Surgery
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Randomized Controlled Trial
The impact of heat stress on operative performance and cognitive function during simulated laparoscopic operative tasks.
Increasing ambient temperature to prevent intraoperative patient hypothermia remains widely advocated despite unconvincing evidence of efficacy. Heat stress is associated with decreased cognitive and psychomotor performance across multiple tasks but remains unexamined in an operative context. We assessed the impact of increased ambient temperature on laparoscopic operative performance and surgeon cognitive stress. ⋯ Increasing ambient temperature to levels advocated for prevention of intraoperative hypothermia does not greatly decrease technical performance in short operative tasks. Surgeons, however, do report increased perceptions of distraction and physical demand. The impact of these findings on performance and outcomes during longer operative procedures remains unclear.
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Randomized Controlled Trial
Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.
Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study. ⋯ The CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.
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Randomized Controlled Trial
Effect of intraoperative infiltration with local anesthesia on the development of chronic pain after inguinal hernia repair: a randomized, triple-blinded, placebo-controlled trial.
Chronic pain is a common complication after inguinal hernia repair. The objective of this randomized trial was to assess the effect of intraoperative infiltration with local anesthetic versus placebo on the development of chronic pain after inguinal hernia repair. ⋯ We did not find any evidence that intraoperative infiltration of local anesthetic had an impact on the development of chronic postoperative pain.
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Randomized Controlled Trial
The effects of acupuncture after thyroid surgery: A randomized, controlled trial.
Acupuncture is a safe and well-tolerated treatment for pain relief. Previous studies supported the effectiveness of several acupuncture techniques for postoperative pain. The aim of this randomized, controlled trial was to evaluate the efficacy of acupuncture in reducing pain after thyroid surgery. ⋯ Acupuncture may be effective in reducing pain after thyroid surgery. EA is more useful; TA achieves no significant effects.
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Randomized Controlled Trial Multicenter Study Comparative Study
A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery.
This prospective, multicenter, randomized clinical trial was performed to compare the effectiveness of the bioprosthesis Surgisis Gold (Cook Biotech, Inc, West Lafayette, IN) to suture closure alone in reinforcing the abdominal wall after open Roux-en-Y gastric bypass (RYGB). ⋯ In this challenging patient population, the use of Surgisis Gold for reinforcing the abdominal wall after open RYGB was not shown to be greatly different from a primary suture repair.