Annals of surgery
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Randomized Controlled Trial
Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study.
Sentinel node biopsy (SNB) is widely used to stage the axilla in breast cancer. We present 10-year follow-up of our single-institute trial designed to compare outcomes in patients who received no axillary dissection if the sentinel node was negative, with patients who received complete axillary dissection. ⋯ Preservation of healthy lymph nodes may have beneficial consequences. Axillary dissection should not be performed in breast cancer patients without first examining the sentinel node.
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Randomized Controlled Trial Multicenter Study Comparative Study
Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial).
The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. ⋯ There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.
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Randomized Controlled Trial Comparative Study
Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial.
The optimal transfusion threshold after surgery in children is unknown. We analyzed the general surgery subgroup of the TRIPICU (Transfusion Requirements in Pediatric Intensive Care Units) study to determine the impact of a restrictive versus a liberal transfusion strategy on new or progressive multiple organ dysfunction syndrome (MODS). ⋯ In this subgroup analysis of pediatric general surgery patients, we found no conclusive evidence that a restrictive red-cell transfusion strategy, as compared with a liberal one, increased the rate of new or progressive MODS or mortality.
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Randomized Controlled Trial
Erythropoiesis stimulating agent administration improves survival after severe traumatic brain injury: a matched case control study.
Erythropoiesis stimulating agent (ESA) administration may reduce mortality in severe traumatic brain injury (sTBI). ⋯ Erythropoiesis stimulating agent administration in sTBI is associated with a significant in-hospital survival advantage without increase in morbidity. Prospective validation of our findings is warranted.
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.
Continuous intravenous infusion of somatostatin improves the natural course of digestive fistulae. Lanreotide 30 mg PR is a synthetic analogue of somatostatin with pharmacological activity extending to at least 10 days after intramuscular administration. Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study. ⋯ Compared with placebo, intramuscular lanreotide 30 mg PR significantly decreases digestive fistulae output at Day 3 and shortens time to fistula closure by 9 days. ClinicalTrials.gov registration number: NCT00729313.