Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study

Background

Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse?, a procedureless gastric balloon.

Methods

Eight patients (mean BMI?=?31.0 kg/m²) participated in this study. Each patient swallowed one Elipse? balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed.

Results

All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities.

Conclusions

This pilot study demonstrates the safety and performance of Elipse?, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

     

Hematopoietic growth factors for graft failure after bone marrow transplantation: a randomized trial of granulocyte-macrophage colony- stimulating factor (GM-CSF) versus sequential GM-CSF plus granulocyte- CSF

Delay in hematologic recovery after bone marrow transplantation (BMT) can extend and amplify the risks of infection and hemorrhage, compromise patients' survival, and increase the duration and cost of hospitalization. Because current studies suggest that granulocyte- macrophage (GM) colony-stimulating factor (CSF) may potentiate the sensitivity of hematopoietic progenitor cells to G-CSF, we performed a prospective, randomized trial comparing GM-CSF (250 micrograms/m2/d x 14 days) versus sequential GM-CSF x 7 days followed by G-CSF (5 micrograms/kg/d x 7 days) as treatment for primary or secondary graft failure after BMT. Eligibility criteria included failure to achieve a white blood cell (WBC) count > or = 100/microL by day +21 or > or = 300/microL by day +28, no absolute neutrophil count (ANC) > or = 200/microL by day +28, or secondary sustained neutropenia after initial engraftment. Forty-seven patients were enrolled: 23 received GM-CSF (10 unrelated, 8 related allogeneic, and 5 autologous), and 24 received GM- CSF followed by G-CSF (12 unrelated, 7 related allogeneic, and 5 autologous). For patients receiving GM-CSF alone, neutrophil recovery (ANC > or = 500/microL) occurred between 2 and 61 days (median, 8 days) after therapy, while those receiving GM-CSF+G-CSF recovered at a similar rate of 1 to 36 days (median, 6 days; P = .39). Recovery to red blood cell (RBC) transfusion independence was slow, occurring 6 to 250 days (median, 35 days) after enrollment with no significant difference between the two treatment groups (GM-CSF: median, 30 days; GM-CSF+G- CSF; median, 42 days; P = .24). Similarly, platelet transfusion independence was delayed until 4 to 249 days (median, 32 days) after enrollment, with no difference between the two treatment groups (GM- CSF: median, 28 days; GM-CSF+G-CSF: median, 42 days; P = .38). Recovery times were not different between patients with unrelated donors and those with related donors or autologous transplant recipients. Survival at 100 days after enrollment was superior after treatment with GM-CSF alone. Only 1 of 23 patients treated with GM-CSF died versus 7 of 24 treated with GM-CSF+G-CSF who died 16 to 84 days (median, 38 days) after enrollment, yielding Kaplan-Meier 100-day survival estimates of 96% +/- 8% for GM-CSF versus 71% +/- 18% for GM-CSF+G-CSF (P = .026). These data suggest that sequential growth factor therapy with GM-CSF followed by G-CSF offers no advantage over GM-CSF alone in accelerating trilineage hematopoiesis or preventing lethal complications in patients with poor graft function after BMT.(ABSTRACT TRUNCATED AT 400 WORDS)     

Results of triple muscle (sartorius,tensor fascia latae and part of gluteus medius) pedicle bone grafting in neglected femoral neck fracture in physiologically active patients

Background:

Femoral neck fractures are notorious for complications like avascular necrosis and nonunion. In developing countries, various factors such as illiteracy, low socioeconomic status, ignorance are responsible for the delay in surgery. Neglected fracture neck femur always poses a formidable challenge. The purpose of this study was to evaluate the results of triple muscle pedicle bone grafting using sartorius, tensor fasciae latae and part of gluteus medius in neglected femoral neck fracture.

Materials and Methods:

This is a retrospective study with medical record of 50 patients, who were operated by open reduction, internal fixation along with muscle pedicle bone grafting by the anterior approach. After open reduction, two to three cancellous screws (6.5 mm) were used for internal fixation in all cases. A bony chunk of the whole anterior superior iliac spine of 1 cm thickness, 1 cm width and 4.5 cm length, taken from the iliac crest comprised of muscle pedicle of sartorius, tensor fascia latae and part of gluteus medius. Then the graft with all three muscles mobilized and put in the trough made over the anterior or anterosuperior aspect of the femoral head. The graft was fixed with one or two 4.5 mm self-tapping cortical screw in anterior to posterior direction.

Results:

14 patients were lost to followup. The results were based on 36 patients. We observed that in our series, there was union in 34, out of 36 (94.4%) patients. All patients were within the age group of 15-51 years (average 38 years) with displaced neglected femoral neck fracture of ≥30 days. Mean time taken for full clinicoradiological union was 14 weeks (range-10-24 weeks).

Conclusion:

Triple muscle pedicle bone grafting gives satisfactory results for neglected femoral neck fracture in physiologically active patients.     

Trends of Transfusion Transmissible Diseases Among Blood Donors at Uttarakhand,India

Context:

Blood can save lives; however, it can be a source of transfusion transmitted diseases if proper screening of donated blood is not done. It is now mandatory to screen all donated blood units, whether replacement or voluntary for five transfusion transmitted diseases-namely human immunodeficiency virus (HIV), hepatitis B and C, syphilis, and malaria.

Aims:

The present study was done to study the prevalence of infectious disease markers among donors at the blood bank of a tertiary care center.

Settings and Design:

A total of 53,069 donors donated blood over 11 years. The number of replacement and voluntary donors was 41,710 and 11,359, respectively.

Materials and Methods:

Screening of blood units was done by enzyme-linked immunosorbent assay (ELISA) method for HIV and hepatitis B and C. HIV testing was done using fourth generation ELISA kits. Syphilis was tested by latex agglutination assay and malaria was tested using slide method up to the year 2008-2009 and by rapid immunochromatographic assay after that.

Results:

The mean percentage of these infections per year was found to be 0.2, 1.2, 0.9, 0.3, and 0.002% for HIV, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), syphilis, and malarial parasite (MP), respectively.

Conclusions:

The risk of transfusion transmissible infection (TTI) today is low but supply of safe blood depends on proper donor selection and sensitive screening tests.     

Cellular localization of somatostatin mRNA in rat retina

In an attempt to determine the localization of the messenger RNA (mRNA) encoding somatostatin in the rat retina, we studied Sprague-Dawley rats by in situ hybridization histochemistry using radiolabelled oligodeoxyribonucleotides complementary for rat somatostatin mRNA. Among the layers of retina, we found specific labelling in the soma of some cells in the innermost and outermost laminae of the inner nuclear layer and in the ganglion cell layer; no specific labelling was observed in the inner and outer plexiform layers or in the outer nuclear layer. These data indicate the major site of somatostain synthesis within the rat retina.