Study approach: surgical trials mean more safety in the operating room

Whether a surgical suture is better applied manually or with a surgical stapler can be determined through trial and error. Determining which method guarantees patient safety best should also not just be based on a surgeon’s experience. Controlled studies are the method of choice to assess both well-proven and new techniques in the operating room.


Foto: Ärzteteam

Even when an individual came up with the idea - a trial can only be successful when conducted by a team; © Wavebreakmedia ltd

Over the years, surgeons complained that many studies were discontinued, because they were not informed about the option to participate for instance or information was not freely accessible. This is why there have been efforts for some years now to better inform about current studies as well as ensure that quality standards are being met.

A tight network is essential

The Study Center of the German Surgical Society (SDGC) along with CHIR-Net actively work on this endeavor, and who by their own account consider the planning, execution and analysis of multicenter studies on surgical techniques their main goal by collaborating with university facilities, hospitals and practices. They also intend to create an infrastructure for surgical trials. Associate professor Jens Neudecker from CHIR-Net tells that the inquiries by his colleagues on research projects are increasing: "There are many good ideas, but you need a good network to implement a research project. This is why we created local contact centers. Currently we can point to 27 trials; 15 are completed, while the remaining 12 are presently recruiting patients."
Photo: Physicians in the OR

Which surgical technique is the better method? Surgical trials in particular need to be carefully conducted, since a human life is at stake; © Monkeybusiness Images

The results provide help for surgeons on whether one surgical technique is better than another for instance. Neudecker explains: "Currently there is a debate amongst surgeons on whether antiseptic-coated sutures lead to less postoperative delayed wound healing for abdominal wounds versus conventional sutures without the antiseptic coating. SDGC and CHIR-Net conducted a multicenter study across Germany, the PROUD study, to determine this. Within two-and-a-half years, more than 1,200 patients were being recruited and data analyzed. The trial result is now being introduced at the Surgery Congress in Berlin. The trial was able to demonstrate the need for a multicenter study. So far there is barely a trial that recruits this many patients in such a short amount of time, provides prompt analysis and publishes the results for implementation in clinical routine." Evidence based surgery needs to also be accepted by patients of course - there is really no lack of data: "Hospitals collect data, but data research is rarely ever performed. Data fusion needs to be expanded."

No trial without patients

One important factor in clinical trials is the patients, who "make themselves available" for a study. They need to be well informed on which trial they are being considered for and whether it is in their best interest to participate in a trial. The ECRAN project (European Communication on Research Awareness Needs) aims to better inform EU citizens about clinical trials. The project is sponsored by the European Union and comprehensively explains in a video for instance why trials are necessary. The project, which is available in several languages online, also refers to projects with similar goals. To physicians, who want to obtain patients for a trial, this presents an opportunity to inform their patients and to emphasize that trials contribute to safety - even in the operating room.

Have a look at the video about clinical trials by ECRAN project here:
Video: Sailing along with James Lind!

Source: ECRAN Projekt
Foto: Simone Ernst; Copyright: B. Frommann

© B. Frommann

The article was written by Simone Ernst and translated from German by Elena O'Meara.