Multi-Centre European Experience with Intragastric Balloon in Overweight Populations: 13 Years of Experience

Background

The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients.

Methods

Patients (BMI 27–30 kg/m²) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities.

Results

A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54 %). Mean body mass index (BMI) fell from 28.6?±?0.4 at baseline to 25.4?±?2.6 kg/m² at 6 months and to 27.0?±?3.1 kg/m² at 3 years from BIB removal. The mean %EWL was 55.6 % at 6 months and 29.1 % at 3 years. Forty-seven patients (18 %) had complications associated with placement of the intragastric balloon (leak?=?28, intolerance?=?14, duodenal ulcer?=?2, gastritis?=?1, oesophagitis?=?1, duodenal polyps?=?1). The rate of patients with hypertension decreased from 29 % at baseline to 16 % at 3 years. Diabetes decreased from 15 to 10 %, dyslipidaemia decreased from 20 to 18 %, hypercholesterolaemia decreased from 32 to 21 % and osteoarthropathy decreased from 25 to 13 %.

Conclusions

The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.     

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

Background

The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials.

Objective

To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery.

Design, setting, and participants

From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group.

Intervention

All RARP and LRP interventions were performed with the same technique by the same single surgeon.

Outcome measurements and statistical analysis

The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, χ² test, Pearson χ² test, and multiple regression analysis were used for statistics.

Results and limitations

The two groups (RARP: n = 60; LRP: n = 60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p = 0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p = 0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p = 0.020). The limitations included the small number of patients.

Conclusions

RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results.     

The loss of extension test (LOE test): a new clinical sign for the anterior cruciate ligament insufficient knee

Background

This prospective study was created to evaluate the reliability of a new clinical test, which we termed the “loss of extension test” (LOE test). The LOE test investigates the loss of normal maximum passive extension (MPE) of the knee due to an anterior cruciate ligament tear in comparison to the normal MPE of the healthy knee.

Materials and methods

The study was divided into two consecutive parts. Part 1 was designed to assess the side-to-side difference in normal MPE in a healthy population. In part 1, 100 healthy adults were enrolled. Part 2 was designed to evaluate the LOE test reliability in injured knees. In part 2, we included 196 selected patients.

Results

In part 1, the average side-to-side difference in MPE in the healthy population was not statistically significant. In part 2, the overall average side-to-side difference in MPE of the injured group was 10.1 mm ± 14.1 (min −20; max 60), which was not statistically significant (p = 0.52). An anterior cruciate ligament (ACL) tear was found in 121 knees among 196 patients. The average side-to-side difference in MPE in the ACL-insufficient group was 16.9 mm ± 13.4 (min −20; max 60), which was statistically significant (p < 0.0001). The accuracy of the loss of extension test was 83.7 %, its specificity was 93.3 %, its sensitivity was 77.7 %, its positive predictive value was 95 %, and its negative predictive value was 72.2 %.

Conclusions

The reliability of the LOE test is comparable to those reported in the literature for the Lachman test and dynamic tests, so the LOE test could represent a useful tool for the diagnosis of the anterior cruciate ligament insufficient knee.     

Immediate loading of mandibular overdentures supported by unsplinted direct laser metal-forming implants: results from a 1-year prospective study

Background: At present, only some studies have dealt with immediate loading of unsplinted implants supporting mandibular overdentures. The aim of this prospective study is to evaluate treatment outcomes of mandibular overdentures supported by four one‐piece, unsplinted, immediately loaded, direct laser metal‐forming (DLMF) implants by assessing implant survival rate, implant success, marginal bone loss, and prosthetic complications. Methods: A total of 96 one‐piece DLMF implants were inserted in the edentulous mandible of 24 patients. Four implants were placed in each edentulous mandible. Immediately after implant placement, a mandibular overdenture was connected to the implants. At 1‐year follow‐up, clinical, radiographic, and prosthetic parameters were assessed. Success criteria included absence of pain, suppuration, and implant mobility; absence of continuous peri‐implant radiolucency; and distance between the implant shoulder and the first visible bone contact <1.5 mm. Results: After a 1‐year loading time, the overall implant survival rate was 98.9%, with only one implant lost. Among the surviving 95 implants, two did not fulfill the success criteria; therefore, the implant success rate was 97.8%. The mean distance between the implant shoulder and the first visible bone contact was 0.28 ± 0.30 mm (95% confidence interval, 0.24 to 0.32). Some prosthetic complications were reported. Conclusion: Based on the present results and within the limits of this study, the immediate loading of four unsplinted DLMF implants by means of ball attachment–supported mandibular overdentures seems to represent a safe and successful procedure.     

How to improve reading skills in dyslexics: The effect of high frequency rTMS

The latest progress in understanding remediation of dyslexia underlines how some changes in brain are a necessary mechanism of improvement. We wanted to determine whether high frequency repetitive transcranial magnetic stimulation (hf-rTMS) over areas that are underactive during reading in dyslexics, would improve reading of dyslexic adults. We applied 5Hz-TMS over both left and right inferior parietal lobule (IPL) and superior temporal gyrus (STG) prior to word, non-word and text reading aloud.     

Distinctive clinical and neuroimaging characteristics of longitudinally extensive transverse myelitis associated with aquaporin-4 autoantibodies

Longitudinally extensive transverse myelitis (LETM) is a characteristic feature of Neuromyelitis Optica (NMO), but it can also occur in several other inflammatory diseases of the central nervous system (CNS). An IgG autoantibody that binds to aquaporin-4 (AQP4), the predominant water channel of the CNS, is a reliable biomarker of the NMO spectrum disorders, and if detected predicts the recurrence of the myelitis. In this study, we compared the clinical and neuroimaging characteristics of AQP4-IgG+ and AQP4-IgG? LETM patients. Thirty-seven first-ever LETM patients were retrospectively evaluated and divided into two groups according to the presence of AQP4 autoantibodies. AQP4-IgG was detected in the serum and in the cerebrospinal fluid of sixteen patients. The female to male ratio was higher in AQP4-IgG+ patients. Intractable nausea and vomiting and paroxysmal tonic spasms often accompanied the LETM in AQP4-IgG+ patients. T2-weighted spinal cord MRI revealed that inflammatory lesions extending into the brainstem and involving the central grey matter occurred more frequently in AQP4-IgG+ LETM patients. Hypointense lesions on T1-weighted spinal cord MRI were detected more frequently in the seropositive group, and their presence correlated with attack severity. In conclusion, this study provides clinical and spinal cord neuroimaging clues that can help distinguishing AQP4-IgG+ LETM patients.     

Transcranial direct current stimulation and cognitive training in the rehabilitation of Alzheimer disease: A case study

In the present study we tested the cognitive effects of transcranial direct current stimulation (tDCS) in a case of probable Alzheimer disease (AD). The patient (male, 60?years, mild AD) underwent two cycles of treatments, separated by 2?months. In the first cycle, active stimulation (10 sessions, 2?mA for 20?min; anode over the left dorsolateral prefrontal cortex) was followed by computerised tasks (CTs) specifically chosen to engage the most impaired cognitive processes in the patient (tDCS+CT condition). In the second cycle, which was structured as the first, CTs were administered after placebo stimulation (sham+CT condition). Effects on cognitive performance were evaluated not only by the CTs, but also by neuropsychological tests assessing global cognitive functioning. Statistical analyses revealed that whereas the tDCS+CT condition had few effects on the CTs, it induced a stability of the patient's global cognitive functioning lasting approximately 3?months, which was not achieved when the patient underwent sham+CT condition. Therefore, the synergetic use of tDCS and CTs appeared to slow down the cognitive decline of our patient. This preliminary result, although in need of further confirmation, suggests the potentiality of tDCS as an adjuvant tool for cognitive rehabilitation in AD.