Prospective Nonrandomized Study Research Articles

Intraoral Scan Accuracy and Time Efficiency in Implant-Supported Fixed Partial Dentures: A Systematic Review.

The digital implant impression technique (DIT) and conventional implant impression technique (CIT) workflows in implant-supported fixed partial dentures (FPDs) have not been extensively compared in prior studies. Moreover, there is no agreement on the more accurate method that entails less time in the laboratory and during the clinical phases of fabrication and delivery of the prosthesis, respectively. This review aimed to assess the precision of the imaging procedure and overall fabrication time of the DIT and CIT for the implant-supported FPDs. An electronic search was performed using PubMed, Scopus, EMBASE, Cochrane Oral Health Group, and Dentistry and Oral Science Source databases through EBSCO for relevant studies from January 2014 to April 2023. Following the preliminary screening, the studies that met the inclusion criteria underwent full-text review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Cochrane Collaboration risk of bias appraisal tool and Newcastle-Ottawa scale were applied to assess the quality of randomized controlled trials (RCTs) and non-randomized prospective clinical studies, respectively. The initial search yielded 332 studies, and after excluding duplicates, 241 papers were available for screening. Titles and abstracts were reviewed, and 97 articles were chosen for full-text review by two authors independently. Furthermore, 89 articles were excluded in compliance with the PICOS question, and eight studies were chosen for qualitative analysis. Hence, the review comprised two RCTs and six prospective clinical studies. The time efficiency of the implant-supported FPDs was examined in four investigations, three of which used the Trios 3 scanner and one used the Intero scanner. The three-dimensional accuracy of DIT and CIT was compared in six clinical comparative studies. One of the RCTs was rated to have a high risk of bias and the other with a moderate quality of evidence. The six prospective studies were rated to have high-quality of evidence. The findings of this review indicate the prospective applicability of future intraoral scanning systems. The DIT was reported to be outstanding in terms of patient preferences and total fabrication time efficiency. Additional in vivo studies are needed to establish the therapeutic usefulness and time efficiency of integrating DIT in more comprehensive settings.

Rheuma-VOR study: optimising healthcare of rheumatic diseases by multiprofessional coordinating centres

ObjectivesEarly diagnosis of inflammatory arthritis is critical to prevent joint damage and functional incapacities. However, the discrepancy between recommendations of early diagnosis and reality is remarkable. The Rheuma-VOR study aimed...

Effect of Lactobacillus kefiri, in Conjunction with PENS T6 and a Hypocaloric Diet, on Weight Loss, Hypertension and Laboratory Glycemic and Lipid Profile.

The pathogenesis of obesity has been linked to alterations in gut microorganisms. The aim of this study was to investigate the effect of Lactobacillus kefiri, together with PENS T6 and a hypocaloric diet, on weight loss, hypertension and laboratory glycemic and lipid profile. A prospective non-randomized study was conducted involving adult patients with a body mass index (BMI) > 30 kg/m2. Patients were divided into two groups: those undergoing PENS-T6 and hypocaloric diet (PENS-Diet Group) and those undergoing the same PENS-T6 scheme and hypocaloric diet, but additionally receiving probiotics including Lactobacillus kefiri (PENS-Diet + L. kefiri Group). Weight loss was assessed at the end of the treatment, and analytical glycemic and lipid profile, and microbiological analysis of feces were performed before and after treatment. The addition of Lactobacillus kefiri to PENS T6 and a low-calorie diet, increases weight loss and further improves the glycemic and lipid profile. L. kefiri also causes a further improvement in obesity-associated dysbiosis, mainly by increasing the muconutritive (Akkermansia muciniphila) and regulatory (Bifidobacterium spp.) microbiome, and the Phylum Bacteroidetes (Prevotella spp.) and decreasing the Firmicutes/Bacteroidetes ratio.

A bispectral index guided comparative evaluation of dexmedetomidine as an adjuvant to propofol-based total intravenous anaesthesia in spine surgeries done under motor-evoked potential monitoring

BackgroundThe anaesthetic agents can affect the quality of motor-evoked potential intraoperatively as they inhibit synaptic transmission. Intravenous anaesthetics suppress motor-evoked potential lesser than inhalational agents, so total intravenous anaesthesia or a combination of intravenous with minimal inhalational anaesthetic supplementation is used when motor-evoked potential is monitored. Motor-evoked potential can get depressed at high doses of propofol required to maintain surgical depth, hence, adjuvant agents like dexmedetomidine that maintain anaesthetic depth without affecting the motor-evoked potential are often required. This study was a prospective non-randomized and comparative study (quasi-experimental) assigned into two groups of 64 each, labelled as the propofol group (group P) and Propofol + dexmedetomidine group (group PD). The primary objective of our study was to compare the total dose reduction of propofol with the addition of dexmedetomidine and their interference with motor-evoked potential readings. The secondary objective was to assess the hemodynamic changes, changes in amplitude and latency of motor-evoked potential, and complications if any.ResultsThe mean total dose of propofol consumed in our study was 502.81 ± 71.01 mg in group propofol( P) and 392.18 ± 59.00 mg in group propofol + dexmedetomidine (PD). Moreover, the mean total dose of propofol (mg) was significantly less used in group PD. Intraoperative hemodynamic stability, no difference in amplitude and latency for motor-evoked potential, and only significant bradycardia in group propofol + dexmedetomidine (PD).ConclusionsDexmedetomidine can be successfully used in propofol-based total intravenous anaesthesia for motor-evoked potential monitoring in spine surgeries, but it is better to maintain stable hemodynamics with a significant reduction of the mean dose of propofol.

Factors Influencing Delay in Diagnosis of Head and Neck Cancer in Rwanda.

Head and neck cancer is a significant contributor to global otolaryngologic disease burden, with a disproportionate impact on low- and middle-income countries. This study investigates the factors contributing to delays in head and neck cancer diagnosis at the University Teaching Hospital of Kigali (CHUK). Cross-sectional study of all patients with a pathologic diagnosis of head and neck cancer presenting to CHUK between January 2021 and June 2022. Sociodemographic data, tumor characteristics, and reasons for delay were collected. Univariate and multivariable analyses were undertaken to evaluate risk factors for delays. Eighty-one patients met criteria for inclusion. Median duration from patient first reported symptoms to initial medical consultation was 52 weeks, from initial medical consultation to referral to CHUK was 4 weeks, and from referral to final pathologic diagnosis was 6 weeks. The most common reason for delay to referral to CHUK was financial (37.04%). Patients who visited traditional healers had higher odds of delay between symptom onset and medical consultation (OR 3.51, CI 1.05-11.70). Delays in final diagnosis after referral were most commonly due to OR availability for biopsy (37.04%) and time for pathology results after biopsy (35.80%). OR availability had a significant impact on duration to final diagnosis (OR 59.48, CI 7.17-493.67). Stage 4 disease had the shortest time to final diagnosis (OR 0.05, CI 0.01-0.45). Understanding the reasons for delayed diagnosis of head and neck cancer may help guide improvements in care, with the goal of reducing global head and neck burden of disease. 3; prospective non-random follow-up study Laryngoscope, 134:1663-1669, 2024.

Treatment of Hidradenitis Suppurativa Evaluation Study(THESEUS): a prospective cohort study.

Hidradenitis suppurativa (HS) is a chronic, painful disease affecting flexures and other skin regions, producing nodules, abscesses and skin tunnels. Laser treatment targeting hair follicles and deroofing of skin tunnels are standard HS interventions in some countries but are rarely offered in the UK. To describe current UK HS management pathways and influencing factors to inform the design of future randomized controlled trials (RCTs). THESEUS was a nonrandomized 12-month prospective cohort study set in 10 UK hospitals offering five interventions: oral doxycycline 200 mg daily; oral clindamycin and rifampicin both 300 mg twice daily for 10 weeks, extended for longer in some cases; laser treatment targeting hair follicles; deroofing; and conventional surgery. The primary outcome was the combination of clinician-assessed eligibility and participant hypothetical willingness to receive each intervention. The secondary outcomes were the proportion of participants selecting each intervention as their final treatment option; the proportion who switch treatments; treatment fidelity; and attrition rates. THESEUS was prospectively registered on the ISRCTN registry: ISRCTN69985145. The recruitment target of 150 participants was met after 18 months, in July 2021, with two pauses due to the COVID-19 pandemic. Baseline demographics reflected the HS secondary care population: average age 36 years, 81% female, 20% non-White, 64% current or ex-smokers, 86% body mass index ≥ 25, 68% with moderate disease, 19% with severe disease and 13% with mild disease. Laser was the intervention with the highest proportion (69%) of participants eligible and willing to receive treatment, then deroofing (58%), conventional surgery (54%), clindamycin and rifampicin (44%), and doxycycline (37%). Laser was ranked first choice by the greatest proportion of participants (41%). Attrition rates were 11% and 17% after 3 and 6 months, respectively. Concordance with doxycycline was 52% after 3 months due to lack of efficacy, participant choice and adverse effects. Delays with procedural interventions were common, with only 43% and 26% of participants starting laser and deroofing, respectively, after 3 months. Uptake of conventional surgery was too small to characterize the intervention. Switching treatment was uncommon and there were no serious adverse events. THESEUS has established laser treatment and deroofing for HS in the UK and demonstrated their popularity with patients and clinicians for future RCTs.

The impact of patient-reported visual disturbance on dynamic visual acuity in myopic patients after corneal refractive surgery.

To investigate the impact of patient-reported visual disturbance on dynamic visual acuity in myopic patients after corneal refractive surgery. This is a prospective nonrandomized study. Adult myopic patients receiving bilateral laser-assisted sub-epithelial keratomileusis (LASEK), femtosecond laser-assisted in situ keratomileusis (FS-LASIK), or small incision lenticule extraction (SMILE) with Plano target were included. Eight types of patient-reported visual disturbance were evaluated regarding frequency, severity and bothersome and dynamic visual acuity (DVA) of 40 and 80 degrees per second (dps) was measured postoperatively at 3 months. The study enrolled 95 patients with an average age of 27.6 ± 6.4 years. The most frequently reported visual disturbance was the fluctuation in vision (70.5%), followed by glare (66.3%) and halo (57.4%). Postoperative DVA at 80 dps was significantly associated with the total score of haloes (p = 0.038) and difficulty in judging distance (p = 0.046). Significant worse postoperative DVA at 40 dps was observed in patients with haloes than those without (p = 0.024). The DVA at 80 dps for patients without haloes or difficulty in judging distance was significantly better than that with the symptoms (haloes, p = 0.047; difficulty in judging distance, p = 0.029). Subgroup analysis by surgical procedures demonstrated that the significant difference in DVA between patients with and without visual disturbance was only observed in patients receiving FS-LASIK. Postoperatively, myopic patients undergoing corneal refractive surgery with haloes or difficulty in judging distance have significantly worse low and high-speed DVA than those without the symptoms. The present study provided the basis for postoperative guidance in daily tasks involving dynamic vision when patients have visual disturbances.

FRI072 Biomechanical CT To Assess Bone After Sleeve Gastrectomy In Adolescents With Obesity- Prospective Longitudinal Study

Abstract Disclosure: V. Singhal: None. F.A. Huber: None. S. Tuli: None. M. Bouxsein: None. M. Misra: None. M.A. Bredella: None. Background and Objective: Sleeve gastrectomy (SG) is effective in treating cardiometabolic complications of obesity but is associated with bone loss. Our aim was to determine the effect of SG on the lumbar spine by biomechanical computed tomography (CT) analysis in adolescents/young adults with obesity. We hypothesized that SG would lead to a decrease in strength and BMD compared to non-surgical controls. Methods: 12-month prospective non-randomized study of adolescents/young adults with obesity who either underwent SG (N=29) or were followed without surgery (controls, N=30). At baseline and 12 months, participants underwent QCT of L1 and L2 for biomechanical assessment and MRI of the abdomen and mid-thigh for body composition assessment. 12-month changes between groups were compared using Student’s t-test, and changes within groups were assessed using paired t-tests. Analyses were controlled for baseline and 12-month changes in BMI by multivariable analyses. Regression analysis was performed to evaluate the effect of body composition on bone parameters. Results: Participants in the SG group had a higher baseline BMI than controls (p=0.01) and lost an average of 34.3±13.6 kg 12 months after surgery, whereas weight was unchanged in controls (p<0.001). There were significant reductions in abdominal adipose tissue and thigh muscle area in the SG group compared to controls (p<0.001). Significant decreases in bone strength [-609 (-928, -291) vs. 103 (-173, 380) N], bending stiffness (-0.08 ± 0.16 vs. 0.07 ± 0.15 kNm/rad), average vBMD (-12 ± 12 vs. 0 ± 13 mg/cm3) and trabecular vBMD (-15 ± 13 vs. 2 ± 13 mg/cm³) were noted in the SG vs. control groups (all p<0.001). After controlling for change in BMI, a 12-month reduction in cortical BMD was significant in the SG group compared to controls (p=0.02). Reductions in strength and trabecular BMD were associated with reductions in BMI, visceral adipose tissue, and muscle (p≤0.03). Conclusion: Adolescents undergoing SG had a decrease in strength and volumetric BMD of the lumbar spine compared to non-surgical controls; reductions in cortical BMD were independent of weight reductions over the study duration. These changes were associated with a decrease in visceral fat and muscle mass. Presentation: Friday, June 16, 2023

Botulinum Toxin for the Management of Pelvic Floor Tension Myalgia and Persistent Pelvic Pain: A Systematic Review and Meta-analysis.

To systematically review the literature on use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain. The ClinicalTrials.gov, PubMed, EMBASE, and Scopus databases were searched from inception to November 2022 by two independent assessors (B.L.K. and F.G.L.). Identified studies were screened by title and abstract and included after full-text review. Data extraction was subsequently performed and recorded in Microsoft Excel. This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines after registration in PROSPERO (CRD42022289132). All randomized studies, prospective studies with more than five participants, and retrospective studies with more than 10 participants published in English or French and assessing the use of botulinum toxin for the treatment of pelvic floor tension myalgia and persistent pelvic pain in women were included. Meta-analyses were performed on randomized data. Of 4,722 articles identified, 24 satisfied inclusion criteria. A meta-analysis of five randomized controlled trials totaling 329 participants demonstrated no differences in patient- and clinician-reported outcome measures, including pain, dyspareunia, sexual function, and vaginal manometry. Mean duration of follow-up was 6 months. A qualitative analysis of 14 prospective and four retrospective studies including 804 participants is supportive of botulinum toxin; however, the quality of data is low, and there is marked heterogeneity between studies. Meta-analyses of randomized data do not support the use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain. Failure of these data to confirm the findings of nonrandomized prospective studies that suggest a treatment benefit may be attributable to the absence of placebo control and confounding outcomes obtained from an active comparator group. Further randomized controlled trials with true placebo are strongly recommended. PROSPERO, CRD42022289132.

Computed Tomography versus Sleep Endoscopy (DISE) to Predict the Effectiveness of Mandibular Advancement Devices in Adult Patients with Obstructive Sleep Apnea: A Protocol for Systematic Review.

Obstructive sleep apnea is a sleep disorder with a high prevalence in the world population. The mandibular advancement device is one of the options for treating obstructive sleep apnea. Neck computed tomography and drug-induced sleep endoscopy are complementary diagnostic tests that may help predict the effectiveness of mandibular advancement devices. This study aims to analyze the best method for predicting the effectiveness of mandibular advancement devices in the therapeutic approach to obstructive sleep apnea. PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science Core Collection databases will be comprehensively searched. We will include randomized clinical trials, non-randomized prospective or retrospective clinical studies, case controls, cohort studies, and case series. Two authors will independently conduct data extraction and assess the literature quality of the studies. The analysis of the included literature will be conducted by Revman 5.3 software. The outcomes that will be analyzed are craniofacial characteristics, cephalometric assessments, site and type of obstruction of the upper airway, mean values of the apnea-hypopnea index, and SaO2 verified in the initial and follow-up polysomnography. This study will provide reliable, evidence-based support for the clinical application of mandibular advancement devices for obstructive sleep apnea.

A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer.

Published data supports the use of very high dose intensity modulated radiotherapy (IMRT) in achieving high efficacy and low toxicity for high-risk prostate cancer (HRPCa). This phase II multi-institutional non-randomized prospective dose escalation study using intensity modulated radiotherapy (IMRT) for high risk N0M0 prostate cancer was designed to investigate dose escalation using 1.8 Gy increments from baseline 75.6 Gy up to maximum 81 Gy, once dose volume constraints were adhered to. Inclusion criteria were patients undergoing a radical course of RT for high and very high-risk disease, defined as one or more of the criteria ≥ T3*, ≥ Gleason 8, Prostate specific antigen (PSA) > 20ng/ml. All patients received Androgen Deprivation Therapy (ADT) and none had radiological evidence of distant metastatic disease. The primary objective was to determine if dose escalated IMRT for high risk localized prostate cancer could provide freedom from biochemical relapse (BR; PSA rising > nadir +2ng/mL or initiation of salvage hormone therapy) similar to that reported in the literature. The Kaplan-Meier method was used to estimate survival times. Secondary objectives included OS, Disease Free Survival (DFS), and the incidence and severity of Genito-urinary (GU), Gastro-intestinal (GI) and erectile dysfunction (ED) toxicities (CTCAE v.3). Toxicities and performance status were collected and graded weekly during RT, 2 months after completing RT, 8 months' post RT, and 6 monthly thereafter to year five and annually thereafter to year nine. A total of 230 evaluable patients were enrolled between April 2009 and June 2016. The median follow-up was 7.3 years. The cumulative proportion of patients surviving without BR at 5 years was 91% (95% Confidence Interval (CI): 86% to 94%). Overall survival at 5 and 7 years was 92% (88% to 95%) and 89% (83% to 92%) respectively, while the cumulative proportion of patients free from disease was 89% (84% to 93%) at 5 years and 81% (75% to 86%) at 7 years. The incidence of acute G2 and G3 toxicities were; GU; 57.8% G2, 12.6% G3, GI; 15.2% G2, 0.4% G3, ED; 30.0% G2 and 61.7% G3. The incidence of late G2, G3 and G4 toxicities were; GU; 40.9% G2, 8.7% G3, GI; 36.5% G2, 2.2% G3, 0.4% G4, ED; 11.7% G2 and 86.1% G3. The percentage of patients receiving each dose level was; 3.5% received 75.6Gy in 42 fractions, 2.2% received 77.4Gy in 43 fractions, 93% received 81Gy in 45 fractions. The findings indicate that high-dose IMRT is well tolerated and is associated with excellent long-term tumor-control outcomes in patients with localized high and very high-risk prostate cancer, with 91% of patients surviving at 5 years without biochemical relapse. The rates of long term G3 GU and GI toxicity were low at 8.7% and 0.4% respectively.

Dynamics of the ultrasonographic picture of the skin and subcutaneous tissue in the physiotherapy treatment of cellulite by compression microvibration: а non-randomized prospective study

BACKGROUND: Various methods are offered to effectively eliminate cellulite and improve skin appearance; however, its treatment remains one of the most difficult tasks in aesthetic medicine. The arsenal of tools that allow an objective assessment of cosmetic and esthetic therapeutic measures is very limited.
 AIM: To evaluate the effectiveness of the compression microvibration method to treat structural and functional skin changes in women with gynoid lipodystrophy of different age groups.
 MATERIALS AND METHODS: A single-center, nonrandomized, prospective study of the effectiveness of the compression microvibration method (Endospheres Therapy) was carried out in 27 women (4069 years old) with mild-to-moderate gynoid lipodystrophy under the control of ultrasonographic skin examination before treatment, after 12 procedures, and after 2 months. After a course of therapy, skin ultrasonography was performed using a specialized high-resolution digital ultrasound system DUB SkinScanner (tpm GmbH, Germany) equipped with a 75 MHz transducer with a resolution of 21 m and a scanning depth of 46 mm. Additionally, anthropometric parameters were measured, and the body mass index was calculated.
 RESULTS: Changes in body mass index (BMI) revealed a trend toward weight loss in most of the participants. The circumference of the hips and waist in participants aged 4049, 5059 and 6069 years decreased by 3.01.1 and 5.31.1, 2.20.9 and 4.11.3 and 2.50.9 and 6.31.5 cm, respectively. It was found that after the course of Endospheres Therapy in patients of the 1st, 2nd and 3rd age groups in the areas of the anterior, inner, posterior surface of the thigh and the anterior surface of the abdomen, the thickness of the dermis decreased by 15.6, 9.5 and 18.1%; 10.9, 10.5 and 19.3%; 6.1, 15.7 and 13.8%, 23.4, 14.7 and 14.5% (p 0.05), respectively; increased echogenicity of the dermis in the areas of the anterior, inner, posterior thigh and anterior abdominal surface by 2, 1.4 and 1.3; 1.2, 1.4 and 1.2; 1.4, 1.4 and 1.5; 1.3, 1.5 and 1.7 times (p 0.05), respectively. The echogenicity of the hypodermis decreased in the studied areas by 30.8, 27.6 and 31.2% (p 0.05); 20.1, 37.3 and 40.4% (p 0.05); 43.2, 57.8 (p 0.05) and 9.3%; 23.6, 15.2 (p 0.05) and 9.3%, respectively. The effect persisted 60 days after the course of therapy.
 CONCLUSION: These results have convincingly demonstrated the effectiveness of Endospheres Therapy in women with mild-to-moderate gynoid lipodystrophy for body shaping and skin improvement in the long term without revealing any side effects.

Combined endoscopic and laparoscopic surgery (CELS) for early colon cancer in high-risk patients

BackgroundLocal excision of early colon cancers could be an option in selected patients with high risk of complications and no sign of lymph node metastasis (LNM). The primary aim was to assess feasibility in high-risk patients with early colon cancer treated with Combined Endoscopic and Laparoscopic Surgery (CELS).MethodsA non-randomized prospective feasibility study including 25 patients with Performance Status score ≥ 1 and/or American Society of Anesthesiologists score ≥ 3, and clinical Union of International Cancer Control stage-1 colon cancer suitable for CELS resection. The primary outcome was failure of CELS resection, defined as either: Incomplete resection (R1/R2), local recurrence within 3 months, complication related to CELS within 30 days (Clavien–Dindo grade ≥ 3), death within 30 days or death within 90 days due to complications to surgery.ResultsFifteen patients with clinical T1 (cT1) and ten with clinical T2 (cT2) colon cancer and without suspicion of metastases were included. Failure occurred in two patients due to incomplete resections. Histopathological examination classified seven patients as having pT1, nine as pT2, six as pT3 adenocarcinomas, and three as non-invasive tumors. In three patients, the surgical strategy was changed intraoperatively to conventional colectomy due to tumor location or size. Median length of stay was 1 day. Seven patients had completion colectomy performed due to histological high-risk factors. None had LNM.ConclusionsIn selected patients, CELS resection was feasible, and could spare some patients large bowel resection.

The added value of devices to pelvic floor muscle training in radical post-prostatectomy stress urinary incontinence: A systematic review with metanalysis.

To investigate the role of pelvic floor devices (e.g., biofeedback, electrical stimulation, magnetic stimulation, or their combination) as adjunctive treatments in pelvic floor muscle training (PFMT) in stress urinary incontinence (SUI) after radical prostatectomy. A systematic review with meta-analysis. We searched for randomised controlled trials (RCTs) and prospective non-randomised studies investigating the effectiveness of pelvic floor devices as an adjunctive treatment for SUI symptoms assessed with weight pad-test or standardised questionnaires. To assess the risk of bias (RoB) and overall certainty of evidence, the RoB 2.0 or the ROBINS-I, and the GRADE approach were used. Eleven RCTs met our eligibility criteria. One was at a 'low' RoB, one had 'some concerns', while nine were at a 'high' RoB. Two meta-analyses were conducted to analyse the pooled results of six RCTs included. Specifically, two RCTs reported at week 4 with a 1h pad test a mean difference of 0.64 (95% CI = [-13.09, 14.36]), and four RCTs reported at week 12 with a 24h pad test a mean difference of -47.75 (95% CI = [-104.18, 8.69]). The heterogeneity was high in both analyses (I2 = 80.0%; I2 = 80.6%). The overall level of certainty was very low. In line with our results, we cannot conclude whether pelvic floor devices add any value as adjunctive treatment in the management of SUI after radical prostatectomy. Future studies require more comprehensive and standardised approaches to understand whether these devices are effective.

The Role of Hepatobiliary Scintigraphy as the Initial Investigative Modality for Significant Bile Leak following Laparoscopic Cholecystectomy

Introduction: Currently, the rate of bile duct injury and leak following laparoscopic cholecystectomy (LC) is still higher than for open surgery. Diverse investigative algorithms were suggested for bile leak, shifting from hepatobiliary scintigraphy (HBS) toward invasive and more sophisticated means. We aimed to analyze the use of biliary scan as the initial modality to investigate significant bile leak in the drain following LC, attempting to avoid potential unnecessary invasive means when the scan demonstrate fair passage of nuclear substance to the intestine, without leak. Methods: We have conducted a prospective non-randomized study, mandating hepatobiliary scintigraphy first, for asymptomatic patients harboring drain in the gallbladder fossa, leaking more than 50 mL/day following LC. Analysis was done based on medical data from the surgical, gastroenterology, and the nuclear medicine departments. Results: Among 3,124 patients undergoing LC, significant bile leak in the drain was seen in 67 subjects, of whom we started with HBS in 50 patients, presenting our study group. In 27 of whom, biliary scan was the only investigative modality, showing fair passage of the nuclear isotope to the duodenum and absence of leak in the majority. The leak stopped spontaneously within a mean of 3.6 days, and convalescence as well as outpatient clinic follow-up was uneventful. In 23 patients, biliary scan that was interpreted as abnormal was followed by endoscopic retrograde cholangio-pancreatography (ERCP). However, ERCP did not demonstrate any bile leak in 13 subjects. In 17 patients, ERCP was used initially, without biliary scan, suggesting the possibility of avoiding invasive modalities in 7 patients. Conclusions: Based on a negative predictive value of 91%, we suggest that in cases of asymptomatic significant bile leak through a drain following LC, a normal HBS as the initial modality can safely decrease the rate of using invasive modalities.

Early Postoperative Changes in Macular Choroidal Thickness After Uncomplicated Phacoemulsification in Patients With and Without Glaucoma: A Swept-Source Optical Coherence Tomography Study.

Purpose The objective of this study was to examine the impact of uncomplicated phacoemulsification on macular choroidal thickness (CT) within the first three postoperative months and to investigate its relationship with postoperative cystoid macular edema (CME) in both glaucomatous and healthy subjects, utilizing swept-source optical coherence tomography (SS-OCT). Methods The non-randomized prospective study involved 82 patients, selected via convenience sampling from the First Department of Ophthalmology, Medical School of Athens, "G. Gennimatas" Hospital, Athens, Greece, between May 2018 and May 2022, undergoing phacoemulsification and intraocular lens (IOL) implantation. The inclusion criteria encompassed patients aged 50 years or above, with or without glaucoma. Patients with ocular pathologies that could influence macula or CT measurements were excluded. Data collection focused on retinal and CT variablesof the macular area, measured using SS-OCT. Baseline measurements were established preoperatively, with follow-up assessments at one week, one month, and three months postoperatively to monitor CT and macular edema onset. Results A total of 82 eyes from 82 patients with a mean age of 79.1±8.3 years were included. The study population was divided into a glaucoma group (n=28 eyes) and a control group (n=54 eyes). Our findings indicate a consistently significant increase in macular CT measurements one month after cataract surgery, observed in both glaucomatous and non-glaucomatous eyes. In the first postoperative week, statistically significant changes in CT were observed only in patients with CME. Subsequently, at one-month interval, both patient groups, those with and without CME, exhibited statistically significant changes in CT across all macular sectors. CME was detected in 10 out of 28 eyes in the glaucoma group and in 16 out of 54 eyes in the control group. When evaluating the impact of postoperative CME on groups of glaucomatous and non-glaucomatous eyes, it was observed that glaucomatous eyes exhibited a significantly larger magnitude of change in subfoveal CT (SFCT) (p=0.03) at one month (relative to baseline) compared to non-glaucomatous eyes. There was also a 31% increase in the odds of developing CME for glaucoma patients; this result was not statistically significant (odds ratio {OR}, 1.31; 95% confidence interval {CI}, 0.50-3.47; p=0.57). Conclusions During the early postoperative period, the study revealed a significant increase in CT at one month after phacoemulsification in both glaucomatous and non-glaucomatous eyes. When CME was present, a significantly more pronounced magnitude of change in SFCT was observed at one month in glaucomatous eyes, as opposed to non-glaucomatous eyes. This observation suggests a possible selective susceptibility of glaucomatous eyes in the early postoperative period that requires further research.

Comparison of the efficacy of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy.

Intravenous glucocorticoids (GCs) are the mainstay of treatment for severe forms of Graves' orbitopathy (GO). Our aim was to assess the effectiveness and safety of a modified monthly regimen (mMR) and to compare them with those of the established weekly regimen (WR). This was a prospective non-randomized single-center study involving 62 patients, divided into two therapeutic groups depending on their referral time. Thirty-one subjects, admitted in the period 2017-2018, were treated with mMR, total dose-5.5g, with intake of oral GCs after completion of intravenous infusions. Thirty subjects, who were referred in the period 2019-2020, were treated with WR, total dose-4.5g One patient refused to be part of the WR group and was treated with mMR. Eye status and therapeutic response were evaluated on the 1st, 3rd and 6th months, quality of life-at 3rd and 6th month. At 1st month and 3rd month, there was no significant difference in the therapeutic response between the two groups. At 3rd month, the proportion of patients with improvement in soft tissue manifestations and subjective complaints was significantly higher in mMR group (65.6% vs. 40% and 81.3% vs. 46.7%, respectively) and the same manifestations were of significantly milder degree. At 3rd month, significant improvement in quality of life was found without significant difference between the two groups. At 6th month, worsening of GO occurred in 3 patients from WR group, while in 5 patients from mMR group further improvement was found. The two GC regimens have comparable efficacy with small differences in the time of onset of the effect and its duration, as well as in the effectiveness on some ocular manifestations. Trial registration number NCT05793359/29.03.2023, retrospectively registered..

D-line Approach for Safe Laparoscopic Cholecystectomy: Initial Experience.

Introduction The critical view of safety is an important concept for safe laparoscopic cholecystectomy. However, no standard step-by-step approach for achieving the critical view of safety has been established until now. Therefore, this study aims to evaluate a new approach for achieving the critical view of safety using the diagonal line of liver segment IV as an anatomical landmark. Patients and methods In this prospective non-randomized study, patients (n= 112) who underwent laparoscopic cholecystectomy for symptomatic cholelithiasis were included. The first 47 patients underwent laparoscopic cholecystectomy using the diagonal line approach (DLC group) whereas, the next 65 patients underwent laparoscopic cholecystectomy using the conventional method (CLC group). Results No significant difference between both groups regarding the preoperative characteristics, operative time, and intraoperative blood loss. Laparoscopic subtotal cholecystectomy was performed more in the DLC group (6% vs 0%, p= 0.07). Whereas, in the CLC group, there was a tendency towards conversion to open cholecystectomy in difficult cases (6% vs 2%, p= 0.40). No intra- or postoperative complications occurred in either group. Conclusion The diagonal line approach is a feasible and useful step-by-step technique to achieve the critical view of safety in laparoscopic cholecystectomy and enables surgeons to perform safe laparoscopic subtotal cholecystectomy in difficult cases.

A wearable chatbot-based model for monitoring colorectal cancer patients in the active phase of treatment

Colorectal cancer is one of the leading causes of death in the world. This study presents the findings of a prospective non-randomized clinical study for evaluating a new computational model for monitoring colorectal cancer patients in the active treatment phase using artificial intelligence and the Internet of Things. For eight weeks, patients self-reported perceived symptoms and adverse effects, practiced physical activity, and data about their diet. The outcome assessment was based on comparing the intervention and control groups. Patients evaluated the model using the User Experience Questionnaire (UEQ) and the System Usability Scale (SUS). Patients who participated in the model reported signs and symptoms more accurately (control: 64.7%; intervention: 92.3%; p = 0.1038). In the intervention group, physical activity was more effective, and most patients (61.5%) interacted with the chatbot for at least 62.5% of the period. Results indicate that the model contributes to more assertive data collection and greater patient engagement in self-management of symptoms and adverse effects of treatment and cancer. Moreover, the model contributed to increasing the practice of light physical activity by patients. UEQ and SUS scores indicate that the model met users’ expectations and has acceptable usability.

Neutrophil extracellular traps-associated markers in malignant neoplasms of the female reproductive system after surgical treatment and adjuvant chemotherapy

Introduction. Studies evidence about a relation between increased circulating free DNA (cfDNA) concentrations and chemotherapy, the majority of which have been focused on considering a tumor as a source of cfDNA. It has been suggested that neutrophils also contribute to this process, as cancer-related cfDNA characteristics resemble those of neutrophil extracellular traps (NETs). Therefore, the elevated concentration of cfDNA observed in chemotherapy patients may be associated with NETosis.Aim: assessment of NETosis markers in surgical treatment and adjuvant chemotherapy of patients with malignant neoplasms of the female reproductive system.Materials and Methods. A prospective non-randomized interventional controlled study was carried out by enrolling 111 patients with malignant breast diseases and female genital organs of various localizations and stages hospitalized for elective surgical treatment or chemotherapy course. The control group included 33 healthy women. 69 patients underwent surgical treatment. Adjuvant chemotherapy with paclitaxel and carboplatin was performed in 25 patients with ovarian cancer and 17 patients with breast cancer. In cancer patients, citrullinated histone H3 (citH3) and myeloperoxidase (MPO) were chosen as NETosis biomarkers allowing to distinguish NETs from other tumor-derived cfDNA thereby improving quality of research study. The concentration of NETosis markers was assessed before surgery or onset of chemotherapy upon admission to hospital and 14 days after surgery or 14 days after the second course of chemotherapy.Results. In all patients, the concentrations of NETosis markers before the start of therapy were significantly increased compared to the control group as well as 14 days after surgical treatment and 14 days after the second course of chemotherapy. However, in surgical patients, no significantly increased concentration of NETosis markers postvs. pre-surgery magnitude was observed. Upon that, patients underwent 2 courses of chemotherapy vs. baseline level were found to have significantly elevated magnitude of NETosis markers.Conclusion. The study revealed the relationship between administration of paclitaxel-containing chemotherapy in patients with ovarian cancer and breast cancer and a rise in NETs level. Chemotherapy is an essential component for management of patients with malignant neoplasms of the female reproductive system, therefore, development of new strategies to lower a risk of thrombosis and resistance to it is of crucial importance.