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document
Randomised multicentre trial of circular stapling devices . PURPOSE In a register study , the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4 % difference between the two brands used . Based on those data , a randomised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device . METHODS Patients above 18 years with a rectal cancer , able to give informed consent , and scheduled for an anterior resection were eligible for the study . Perioperative randomisation was to Ethicon™ PROXIMATE™ ILS™ or Autosuture™ Premium Plus CEEA™ . Anastomotic leakage was defined as a clinically manifest leak . RESULTS Five hundred twenty-nine patients were randomised ( 58 % male ) . A leak occurred in 8.3 % . The anastomoses created by PROXIMATE™ ILS™ leaked in 25/265 ( 9.4 % ) anastomoses , and the Premium Plus CEEA™ leaked in 19/260 ( 7.3 % ) , p = .419 . CONCLUSION No difference in the leak rate could be revealed . Several centres replaced one of the staplers by a new product , and the study was ended before the stipulated number of patients was reached . In the future , surgical devices may have to prove superiority in randomised trials or be monitored in quality registers before they can be introduced into day to day surgical practice . The study was registered at ClinicalTrials.gov : NCT00399009 .
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Intervention_Other
circular stapling devices
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Intervention_Other
circular stapling device
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Intervention_Surgical
surgical device
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Outcome_Physical
anastomotic leakage
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Outcome_Physical
anastomotic leakage
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Participant_Age
18 years
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Participant_Condition
rectal cancer
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Participant_Condition
able to give informed consent
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Participant_Condition
scheduled for an anterior resection
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Participant_Condition
leak
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Participant_Sample-size
Five hundred twenty-nine