ExuCheck seeks to provide a breakthrough in the early detection of infection resulting from colorectal anastomosis leakage, a potentially fatal complication of colorectal surgery. The innovation includes a sensor that constantly monitors wound drainage, as well as an algorithm to analyse the biomarkers that are measured.

Origins

Despite the progress made in surgical techniques and perioperative management, morbidity and mortality after colorectal surgery remain problematic. One of the major causes is colorectal anastomotic leakage (CAL), which occurs in 3% to 20% of patients. The median day of diagnosis, based on clinical signs and confirmed by CT-scan, varies from postoperative days 8 to 13. This indicates that many early stages of CAL are not diagnosed until progressing to a severe state.

Team

Key experts:

• Medical device development, manufacturing: Dagmar Guyader of Medtronic
• User needs, usability evaluation: Christel Schwartz of UGA and Camille Roux of Floralis
• Sensor research and innovation: Karen Monsalve-Grijalba and Pascal Mailley of CEA-Leti
• Communication system, HMI: Bernard Stempin of Maatel
• Medical device clinical investigation: Pim Edomskis of Erasmus MC
• Medical supervision: Pr Faucheron and Dr Trilling of UGA/CHUGA
• Technology transfer: Frédéric Rufi of Bürkert

The project

The consortium involved in ExuCheck is developing a complete monitoring system to allow for much earlier detection of infection resulting from colorectal anastomosis leakage. This project will allow the consortium to mature the system and bring it to the door of clinical evaluation. The solution is structured around three innovative subsystems:

• The analytical device, including pH and lactate sensors, to continuously measure the concentration of biomarkers in bodily fluids (exudates), and the electronic controller, to read and send the data to a display – with smartphone via an app or with a monitoring platform via the hospital central server. The analytical device will be inserted seamlessly by medical staff into the drain line classically used after colorectal surgery. Its design must ensure smooth adoption by the medical teams and should limit surgical procedure modifications.
• The clinical algorithm, to trigger alerts according to biomarker changes. The algorithm will be established based on data provided by a medico-economic clinical trial.
• The clinician interface, to allow the clinicians to follow the evolution of biomarkers and receive alerts. A usability study will provide inputs for development of the interface.

Impact

Earlier detection will limit post-operative complications and allow conservative measures, helping limit the chronic diseases associated to anastomotic leakage, such as colorectal cancer and permanent colostomy. Patients will benefit from improved post-operative follow-up and better long-term quality of life. Medical professionals will benefit from improved and continuous monitoring of post-operative infections. Payers benefit from decreased re-admission rate and more efficient treatment.

Why this is an EIT Health project

This project is in keeping with the EIT Health Focus Area of “Healthcare Continuum Pathways” because it offers a preventive solution with the potential to help check and reduce the onset of chronic conditions and fatalities.

External partner

Maatel