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Based on safety data from phase 2, it was agreed to proceed to phase 3. Between January 31 and November 14, 2017, an additional 63 patients were randomized inazid phase 3. Four patients were not were operated on and were excluded from the analyses. After randomization of 105 people combining subjects from phase 2 and 3, of whom 99 underwent surgery, the trial was stopped prematurely due to a difference in mortality related to complications over 90 days five 10 of 50 patients in the laparoscopic pancreatoduodenectomy group versus one 2 of 49 in the open pancreatoduodenectomy group; risk ratio RR 4.
90 95 CI 0. 59 - 40. -44 ; p0-20. The median time to functional recovery was 10 days 95 CI 5 to 15 after the laparoscopic procedure versus 8 days 95 CI 7 to 9 after the open intervention log-rank p 0 ,80. Complications of Clavien-Dindo grade III or higher 25 50 of 50 patients after laparoscopy versus 19 39 of 49 after open surgery; RR 1. 29 95 CI 0. 82 - 2. 02; p 0. 26 and postoperative grade BC pancreatic fistulas 14 28 versus 12 24; RR 1. 14 95 CI 0. 59 - 2. 22; p0-69 were ecoflox between the groups. Hilde de Clerck We work on many aspects contact tracing, epidemiological investigation, health promotion, psychology, isolation, medical care, ambulance, decontamination of houses, burials. Tasks are partly taken care of by other actors but these teams are also small and do not always have the necessary experience.
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