Annals of surgery
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters.
Vertical banded gastroplasty (VBGP) was compared with Roux-en-Y gastric bypass (RYGBP) in a randomized prospective trial that included preoperative dietary separation of "sweets eaters" versus "non-sweets eaters." Randomization was stopped at 9 months after 20 patients had undergone each procedure because a greater weight loss (p less than 0.05) was noted after RYGBP than VBGP. This difference became more significant (p less than 0.001) at each 3-month interval through 3 years, when patients who had VBGPs had lost 37 +/- 20% of excess weight compared with 64 +/- 19% for patients who had RYGBPs. The members of the groups were comparable with regard to age, sex, eating habits, morbidity rates before surgery, ideal body weight, and weight before surgery. ⋯ RYGBP was clearly superior to VBGP for "sweets eaters," probably because of the development of dumping syndrome symptoms. However, RYGBP was associated with a larger number of correctable problems. Thus, it is important to evaluate a patient's eating habits before surgery for morbid obesity; "non-sweets eaters" probably should be treated with VBGP and "sweets eaters" with RYGBP.
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Randomized Controlled Trial Clinical Trial
Prophylactic platelet administration during massive transfusion. A prospective, randomized, double-blind clinical study.
Prior studies at Harborview Medical Center have suggested that dilutional thrombocytopenia is a major etiology of microvascular, nonmechanical bleeding (MVB). We undertook a prospective randomized double-blind clinical study to compare the prophylactic effects of 6 units of platelet concentrates (PLT) versus 2 units of fresh frozen plasma (FFP) administered with every 12 units of modified whole blood in patients undergoing massive transfusion (12 or more units in 12 hours). ⋯ Only one patient had evidence of dilutional thrombocytopenia as a cause for MVB. Prophylactic platelet administration is not warranted as a routine measure to prevent MVB.
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Randomized Controlled Trial Clinical Trial
Evaluation of antibiotic therapy following penetrating abdominal trauma.
Postoperative infection accounts for significant morbidity and mortality following penetrating abdominal trauma. During a 2 1/2-year period, December 1980 through June 1983, 257 patients sustaining penetrating abdominal injury were initially treated at Parkland Memorial Hospital in Dallas. Following the patient's written consent, they were prospectively randomized to receive, prior to surgery, intravenous clindamycin 600 mg every 6 hours and tobramycin 1.2 mg/kg every 6 hours (CT), or cefamandole 1 gm every 4 hours (M), or cefoxitin 1 gm every 4 hours (C). ⋯ The results of this study indicate that cefoxitin is comparable to the combination of clindamycin/tobramycin and superior to cefamandole when used before surgery in patients sustaining penetrating abdominal trauma. The study suggests that antibiotic coverage should be against aerobes and anaerobes. Routine administration of an aminoglycoside is unnecessary.
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Randomized Controlled Trial Clinical Trial
A single institution, randomized, prospective trial of cyclosporin versus azathioprine-antilymphocyte globulin for immunosuppression in renal allograft recipients.
Between September 26, 1980 and December 31, 1983, 230 splenectomized, transfused renal allograft recipients were randomized to treatment with either cyclosporin-prednisone (N = 121, 68 diabetic and 53 nondiabetic recipients; 73 cadaver and 48 related donor grafts) or azathioprine-prednisone-antilymphocyte globulin (N = 109, 61 diabetic and 48 nondiabetic recipients; 69 cadaver and 40 related donor grafts). The results were analyzed on March 31, 1984. Actuarial patient survival rates at 2 years were 88% in the cyclosporin and 91% in the azathioprine groups (p = 0.649). ⋯ D.) serum creatinine levels (mg/dl) at 1 year were higher in cyclosporin (2.0 +/- 0.6) than in azathioprine (1.5 +/- 0.5) treated recipients (p = less than 0.001). A reduction in cyclosporin dose because of nephrotoxicity was required in 96 of the cyclosporin-treated patients (70%), and 25 were switched to treatment with azathioprine (21%). The incidence of all infections in cyclosporin-treated patients was approximately half of that in azathioprine-treated patients, and only nine per cent of the cyclosporin-treated patients were diagnosed to have cytomegalovirus infections during the first post-transplant year vs. 28% in azathioprine-treated patients (p = 0.002).(ABSTRACT TRUNCATED AT 400 WORDS)
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Randomized Controlled Trial Comparative Study Clinical Trial
Clinical risk factors for prolonged PT/PTT in abdominal sepsis patients treated with moxalactam or tobramycin plus clindamycin.
Factors associated with prolongation of the prothrombin time were analyzed in 94 patients with intra-abdominal sepsis. Patients were randomized prospectively to receive either the combination of tobramycin and clindamycin (TM/C) or moxalactam (MOX). This paper presents a retrospective review designed to compare the frequency of prolonged clotting times and to analyze predisposing factors. ⋯ In view of underlying abnormalities and rapid response to parenteral vitamin K, the mechanism is probably an acute vitamin K deficiency superimposed upon chronic vitamin K deficiency. In patients with intra-abdominal infection, those treated with MOX are more likely to develop abnormal PT than those treated with TM/C. Since abnormal PT/PTT was common even in TM/C patients, supplemental vitamin K should be considered for all seriously ill, older patients with abdominal infections.