6 months. Secondary outcomes include self and parent reported Paediatric Quality of Life Inventory (PedsQL), self-reported depression (PHQ-9) and anxiety measures (GAD-7) and family satisfaction (CSQ-8). This trial aims to determine the clinical effectiveness of providing psychological support in the context of LTCs through drop-in mental health services at paediatric hospitals in England. These findings will contribute to policies and practice addressing mental health needs in children and young people with other long-term health conditions. ISRCTN15063954, Registered on 9 December 2022.

Aquablation versus HoLEP in patients with benign prostatic hyperplasia: a comparative prospective non-randomized study

PurposeThe question of best surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) remains controversial. We compared the outcomes of aquablation and holmium laser enucleation of the prostate ("HoLEP") in a prospective cohort.MethodsPatients with BPH underwent aquablation or HoLEP according to their preference between June 2020 and April 2022. Prostate volume (“PV”), laboratory results, postvoid residual volume, uroflowmetry, IPSS, ICIQ-SF, MSHQ-EjD, EES and IIEF were evaluated preoperatively and at three, six and 12 months postoperatively. We also analyzed perioperative characteristics and complications via the Clavien Dindo („CD“) classification.ResultsWe included 40 patients, 16 of whom underwent aquablation and 24 HoLEP. Mean age was 67 years (SD 7.4). Baseline characteristics were balanced across groups, except the HoLEP patients’ larger PV. IPSS fell from 20.3 (SD 7.1) at baseline to 6.3 (SD 4.2) at 12 months (p < 0.001) without differences between aquablation and HoLEP. HoLEP was associated with shorter operation time (59.5 (SD 18.6) vs. 87.2 (SD 14.8) minutes, p < 0.001) and led to better PV reduction over all timepoints. At three months, aquablation’s results were better regarding ejaculatory (p = 0.02, MSHQ-EjD) and continence function (p < 0.001, ICIQ-SF). Beyond three months, erectile, ejaculatory, continence function and LUTS reduction did not differ significantly between aquablation and HoLEP. CD ≥ grade 3b complications were noted in six patients in aquablation group while only one in HoLEP group (p = < 0.01).ConclusionsWhile aquablation revealed temporary benefits regarding ejaculation and continence at three months, HoLEP was superior concerning operation time, the safety profile and volumetric results.

Differential Effect of 2 Hormonal Contraceptives on the Relative Telomere Length of Youth With Type 1 Diabetes.

Adolescents and young women (AYA) with type 1 diabetes (T1D) may require hormonal contraception for an extended period. However, it is unclear what effect hormonal contraception has on telomere length, a marker of the risk for complications. To investigate the relative telomere length (RTL) in AYA with T1D (AYA-T1D) and healthy young women (AYA-C) after 18 months of combined oral contraception use (COC) with ethinyl estradiol/desogestrel, or a subdermal etonogestrel implant (IM). A nonrandomized prospective study was performed in which 39 AYA-T1D and 40 AYA-C chose the COC or the IM. RTL was measured by monochrome multiplex-quantitative PCR in DNA from peripheral blood mononuclear cells (PBMC). The impact of contraceptives and clinical variables on RTL was assessed using lineal regression analysis. Longer RTL compared to baseline was observed in AYA-T1D (P < .05) and AYA-C (P < .01) after using the IM. However, the total of AYA and the AYA-C group treated with COC decreased RTL after 18 months of treatment compared to baseline (P < .05). The type of contraceptive used was determinant for the changes in RTL compared to baseline in all subjects and controls (P ≤ .006). For AYA-T1D, HbA1c levels were not associated with RTL, but the high-sensitivity C-reactive protein was negatively related with the changes in RTL at 18 months compared to baseline (standardized R2 : 0.230, P = .003). IM was associated with longer RTL in AYA-T1D and AYA-C. In contrast, a shortening of telomere length in PBMC was observed after using COC.

Abstract PO3-03-03: Prospective non-randomized study to compare accuracy of clinical examination under anesthesia, axillary ultrasound and histo-pathological evaluation for axillary nodal staging in women with clinically N0 early breast cancer

Abstract Introduction: Accurate assessment of axillary lymph nodes is crucial in the management of early breast cancer (EBC), especially in clinically node negative (cN0) axilla to avoid extensive axillary surgery. Clinical examination alone underestimates nodal disease in nearly 30% women with cN0 axilla. The current study compares, in cN0 axilla, the benefit of axillary ultrasonography (USG) and clinical axillary examination under anesthesia (EUA) to predict involvement of axillary lymph nodes. The gold standard in these patients however remains pathological evaluation after sentinel node biopsy/low axillary sampling (SNB/LAS) and a complete axillary lymph node dissection (ALND) if node positive. Methodology: Prospectively, 500 women with cN0 EBC were enrolled from Aug 2015 to April 2023 in a study approved by Institutional Ethics Committee. After informed consenting, a preoperative axillary USG was carried out in addition to standard breast imaging to determine number of axillary node(s) and its architecture. The USG assessment was labeled as suspicious or not and the result was blinded to the surgeons. A USG-guided FNAC was not performed as it would then be difficult to blind the surgeon and pathologist preoperatively. During surgery, an initial axillary EUA was performed before starting and any suspicious node was documented. This was followed by axillary staging by standard dual tracer SNB/LAS. A complete axillary dissection was done (level 1-3) if any node was positive on frozen section evaluation or final histopathology. Axillary node histopathology was the gold standard for comparison of effectiveness of clinical exam, USG, EUA, and SNB/LAS for prediction of axilla. Standard diagnostic tests such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were used. Results: Thirty-six patients were excluded in the final analysis (disease progression, chemotherapy first, or had a surgery elsewhere). Of the eligible 464 cN0 patients, 129 were detected to have axillary metastases (27.8%) in final histopathology. The 2 interventions namely USG axilla, EUA were compared to final axillary nodal histopathology. Axillary USG reported suspicious/indeterminate node(s) in 129 (27.8%) patients. USG had a low sensitivity of 46.5% and a low PPV of 46.5% to identify a positive node. However, the specificity and NPV both were 79.4%. Axillary USG was 70.2% accurate in predicting axillary nodal involvement. EUA also had sensitivity of 60% and low PPV of 14.8%. However, the specificity of EUA was 73.4%, NPV of 95.9%; higher than that of USG. EUA was 72.4% accurate. SNB/LAS had the sensitivity of 93.3%, specificity 79.2%, NPV 82.9%, PPV 91.6% and accuracy rate 89.2% in predicting a positive axilla. Conclusions: While the fallacy of clinical exam remains at 27.8%, both USG alone (without FNAC) and EUA failed in predicting a positive axillary node. EUA fared better at predicting a negative axilla. USG guided FNAC would perhaps improve the sensitivity of USG, however additional investigations are difficult in resource constraint and high-volume center, especially, when surgical interventions like SNB or LAS remain standard of care. Table 1 Citation Format: Vani Parmar, Zeal Sanghvi, Shalaka Joshi, Nita Nair, Palak Popat, Seema Kembhavi, Souwmyashree KN, Soujanya Mynalli, Purvi Thakkar, Garvit Chitkara, Sangeeta Desai, Tanuja Shet, Rajendra Badwe. Prospective non-randomized study to compare accuracy of clinical examination under anesthesia, axillary ultrasound and histo-pathological evaluation for axillary nodal staging in women with clinically N0 early breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-03-03.

Comparison of the success rate and marginal bone loss of implants placed simultaneously with either bone expansion or ridge splitting in maxillary sites: a prospective non-randomized study

This study was performed to compare the amount of marginal bone loss (MBL) and the success rate of implants placed following maxillary ridge expansion with two surgical techniques. A non-randomized prospective study was designed. The patients underwent either bone expansion or ridge splitting, and simultaneous implant placement. The implants were loaded according to the delayed loading protocol with single crowns. Each study group included 35 implants placed in 31 patients. One year after loading, the implant success rate was 100 % in both groups. The median MBL was 1.00 mm in both groups (interquartile range 0.10 mm in the bone expansion group and 0.30 mm in the ridge splitting group) (no significant difference, P = 0.749). The median MBL around implants placed in sites with D2, D3, and D4 density bone was 1.40 mm, 1.00 mm, and 0.80 mm in the expansion group and 1.50 mm, 1.00 mm, and 0.85 mm in the splitting group, respectively. There was a significant difference in MBL between the different bone density types within both groups (P < 0.001). In conclusion, no significant difference in the amount of MBL or the success rate was observed between implants placed simultaneously with ridge splitting and those placed simultaneously with bone expansion, in the maxilla.

Comparative study of open onlay mesh repair versus laparoscopic intraperitoneal dual mesh repair for ventral hernia

Background: Ventral abdominal wall hernia surgery is a common procedure in the armamentarium of surgeons. The most common forms of these surgical procedures in adults are the repair of incisional hernias and surgery for paraumbilical hernias. Aims and Objectives: Open onlay mesh repair versus laparoscopic intraperitoneal dual mesh repair (intraperitoneal onlay mesh[IPOM]) for ventral hernia compared to the duration of surgery, post-operative pain, postoperative complications, post-operative hospital stay, return to normal activity, recurrence, and cosmesis. Materials and Methods: The prospective non-randomized study was done in the Maharani Laxmi Bai Medical College, Jhansi, between January 2021 and June 2022 including 100 patients was applied for treatment of ventral hernia repair. Fifty patients were subjected to Group A (open onlay mesh repair) and 50 patients were subjected to Group B (laparoscopic intraperitoneal dual mesh repair). Results: The mean surgery durations were significantly lower in laparoscopic repair when compared to open repair (P&lt;0.001). Themean post-operative stay in the hospital was shorter for the laparoscopic group than for the open hernia group (10.28±2.100 vs. 8.02±1.378 days; P≤0.001). Return to activity or normal daily work is significantly lower in the laparoscopic group as compared to open repair of hernia (5.12±0.659 vs. 2.94±0.550 days; P&lt;0.001). There were fewer post-operative complications with laparoscopy. Conclusion: Laparoscopic intraperitoneal dual mesh repair (IPOM) for ventral hernia in our experience was safe and resulted in fewer complications, shorter hospital stays, and better cosmesis results. Hence, it should be considered the better choice for ventral hernia repair.

Spectrum of poisoning in Bundelkhand region

Background: In Bundelkhand region, 15–18% patients who are attended in the emergency setting comprises poisoning and 60–70% of which are agriculture-based poisons due to its easy accessibility. Aims and Objectives: The aim of this study was to see spectrum of poisoning in Bundelkhand region. Materials and Methods: The prospective non-randomized study was done in Maharani Laxmi Bai Medical College, Jhansi, between December 2020 and October 2022, including 500 patients applied for treatment of different poisoning. Results: In our study, total 500 cases of poisoning were taken. As per found data, majority of patients were found in 17–30 years of age group 202 (40.4%) followed by 31–40 years of age group 157 (31.4%). Minimum 19 (3.8%) cases were found in 61–70 years of age group and 0 case in &gt;70 years of age group. Majority of patients were found male, i.e., 281 (56.2%) and the rest 219 (43.8%) were females. According to finding of our study, maximum mortality rate was found due to Stone hair dye, i.e., 100% followed byCelphos 35.54%, Insecticidal 26.92%, and Alcoholic intoxication 22.22%. As per our study, major cause of taking poison, maximum number of patients were found in marital discord 108 (21.6%) followed by family problems, i.e., 75 (15%), which is similar to separation/death of family member, that is, 74 (14.8%). Conclusion: Concerned authorities should think about substitute of aluminum phosphide, which would be less toxic for human being and concerned authority should ban availability of aluminum phosphide (Celphos) in market.