Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial

<p>Abstract</p> <p>Background</p> <p>Secondary hyperparathyroidism (sHPT) is common in patients with chronic renal failure. Despite the initiation of new therapeutic agents, several patients will require parathyroidectomy (PTX). Total PTX with autotransplantation of parathyroid tissue (TPTX+AT) and subtotal parathyroidectomy (SPTX) are currently considered as standard surgical procedures in the treatment of sHPT. Recurrencerates after TPTX+AT or SPTX are between 10% and 12% (median follow up: 36 months).</p> <p>Recent retrospective studies demonstrated a lower rate of recurrent sHPT of 0–4% after PTX without autotransplantation and thymectomy (TPTX) with no higher morbidity when compared to the standard procedures. The observed superiority of TPTX is flawed due to different definitions of outcomes, varying follow up periods and different surgical treatment strategies (with and without thymectomy).</p> <p>Methods/Design</p> <p>Patients with sHPT (intact parathyroid hormone > 10 times above the upper limit of normal) on long term dialysis (>12 months) will be randomized either to TPTX or TPTX+AT and followed for 36 months. Outcome parameters are recurrence rates of sHPT, frequencies of reoperations due to refractory hypoparathyroidism or recurrent/persistent hyperparathyroidism, postoperative morbidity and mortality and quality of life. 50 patients per group will be randomized in order to obtain relevant frequencies of outcome parameters that will form the basis for a large scale confirmatory multicentred randomized controlled trial.</p> <p>Discussion</p> <p>sHPT is a disease with a high incidence in patients with chronic renal failure. Even a small difference in outcomes will be of clinical relevance. To assess sufficient data about the rate of recurrent sHPT after both methods, a multicentred, randomized controlled trial (MRCT) under standardized conditions is mandatory.</p> <p>Due to the existing uncertainties the calculated number of patients necessary in each treatment arm (n > 4000) makes it impossible to perform this study as a confirmatory trial. Therefore estimates of different outcomes are performed using a pilot MRCT comparing 50 versus 50 randomized patients in order to establish a hypothesis that can be tested thereafter.</p> <p>If TPTX proves to have a lower rate of recurrent sHPT, no relevant disadvantages and no higher morbidity than TPTX+AT, current surgical practice may be changed.</p> <p>Trial registration</p> <p>International Standard Randomized Controlled Trial Number Registration (ISRCTN86202793)</p

Bacteriological Quality of Fresh Vegetables Salad Sold in Schools Canteens and Restaurants in Gaza Strip-Palestine

This research aimed to investigate the bacteriological quality of fresh vegetables salad sold in the local school canteens and restaurants in Gaza strip, Palestine. Samples examined included different types of fresh vegetables salad. A total of 200 random samples were collected from school canteens (100 samples) and different restaurants (100 samples) in Mid Zone, Khan Younis and Rafah governorates during the period from April to June 2013. All samples were examined for Total Plate Count, Total Coliform bacteria, Escherichia coli, Staphylococcus aureus, Bacillus cereus, Listeria spp., L. monocytogenes, Salmonella spp., Shigella spp., and E. coli O157:H7. Eighty eight percentage of vegetables salad samples failed to comply with Guidelines for the microbiological examination of ready-to-eat foods, Food Standards Australia New Zealand. The percentage of failure is distributed as follows; 79.5% with Total Plate Count, 60.5% with Total Coliform bacteria, 53.5% with E. coli, 21.5% with S. aureus, 14% B. cereus, 7.5% Listeria spp., 2% L. monocytogenes, 5% Salmonella spp., 1%&nbsp; Shigella spp., and 1% E. coli O157:H7. In this study the mixed vegetables salad samples were showed the highest non-compliant. Moreover, several potential pathogens were isolated; Cronobacter sakazakii (12.5%; 25), Pasteurella spp. (3%; 6) and Aeromonas hydrophila (0.5%; 1). The results indicated that the tested vegetables salads had poor microbiological quality, and could act as a vehicle for food-borne pathogens such as Salmonella spp., Shigella spp., E. coli O157:H7 and L. monocytogenes, which justifies the necessity for the urgent actions to promote awareness about the possible health hazards