[Operative standardization in randomized controlled surgical trials. Meeting of the INSECT trial].
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.


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.


CONCLUSIONS
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.
Knaebel
H-P
HP
Studienzentrum der Deutschen Gesellschaft für Chirurgie Heidelberg.
Kirschner
M H
MH
Reidel
M A
MA
Büchler
M W
MW
Seiler
C M
CM
D034861:Abdominal Wall / Q000601:surgery*; D000818:Animals; D002985:Clinical Protocols / Q000592:standards*; D046449:Hernia, Abdominal / Q000209:etiology*; D006801:Humans; D023421:Models, Animal; D016687:Polydioxanone / Q000592:standards*; D011098:Polyglactin 910 / Q000592:standards*; D011183:Postoperative Complications / Q000209:etiology*; D015397:Program Evaluation; D011786:Quality Control; D012108:Research Personnel / Q000193:education*; D013192:Staff Development / Q000592:standards*; D013503:Surgery Department, Hospital; D013529:Surgical Wound Dehiscence / Q000209:etiology*; D013536:Suture Techniques / Q000592:standards*; D013537:Sutures / Q000592:standards*; D013552:Swine
D016687:Polydioxanone; D011098:Polyglactin 910