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Post-Operative Ileus Sensor-based Evaluation POISE

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A small, non-invasive sensor patch worn on the abdomen will continuously monitor bowel muscle activity in patients recovering from major abdominal surgery, aiming to detect a common complication called post-operative ileus (POI) before symptoms appear. This matters because POI—a temporary shutdown of normal bowel function—affects up to 20% of the 250,000 patients who undergo abdominal surgery each year in England’s NHS. It prolongs hospital stays by up to 10 days, increases care costs by roughly 70%, and causes vomiting, painful distension, and higher sepsis risk. Current diagnosis relies on imprecise patient-reported milestones like first flatus or stool, leading to inconsistent care. The POISE system tracks the cyclic muscle contractions (migrating motor complexes) that define healthy bowel activity, providing objective, real-time metrics for clinicians. If successful, POISE could allow earlier, pre-symptomatic intervention for POI, shortening hospital stays, reducing complications, and lowering NHS costs. The project will also develop health economic models and a roadmap for NHS adoption. Beyond this study, the technology might eventually support post-surgery recovery at home or help manage chronic bowel conditions.

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Research Question Post-Operative Ileus Sensor-based Evaluation (POISE) PDA: How can we overcome the lack of bowel monitoring capability for patients having undergone major abdominal surgery, and can a novel monitoring solution improve postoperative ileus (POI) management? Background Over 250,000 patients undergo abdominal surgery annually in England s NHS, with POI a common complication affecting up to 20%. POI prolongs hospital stay (up to 10 days, ~70% cost-of-care increase), causes vomiting, painful distension and increases sepsis risk. Intervention includes nasogastric decompression and artificial nutrition. Earlier, pre-symptomatic POI detection and intervention would improve recovery and reduce care costs. Accordingly, POI is a UK research priority. Susceptibility to POI cannot be predicted and diagnosis is a key challenge. Current protocols use recovery metrics based on imprecise, patient-reported clinical timing measures (first flatus, first stool, first tolerated solid food), leading to variable clinical management. The efficacy of conventional bowel auscultation is inconclusive. Normal bowel function is cyclic (migrating motor complexes, MMCs, typical period 90-120min), comprising active and quiescent periods of muscular activity. The POISE system, comprising a reusable, non-invasive sensor patch worn on the abdomen, continuously monitors for muscle contraction activity and analysis algorithms characterise bowel activity into simple, objective and clinically-relevant metrics. A healthy volunteer study confirmed bowel activity data acquisition, a feasibility study confirmed the potential to function in NHS workflows. A usability study mapped simulated ward use. Aims and Objectives Primary aim A1: Develop a bowel activity monitoring tool for assessing recovery after abdominal surgery. Primary objective O1: Map stakeholder needs; develop and validate sensor hardware/software; conduct a two-phase clinical study to establish safety and performance. A2/O2: Develop the POISE system to report bowel cyclic activity, supporting clinician-led assessment of patient recovery; Build a demographically diverse dataset of bowel patterns; Develop training materials for clinicians. A3/O3: Demonstrate POISE s clinical utility and safety on the ward; Conduct ward-based clinical study using production-ready hardware and software algorithms. A4/O4: Develop health economic models and define pathway to adoption; Model holistic impact of POISE, consulting stakeholders, study outcomes, socio-economic and environmental factors. Outline clear path to NHS adoption with defined milestones and financing plans. Methods WP1: Mature hardware for regulatory compliance and manufacture. WP2: Integrate analytics algorithms into robust, compliant software. WP3: Two-part clinical study: Phase A: healthy volunteers (n=100, diverse adult population). Phase B: abdominal surgery patients (n=60). WP4: PPIE and stakeholder involvement. Identify patient acceptance and expectations, capture stakeholder needs, feed into WP1-3 activities. WP5: CE/UKCA regulatory strategy, ISO13485 implementation, MHRA/IRAS approvals. WP6: Early Health Economics, prepare NHS adoption roadmap. S1: Project management S2: IP and FTO Timelines 36 months (November 2025 to November 2028). Y1: Refine TRL-4 prototypes considering manufacture, robustness, cost. Y2: Complete two-phase study. Y3: Metrics of success, progress towards regulatory approval/commercialisation. Impact and Dissemination POISE provides the much-needed means to monitor functional bowel activity during the critical first days of post-surgery recovery. Study outcomes will target high-impact and specialist publications. Future potential exists for post-surgery home recovery and the management of IBDs.

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