The indications for Open Abdomen (OA) are generally trauma, abdominal sepsis, severe acute pancreatitis and in general situations in which is ongoing the development an intra-abdominal hypertension condition (IAH), in order to prevent the development of abdominal compartmental syndrome (ACS).
The concept of abdominal damage control surgery (DCS) has two basic components; controlling bleeding and contamination in the abdominal cavity, and leaving the abdomen open, to decompress or facilitate return at planned re-laparotomy.
Maintaining the abdomen domain requires a temporary abdominal closure (TAC). Unlike in trauma patients with massive bleeding, the main aims of the OA approach both in severe secondary peritonitis and severe acute pancreatitis (SAP) are sepsis control and expedite subsequent surgical interventions. In case of abdominal compartment syndrome goal directed therapy to achieve early opening and early closure is the key: paradigm of closure shifts to combination of therapies including negative pressure wound therapy and dynamic closure, in order to reduce complications and avoid incisional hernia.
There have been huge studies and progress in survival of critically ill trauma and septic surgical patients: this in part has been through the great work of pioneers, scientific societies and their guidelines; however further studies and continued innovation are needed to better understand optimal treatment strategies and to define more clearly the indications, because OA by itself is still a morbid procedure. In fact, mortality rates are high, usually over >30% depending on the patient cohort. The challenging situation to manage requires a multidisciplinary approach by the surgeon and the ICU team in a specific staged process.
Even few systematic review and meta-analysis have been published about the topic but no definitive data could be obtained. Lastly no sufficient data about the closure and follow-up of patients treated with OA strategies exist.
To overcome this lack of high level of evidence data about the OA indications, management, definitive closure and follow-up, Clinical Registers® and the World Society of Emergency Surgery (WSES) promoted the International Register of Open Abdomen (IROA).
This prospective observational trial aims to enrol patients undergone to any kind of OA procedure.
The web-based philosophy of the register will give the opportunity to all surgeons and physicians treating with OA patients to participate. This will allow to all of them to participate from all around the world only by having a computer and a web connection.
The data insertion will be possible after registration to the web platform. Each physician will get personal credentials that will allow him/her to register patients. Data will be enrolled and kept protected by a certified system of data encryptation.
The IROA protocol has been approved by the coordinating centre Ethical Committee (Papa Giovanni XXIII hospital, Bergamo, Italy). IROA has also been registered to ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT02382770). All necessary documents can be downloaded from the dedicate section of the website. A free access web-site part will allow to all those who may need more information, to obtain them without the necessity of registration. Each year will be published a paper containing the registered data with all the names of participating physicians listed ad co-authors. All physicians who enrolled patients can ask to have their own data according to the protocol rules and can see them in the personal section of the site.
Clinical Registers® and WSES strongly believe in the necessity to diffuse emergency and trauma surgery as well as acute care surgery knowledge and to create diffuse collaboration in worldwide scientific projects.