Annals of surgery
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Randomized Controlled Trial Multicenter Study
Perioperative intravenous glutamine supplemetation in major abdominal surgery for cancer: a randomized multicenter trial.
To investigate whether perioperative intravenous glutamine supplementation may affect surgical morbidity. ⋯ Perioperative glutamine does not affect outcome in well-nourished GI cancer patients.
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Randomized Controlled Trial Multicenter Study Comparative Study
Ten-year outcome of laparoscopic and conventional nissen fundoplication: randomized clinical trial.
To compare 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF), with focus on effectiveness and reoperation rate. ⋯ CNF carries a higher risk for surgical reintervention compared with LNF, mainly due to incisional hernia corrections. The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control. Consequently, the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD.
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Randomized Controlled Trial Comparative Study
Biliary reconstruction using a side-to-side choledochocholedochostomy with or without T-tube in deceased donor liver transplantation: a prospective randomized trial.
The biliary anastomosis is still one of the major causes for morbidity after orthotopic liver transplantation. The optimal method of reconstruction remains controversial. The aim of the study was to assess biliary complications after liver transplantation using a choledochocholedochostomy with or without a temporary T-tube. ⋯ This study is a large prospective randomized trial to assess biliary complications that occur following liver transplantation, after anatomizing the bile duct with or without T-tubes. A significant increased rate of complications in the group without T-tube insertion was observed. In summary, our results indicate that the usage of T-tubes is safe and an excellent tool for the quality control of biliary anastomoses.
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Randomized Controlled Trial
Randomized controlled trial to determine the efficacy of long-term growth hormone treatment in severely burned children.
Recovery from a massive burn is characterized by catabolic and hypermetabolic responses that persist up to 2 years and impair rehabilitation and reintegration. The objective of this study was to determine the effects of long-term treatment with recombinant human growth hormone (rhGH) on growth, hypermetabolism, body composition, bone metabolism, cardiac work, and scarring in a large prospective randomized single-center controlled clinical trial in pediatric patients with massive burns. ⋯ This large prospective clinical trial showed that long-term treatment with rhGH effectively enhances recovery of severely burned pediatric patients.
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Randomized Controlled Trial Comparative Study
Portal-systemic encephalopathy in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt treatment of acutely bleeding esophageal varices in cirrhosis.
In patients with cirrhosis and bleeding esophageal varices, there is a widespread belief that control of bleeding by portal-systemic shunts is compromised by a high incidence of shunt-related portal-systemic encephalopathy (PSE). This important issue was examined by a randomized controlled trial that compared emergency and long-term endoscopic sclerotherapy (EST) to emergency direct portacaval shunt (EPCS) in patients with cirrhosis and acute variceal hemorrhage. ⋯ In contrast to EST, EPCS permanently controlled variceal bleeding, resulted in significantly greater long-term survival, and was followed by a relatively low (15%) incidence of PSE. These results were facilitated by rigorous, frequent, and lifelong follow-up that included regular counseling on dietary protein restriction and abstinence from alcohol, and by long-term patency of the portacaval shunt in 98% of patients. Furthermore, these results call into question the practice of avoiding portacaval shunt because of fear of PSE, and thereby foregoing the lifesaving advantage achieved by surgical control of bleeding. (clinicaltrials.gov NCT00690027).