AIMS Clinical Research Network

Surgical experience teaches that patients, in addition to being the aim of all clinical activity, are also the main resource for continuing to develop our knowledge.

Thanks to the questions and provocations that arise from the care of our patients, we can find the incentives to seek new therapies, develop new technologies and new organizational structures that are increasingly adequate to meet the needs of care.

Planning a clinical study, applying a research protocol, but also performing a serious retrospective analysis of the activity that has been carried out, in practice they turn out to be very complex operations. Often research attempts encounter failure or in any case fade gradually, clashing with serious practical problems that show that an adequate understanding of what clinical research is lacking. This is the reason why the surgical field is today one of the poorest in terms of research produced.

Furthermore, in order to obtain the adequate volumes and the necessary variability of the sample, it has become essential to share practical experiences and clinical data, in particular among those who practice the same surgical surgical technique.

For this reason, in 2018 the AIMS Academy launched a long-term clinical research program promoting and guiding the creation of a network of hospitals that share and collect clinical data on colorectal surgery. This project resulted in the creation of the AIMS Academy Clinical Research Network.

The network is led by AIMS and enjoys collaboration with the colorectal surgery department at the Mayo Clinic in Rochester, one of the most important research institutes in the United States. AIMS CRN involves six major Italian hospitals, which share clinical data to create a registry, which will be available to respond retrospectively to clinical questions.

AIMS offers an infrastructure suitable for supporting the work of clinicians. The research is governed by a scientific committee and coordinated by a Clinical Research Coordinator. The data are collected through CRF (case report form) shared and collected via the web. The quality of the data is monitored and the expertise of a statistician is offered for setting up data collection and analyzing the results.

Our project involves the following functions:

• Scientific Committee which includes a board of clinical experts
• Clinical Research Coordinator that collects data from different centers and verifies their completeness.
• Statistical: to define the structure of the database and produce periodic processing
• Data manager: dedicated to data input and follow-up of data collection
• IT expert who deals with the integration of IT systems for data collection

During 2018 AIMS CRU started a first multicenter data collection for colorectal research. Thanks to the multi-center collaboration, the data relating to about 600 patients were collected from which important publications are being prepared.

Publications

Mari GM, Achilli P, Maggioni D et al. Creation of a rectal cancer registry in Italy by the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. F1000Research 2019, 8:1736. doi: 10.12688/f1000research.20702.1

Mari G, Crippa J, Borroni G, Cocozza E, Roscio F, Scandroglio I et al. Symptomatic Uncomplicated Diverticular Disease and Incidence of Unexpected Abscess during Sigmoidectomy: A Multicenter Prospective Observational Study. Digestive Surgery. 2019;:1-6. doi: 10.1159/000500084

Mari G, Maggioni D, Crippa J, Costanzi A, Scotti M, Giardini V et al. Compliance to Adjuvant Chemotherapy of Patients Who Underwent Surgery for Rectal Cancer: Report from a Multi-institutional Research Network. World Journal of Surgery. 2019;. doi: 10.1007/s00268-019-05060-5

Perspectives

Since 2019, AIMS CRN, in addition to maintaining and increasing the collection of colorectal data, is preparing data collection focused on new surgical areas.