BACKGROUND: INSECT is an internationally registered, three-armed, multicentre, intraoperatively randomised model trial of the Study Centre of the German Surgical Society. The interventions being compared are running suture technique with slowly absorbable monofilament suture material (PDS vs MonoPlus) and interrupted technique with a braided, rapidly absorbable suture material (Vicryl). The primary endpoint is the rate of incisional hernias 1 year postoperatively. MATERIAL AND METHODS:A total of 25 surgeons from 24 different institutions at all levels of care evaluated the theoretical and practical sessions of the surgical investigator meeting using 25 criteria, including course organisation, content, and speaker evaluation, and a categorical grading system from 1 (very good) to 6 (insufficient). RESULTS: Distribution of the 625 grades was: very good (1) n=367, good (2) n=207, satisfactory (3) n=39, adequate (4) n=2, and "No statement" n=10. The average score for the investigator meeting was 1.5. CONCLUSION: The participants felt they were successfully prepared theoretically and practically for trial interventions and conduct by attending the meeting. Clear explanation of the measures for treatment equivalence before and during trials is mandatory in randomised controlled surgical trials.
RCT Entities:
BACKGROUND: INSECT is an internationally registered, three-armed, multicentre, intraoperatively randomised model trial of the Study Centre of the German Surgical Society. The interventions being compared are running suture technique with slowly absorbable monofilament suture material (PDS vs MonoPlus) and interrupted technique with a braided, rapidly absorbable suture material (Vicryl). The primary endpoint is the rate of incisional hernias 1 year postoperatively. MATERIAL AND METHODS: A total of 25 surgeons from 24 different institutions at all levels of care evaluated the theoretical and practical sessions of the surgical investigator meeting using 25 criteria, including course organisation, content, and speaker evaluation, and a categorical grading system from 1 (very good) to 6 (insufficient). RESULTS: Distribution of the 625 grades was: very good (1) n=367, good (2) n=207, satisfactory (3) n=39, adequate (4) n=2, and "No statement" n=10. The average score for the investigator meeting was 1.5. CONCLUSION: The participants felt they were successfully prepared theoretically and practically for trial interventions and conduct by attending the meeting. Clear explanation of the measures for treatment equivalence before and during trials is mandatory in randomised controlled surgical trials.
Authors: P J Devereaux; Mohit Bhandari; Mike Clarke; Victor M Montori; Deborah J Cook; Salim Yusuf; David L Sackett; Claudio S Cinà; S D Walter; Brian Haynes; Holger J Schünemann; Geoffrey R Norman; Gordon H Guyatt Journal: BMJ Date: 2005-01-08
Authors: Hanns-Peter Knaebel; Markus K Diener; Moritz N Wente; Hartwig Bauer; Markus W Büchler; Matthias Rothmund; Christoph M Seiler Journal: Langenbecks Arch Surg Date: 2005-02-22 Impact factor: 3.445
Authors: Hanns-Peter Knaebel; Moritz Koch; Stefan Sauerland; Markus K Diener; Markus W Büchler; Christoph M Seiler Journal: BMC Surg Date: 2005-03-08 Impact factor: 2.102
Authors: Nuh N Rahbari; Phillip Knebel; Markus K Diener; Christoph Seidlmayer; Karsten Ridwelski; Hartmut Stöltzing; Christoph M Seiler Journal: BMC Surg Date: 2009-05-15 Impact factor: 2.102
Authors: Lars Fischer; Petra Baumann; Johannes Hüsing; Christoph Seidlmayer; Markus Albertsmeier; Annette Franck; Steffen Luntz; Christoph M Seiler; Hanns-Peter Knaebel Journal: BMC Surg Date: 2008-07-21 Impact factor: 2.102