Page 38 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

Chapter 2
An independent data and safety monitoring committee will evaluate the progress of the trial and will examine safety parameters every 3 months. The committee can unblind the data whenever deemed necessary based on reported adverse events. All involved physicians will repetitively be asked to report any potential adverse events caused by the study protocol. These adverse events will be listed and discussed with the monitoring committee. The monitoring committee can ask for a full report in order to discuss a speci c adverse event. A copy of this report will be sent to the central ethics board and to the involved physicians. All deceased patients will be evaluated by the safety committee for cause of death and possible trial related serious adverse e ects. Every death will be reported to the central ethics board and the local ethics board. The Data Safety Monitoring Board will consist of an epidemiologist/ statistician and two independent surgeons.
Ethics
This study will be conducted in accordance with the principles of the Declaration of Helsinki and ‘good clinical practice’ guidelines. The Medical Ethical Committee of the Erasmus University Medical Center Rotterdam has approved the protocol. The Ethical Committees of the participating centers are applied for local feasibility. Prior to randomization, written informed consent will be obtained from all patients.
Discussion
A major issue in all suture studies is standardisation of technique. In a multicenter trial it is di cult to achieve standardisation because many surgeons and residents will contribute in this trial. The bene t of a large group of participants is that the results will be representable for daily practice.
In this trial two major parameters have been standardized: the di erence between small and large bites and the amount of stitches per running cm of wound resulting in an appropriate SL:WL ratio.
In daily practice, most surgeons use the large bite technique with large suture distances. With large bites, SL:WL ratio depends on the thickness of the abdominal wall including the muscles, the bite size, the number of stitches and the traction on the sutures during suturing. With large bites there is an
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