3-year real-world outcomes with the Swedish adjustable gastric band™ in France.
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ABSTRACT:
SUBMITTER: Ribaric G
PROVIDER: S-EPMC3560940 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PurposeStapled transanal rectal resection (STARR) in patients with obstructive defecation syndrome (ODS) is limited by the capacity of the circular stapler used. This prospective cohort study was conducted to assess real-world clinical outcomes of STARR with the new CONTOUR® TRANSTAR™ device, shortly named TRANSTAR, at 12 months postoperatively.MethodsFrom January 2009 to January 2011, consecutive patients who underwent TRANSTAR in 22 European colorectal centers were enrolled in the study. Functional outcomes and quality of life were assessed by the changes in a number of scoring systems (Knowles-Eccersley-Scott-Symptom (KESS) score, ODS score, St. Mark's score, Euro Quality of Life-5 Dimension (EQ-5D) score, and Patient Assessment of Constipation-Quality of Life (PAC-QoL) score), at 12 months as compared to baseline. All complications were recorded and analyzed.ResultsA total of 100 patients (98% female), mean age 60 years, were entered in the study. Statistically significant improvements were seen in the KESS (median 18 vs. 6; p < 0.01), ODS (median 15 vs. 4; p < 0.01), and PAC-Qol scores (median 2.10 vs. 0.86; p < 0.01). St. Mark's and EQ-5D scores improved nonsignificantly. Complications were reported in 11 % of patients, including bleeding (5%), staple line complications (3%), urinary retention (2%), and persistent pain (1%). No major complications or mortality occurred.ConclusionTRANSTAR facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively. It represents a safe and effective treatment for ODS in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.
| S-EPMC3996277 | biostudies-literature
Project description:We describe a case of polymicrobial bacterial pericarditis with Klebsiella pneumoniae and Proteus mirabilis, caused by pericardial penetration of the tip of the catheter of a laparoscopic adjustable gastric band (LAGB). The patient developed a cardiac tamponade, and subsequently emergency pericardiocentesis was performed. Analysis of earlier CT scans showed that the tip of the catheter had migrated through the liver and through the diaphragm into the pericardium, and was in contact with the myocardium. After stabilisation he was operated to remove the LAGB. In this case report, we describe the chain of events that led to the polymicrobial pericarditis-a complication of LAGB placement that to our knowledge has thus far never been reported. We furthermore present a detailed literature review of all published cases of polymicrobial pericarditis and its causes.
| S-EPMC5836605 | biostudies-literature
Project description:Laparoscopic adjustable gastric banding (LAGB) is the third most popular bariatric procedure. Despite its reversibility and minimal invasiveness, band infection affects 1.2% of patients. We present a case of a 25-year-old, obese woman who was experiencing malaise and feverishness 3 years after gastric band placement. Due to port site infection the port was removed, which did not improve the patient's condition. After 2 years the band was removed via laparotomy with a minor surgical site infection reported. The patient returned 2 weeks after discharge with signs of sepsis. After ruling out pulmonary causes, an exploratory laparotomy was performed, revealing granulomatous peritonitis. Standard histopathological examinations, broncho-alveolar lavage culture and DNA tests along with microbiological cultures were inconclusive. Broad-spectrum antibiotics and antifungal and antiparasitic agents did not improve the patient's condition. Mycobacterium tuberculosis DNA was discovered in a greater omentum specimen. The patient was treated with isoniazid, rifampicin, pyrazinamide and streptomycin for four months.
| S-EPMC5502335 | biostudies-other
Project description:BackgroundLevodopa-carbidopa intestinal gel (LCIG) is an established treatment for improving motor and some non-motor symptoms (NMS) in patients with advanced Parkinson's disease (PD). Prospective long-term data in routine clinical practice are limited.ObjectiveAssess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-world routine clinical practice.MethodsDuodopa/Duopa in patients with advanced Parkinson's disease-a global observational study evaluating long-term effectiveness (DUOGLOBE) (NCT02611713) is an ongoing, prospective, multinational, observational study of LCIG-naïve patients treated as part of routine clinical practice; 3 years of follow-up are planned. The primary outcome is the change in patient-reported off time. Other assessments include the Unified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Sleep scale (PDSS-2), Epworth Sleepiness Scale (ESS), health-related quality of life (HR-QoL), caregiver burden, and serious adverse events (SAEs). Outcomes from baseline to month (M) 12 are presented.ResultsIn this 12-month follow-up, patients (N = 195) had baseline characteristics similar to other LCIG studies. Significant improvements (mean change to M12) were observed in off time (-3.9 ± 3.6 hr/day, P < 0.001), dyskinesia assessed using the UDysRS (-9.6 ± 22.5, P < 0.001), NMSS (-23.1 ± 41.4, P < 0.001), sleep and sleepiness symptoms on the PDSS-2 (-6.5 ± 12.2, P < 0.001) and ESS (-1.0 ± 5.7, P < 0.05), HR-QoL (-9.0 ± 21.6, P < 0.001), and caregiver burden (-1.9 ± 6.7, P = 0.008). Overall, 40.5% (n = 79) of patients experienced SAEs; fall (n = 6; 3.1%) and urinary tract infection (n = 6; 3.1%) were SAEs reported in ≥3% of patients.ConclusionsThese 12-month outcome data show sustained, long-term improvements and support the real-world effectiveness of LCIG in patients with advanced PD. Safety was consistent with previous studies.
| S-EPMC8485588 | biostudies-literature
Project description: Not available
| S-EPMC8139945 | biostudies-literature
Project description:AIM:To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwanese patients with polypoidal choroidal vasculopathy (PCV) by performing a retrospective exploratory subgroup analysis of the REAL study. METHODS:REAL was a 12-month, observational, prospective, non-interventional phase IV post-marketing surveillance study conducted at 9 centers in Taiwan. The study collected data as part of the routine patient visits from the medical records of patients with neovascular age-related macular degeneration treated with ranibizumab 0.5 mg according to local standard medical practice and local label and/or reimbursement guidelines. The presence of PCV at baseline was determined using indocyanine green angiography. RESULTS:At baseline, PCV was diagnosed in 64 of the 303 enrolled patients (21.1%). Of these, 41 patients (64.1%) had received prior treatment; 15 (23.4%) patients had received ranibizumab. The intent-to-treat population included 58 patients; 47 (80%) who received ranibizumab and 11 (20%) who received ranibizumab plus photodynamic therapy (PDT; 9 patients received once, 2 patients received twice). Bevacizumab was used as a concomitant medication in a similar percentage of patients who received ranibizumab (43%, n=20) or ranibizumab plus PDT (45%, n=5). In patients who received ranibizumab, visual acuity (VA) at baseline was 50.1±12.9 Early Treatment Diabetic Retinopathy Study letters, and the gain at month 12 was 1.1±17.8 letters. In patients who received ranibizumab plus PDT, VA at baseline was 51.4±15.9 letters, and there was a marked gain in VA at month 12 (14.0±9.2 letters, P=0.0009). In the intent-to-treat population, the reduction in central retinal subfield thickness from baseline at month 12 was 69.6±122.6 µm (baseline: 310.8±109.8 µm, P=0.0004). The safety results were consistent with the well-characterized safety profile of ranibizumab. CONCLUSION:In real-world settings, ranibizumab 0.5 mg treatment for 12mo results in maintenance of VA and reduction in central retinal subfield thickness in Taiwanese patients with PCV. Improvements in VA are observed in patients who received ranibizumab plus PDT. There are no new safety findings.
| S-EPMC6232327 | biostudies-other
Project description:ContextIt is not known whether the magnitude of metabolic adaptation, a greater than expected drop in energy expenditure, depends on the type of bariatric surgery and is associated with cardiometabolic improvements.ObjectiveTo compare changes in energy expenditure (metabolic chamber) and circulating cardiometabolic markers 8 weeks and 1 year after Roux-en-y bypass (RYGB), sleeve gastrectomy (SG), laparoscopic adjustable gastric band (LAGB), or a low-calorie diet (LCD). Design, Setting, Participants, and Intervention: This was a parallel-arm, prospective observational study of 30 individuals (27 females; mean age, 46 ± 2 years; body mass index, 47.2 ± 1.5 kg/m2) either self-selecting bariatric surgery (five RYGB, nine SG, seven LAGB) or on a LCD (n = 9) intervention (800 kcal/d for 8 weeks, followed by weight maintenance).ResultsAfter 1 year, the RYGB and SG groups had similar degrees of body weight loss (33-36%), whereas the LAGB and LCD groups had 16 and 4% weight loss, respectively. After adjusting for changes in body composition, 24-hour energy expenditure was significantly decreased in all treatment groups at 8 weeks (-254 to -82 kcal/d), a drop that only persisted in RYGB (-124 ± 42 kcal/d; P = .002) and SG (-155 ± 118 kcal/d; P = .02) groups at 1 year. The degree of metabolic adaptation (24-hour and sleeping energy expenditure) was not significantly different between the treatment groups at either time-point. Plasma high-density lipoprotein and total and high molecular weight adiponectin were increased, and triglycerides and high-sensitivity C-reactive protein levels were reduced 1 year after RYGB or SG.ConclusionsMetabolic adaptation of approximately 150 kcal/d occurs after RYGB and SG surgery. Future studies are required to examine whether these effects remain beyond 1 year.
| S-EPMC6459006 | biostudies-literature
Project description:Elevated rates of psychopathology are noted among severely obese youth presenting for weight loss surgery. The role of mental health providers in this population is not well defined, and the selection of candidates is often the result of clinical judgment alone. The purpose of this study was to comprehensively evaluate psychiatric symptoms among a large sample of adolescents receiving laparoscopic adjustable gastric banding (LAGB) by (1) examining changes in depressive symptoms and quality of life in the year following surgery; (2) evaluating the interaction between patterns of change in depression, quality of life, and weight postsurgery; and (3) identifying presurgical psychological predictors of initial weight change.Participants were 101 severely obese adolescents aged 14 to 18 years receiving LAGB at the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children's Hospital of New York Presbyterian/Columbia University Medical Center between August 2006 and December 2009. Measures of height, weight, depressive symptoms, and quality of life were obtained in the first year following surgery. Changes in the Beck Depression Inventory (BDI), Pediatric Quality of Life Inventory (PedsQL), and body mass index were analyzed using latent growth curve modeling.Short-term changes in psychiatric symptoms and weight were analyzed using latent growth curve modeling. Significant changes in total BDI (?slope = -0.885, SE = 0.279, P < .01; ?quadratic = 0.054, SE = 0.021, P < .001) and PedsQL (?slope = -0.885, SE = 0.279, P < .001) scores were observed following LAGB, and comparable postoperative changes between psychosocial variables and body mass index were also noted (BDI: covariance [COV] = 0.21, SE = 0.06, P < .001; PedsQL: COV = -0.41, SE = 0.10, P < .01). Two variables (family conflict/loss of control eating) were found to be significant predictors of weight change over the year following surgery (P < .05).Adolescents experienced notable improvements in initial depressive symptoms and quality of life after LAGB, and measures of preoperative binge eating and family conflict affected postsurgery body mass index among youth.ClinicalTrials.gov identifier: NCT01045499.
| S-EPMC3640529 | biostudies-literature
Project description:With increasing number of therapies available for the treatment of multiple myeloma, it is timely to examine the course of patients' journeys. We investigated patient characteristics, treatment durations and outcomes, and symptom burden across the treatment pathway in Belgium, France, Germany, Italy, Spain, Switzerland and the UK. In total, 435 physicians retrospectively reviewed 4997 patient charts. Profiles of patients diagnosed with multiple myeloma during the last 12 months were similar across countries; bone pain was the most common presentation. Median duration of first-line therapy was 6 months, followed by a median treatment-free interval of 10 months; both these decreased with increasing lines of therapy, as did time to progression. Depth of response, as assessed by the treating physician, also decreased with each additional line of therapy: 74% of patients achieved at least a very good partial response at first line, compared with only 11% at fifth line. Deeper responses were associated with longer time to progression, although these were physician-judged. Toxicities and co-morbidities increased with later treatment lines, and were more likely to have led to discontinuation of treatment. These real-world data provide an insight into patient outcomes and treatment decisions being made in clinical practice.
| S-EPMC5096152 | biostudies-literature
Project description:BACKGROUND:Telavancin-a lipoglycopeptide antibacterial agent active against Gram-positive pathogens including methicillin-sensitive and -resistant Staphylococcus aureus (MRSA)-is approved in the USA for once-daily intravenous use. This registry study captured patient characteristics, prescribing patterns, and treatment outcomes associated with telavancin use in real-world clinical practice. OBJECTIVE:This prospective, multicenter, observational study will characterize current real-world practice patterns for the use of telavancin in the USA by describing demographic and clinical conditions, examining the process of care and rationale for use, and describing the clinical effectiveness and selected safety outcomes among patients treated with telavancin. METHODS:The Telavancin Observational Use Registry (TOUR™) is an observational multicenter registry study. Clinical data-including patient demographics, pathogens, telavancin dosing and treatment duration, and adverse events-along with investigators' assessments of outcome, were collected through retrospective medical chart review. RESULTS:Data from 1063 patients were collected from 45 US sites. Of these patients, 29.4% were???65 years of age [mean age?±?standard deviation, 55.2?±?15.4 years; median age (interquartile range), 57.0 (46.0-66.0)], 53.4% were male, and 83.4% were White. The primary infections in these patients included complicated skin and skin-structure infection (48.7%), bone and joint infections (27.4%), bacteremia and endocarditis (14.2%), and lower respiratory tract infections (8.5%). The predominant pathogen identified was MRSA (37.7%). The mean telavancin dose and duration of treatment were 741.7?±?194.3 mg and 17?±?17 days, respectively. Of the 964 (90.7%) patients for whom an end-of-treatment assessment was available, 77.7% had a positive clinical response, 10.1% failed treatment, and 12.2% had indeterminate outcomes. CONCLUSIONS:Real-world data collected from the TOUR study show once-daily telavancin is being used for the treatment of a variety of Gram-positive infections with generally positive clinical outcomes.
| S-EPMC6879699 | biostudies-literature