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[Operative standardization in randomized controlled surgical trials. Meeting of the INSECT trial]
H-P Knaebel1, M H Kirschner, M A Reidel
1Studienzentrum der Deutschen Gesellschaft für Chirurgie Heidelberg.
Der Chirurg; Zeitschrift Fur Alle Gebiete Der Operativen Medizen
|February 24, 2006
Summary
Surgeons felt well-prepared for the INSECT trial after the investigator meeting. Clear explanations of treatment equivalence are crucial for randomized controlled surgical trials.
Area of Science:
- Surgical research methodology
- Clinical trial design
- Medical education
Background:
- The INSECT trial is a multicentre, randomized surgical trial comparing suture techniques for incisional hernia prevention.
- Interventions include running sutures (PDS vs. MonoPlus) and interrupted sutures (Vicryl).
- The primary endpoint is the 1-year postoperative incisional hernia rate.
Purpose of the Study:
- To assess surgeon preparedness for the INSECT trial interventions and conduct.
- To evaluate the effectiveness of the surgical investigator meeting.
- To highlight the importance of clear communication in surgical trials.
Main Methods:
- 25 surgeons from 24 institutions evaluated the investigator meeting.
- Evaluation used 25 criteria covering organization, content, and speakers.
- A grading system from 1 (very good) to 6 (insufficient) was employed.
Main Results:
- The average score for the investigator meeting was 1.5 (very good).
- 367 participants rated the meeting as 'very good' (1), and 207 as 'good' (2).
- 10 participants provided no statement.
Conclusions:
- Participants reported successful theoretical and practical preparation for trial interventions.
- Effective preparation is linked to clear explanations of treatment equivalence measures.
- This underscores the necessity of clear communication protocols in randomized controlled surgical trials.